Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Omarigliptin · 12 trials · 5 indications
A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue. The safety database was analyzed in a standard fashion in the all participants as treated (APaT) population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above).
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue. The safety database was analyzed in a standard fashion in the APaT population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above).
A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs.
A1C (%) is used to report average blood glucose levels over prolonged periods of time. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis).
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.
Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.
C168h is a measure of the plasma drug concentration 168 hours post-dose.
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F.
fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.
Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F.
Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.
T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.
| Arm | Type | Description |
|---|---|---|
| Omarigliptin 25 mg once weekly | EXPERIMENTAL | Participants receive omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. |
| Sitagliptin 100 mg once daily | ACTIVE_COMPARATOR | Participants receive sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy. |
| Omarigliptin 25 mg | EXPERIMENTAL | Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited. |
| Placebo | PLACEBO_COMPARATOR | Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited. |
| Omarigliptin (Phase A) → Omarigliptin (Phase B) | EXPERIMENTAL | Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks. Participants will continue pre-study metformin throughout the duration of the study. If necessary, rescue therapy may be initiated (open-label glimepiride during Phase A and insulin glargine during Phase B). |
| Placebo to omarigliptin (Phase A) → Glimepiride (Phase B) | PLACEBO_COMPARATOR | Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks. Participants will continue pre-study metformin throughout the duration of the study. If necessary, rescue therapy may be initiated (open-label glimepiride during Phase A and insulin glargine during Phase B). |
| Omarigliptin | EXPERIMENTAL | Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B. |
| Placebo to Omarigliptin | PLACEBO_COMPARATOR | Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B. |
| Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B) | EXPERIMENTAL | Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study. |
| Omarigliptin 25 mg/Glinides (Phase A+B) | EXPERIMENTAL | Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study. |
| Omarigliptin 25 mg/biguanides (BGs) (Phase A+B) | EXPERIMENTAL | Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study. |
| Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B) | EXPERIMENTAL | Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study. |
| Omarigliptin 25 mg/α-GIs (Phase A+B) | EXPERIMENTAL | Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study. |
| Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B) | PLACEBO_COMPARATOR | Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study. |
| Placebo/Glinides (Phase A) → Omarigliptin 25 mg/Gln. (Phase B) | PLACEBO_COMPARATOR | Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of glinides throughout the duration of the study. |
| Placebo/BGs (Phase A) → Omarigliptin 25 mg/BGs (Phase B) | PLACEBO_COMPARATOR | Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BGs throughout the duration of the study. |
| Placebo/TZDs (Phase A) → Omarigliptin 25 mg/TZDs (Phase B) | PLACEBO_COMPARATOR | Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZDs throughout the duration of the study. |
| Placebo/α-GIs (Phase A) → Omarigliptin 25 mg/α-GIs (Phase B) | PLACEBO_COMPARATOR | Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GIs inhibitors throughout the duration of the study. |
| Omarigliptin 25 mg (Phase A+B) | EXPERIMENTAL | Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) |
| Sitagliptin (Phase A) switching to Omarigliptin (Phase B) | ACTIVE_COMPARATOR | Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) |
| Placebo (Phase A) switching to Omarigliptin (Phase B) | PLACEBO_COMPARATOR | Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) |
| Placebo to omarigliptin (Phase A) → Glipizide (Phase B) | ACTIVE_COMPARATOR | Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) will receive glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54). |
| Glimepiride | ACTIVE_COMPARATOR | Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks. |
| Omarigliptin 0.25 mg (Base) | EXPERIMENTAL | Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) |
| Omarigliptin 1 mg (Base) | EXPERIMENTAL | Omarigliptin 1 mg administered once weekly for 12 weeks (Base) |
| Omarigliptin 3 mg (Base) | EXPERIMENTAL | Omarigliptin 3 mg administered once weekly for 12 weeks (Base) |
| Omarigliptin 10 mg (Base) | EXPERIMENTAL | Omarigliptin 10 mg administered once weekly for 12 weeks (Base) |
| Omarigliptin 25 mg (Base) | EXPERIMENTAL | Omarigliptin 25 mg administered once weekly for 12 weeks (Base) |
| Placebo (Base) | PLACEBO_COMPARATOR | Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) |
| Pooled omarigliptin (Extension) | EXPERIMENTAL | Participants who received omarigliptin during the base study, received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (Extension). |
| Placebo/Metformin | ACTIVE_COMPARATOR | Participants who received matching placebo to omarigliptin during the base period, received pioglitazone administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (extension period). Note: A protocol amendment removed pioglitazone during the extension period. Participants discontinued pioglitazone and switched to blinded metformin. Participants who were previously rescued with open-label metformin during the base period continued in the extension period on open-label metformin. |
| Part 1: Mild Renal Impairment (Panel A) | EXPERIMENTAL | - |
| Part 1: Control to Match Panel A (Panel B) | EXPERIMENTAL | - |
| Part 1: Moderate Renal Impairment (Panel C) | EXPERIMENTAL | - |
| Part 1: Control to Match Panel C (Panel D) | EXPERIMENTAL | - |
| Part 1: Severe Renal Impairment (Panel E) | EXPERIMENTAL | - |
| Part 1: Control to Match Panel E (Panel F) | EXPERIMENTAL | - |
| Part 2: End-stage Renal Disease needing hemodialysis (Panel G) | EXPERIMENTAL | - |
| Part 2: Control to Match Panel G (Panel H) | EXPERIMENTAL | - |
| Healthy Omarigliptin | EXPERIMENTAL | Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A). |
| Healthy Placebo | PLACEBO_COMPARATOR | Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A). |
| T2D Omarigliptin | EXPERIMENTAL | Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B). |
| T2D Placebo | PLACEBO_COMPARATOR | Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B). |
| Name | Type | Description |
|---|---|---|
| Omarigliptin | DRUG | Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks |
| Sitagliptin | DRUG | Sitagliptin 100 mg oral tablet once a day for 24 weeks |
| Placebo to omarigliptin | DRUG | Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks |
| Placebo to Sitagliptin | DRUG | Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks |
| Open-label Metformin | DRUG | Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day |
| Open-label Glimepiride | DRUG | Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy |
| Metformin | DRUG | Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited. |
| Matching placebo to omarigliptin | DRUG | Matching placebo to omarigliptin capsule administered orally once weekly (preferably on the same day of each week) |
| Glimepiride | DRUG | Glimepiride 1 or 2 mg tablet/capsule administered orally once daily and up-titrated to a maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B. |
| Matching placebo to glimepiride | DRUG | Matching placebo to glimepiride tablet/capsule administered orally once daily and up-titrated to a mock maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B. |
| Insulin glargine | DRUG | During Phase B of the study, participants who received a maximum up-titration of open-label glimepiride or blinded glimepiride/matching placebo to glimepiride, may be rescued with open-label insulin glargine. |
| Placebo to metformin | DRUG | During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study). |
| Glipizide | DRUG | Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54). |
| Placebo to glipizide | DRUG | Matching placebo to glipizide daily |
| Insulin | BIOLOGICAL | Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator. |
| Glimepiride Placebo | DRUG | - |
| Pioglitazone | DRUG | Pioglitazone 15 mg oral tablet or capsule administered once daily |
| Placebo | DRUG | Once-weekly placebo capsule |
Inclusion Criteria: * Type 2 diabetes mellitus * Currently on a stable dose of metformin monotherapy (≥1500 mg per day) for at least 12 weeks prior to study participation * Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activ...
Omarigliptin is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It has been studied in patients with inadequate glycemic control, including those with chronic renal insufficiency. The drug is in clinical development but is not approved.
Omarigliptin is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company has sponsored multiple clinical trials of the drug across various phases.
Omarigliptin is currently in Phase 1 clinical development. While it has completed Phase 2 and Phase 3 trials, the most advanced ongoing development stage is Phase 1, and the drug remains investigational and not approved.
Omarigliptin has been studied in several completed trials, including NCT01217073 (Phase 2 dose-range finding), NCT01407276 (Phase 1 in renal impairment), NCT01814748 (Phase 3 in younger adults), and NCT01841697 (Phase 3 comparing to sitagliptin). All trials are completed.
Yes, Omarigliptin is also known as MK-3102. Clinical trial titles and records refer to the drug by both names, such as in NCT01407276, which is titled 'A Study of Omarigliptin (MK-3102) in Participants With Impaired Renal Function.'
Omarigliptin is a small molecule that targets dipeptidyl peptidase-4 (DPP-4), an enzyme involved in glucose metabolism. By inhibiting DPP-4, it helps regulate blood sugar levels in patients with Type 2 Diabetes Mellitus.