Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alogliptin · 22 trials · 5 indications
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.
An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.
The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.
Safety was assessed by physical examinations, clinical laboratory parameters, electrocardiogram (ECG) readings, vital sign measurements, oral temperature, and hypoglycemic events. Changes in laboratory values or ECG parameters were considered to be adverse events if they were judged to be clinically significant. A TEAE was any event that started on or after the first dose of open-label study drug and within 14 days after the last dose.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at day 85 or final visit and glycosylated hemoglobin collected at baseline.
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.
Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.
Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval in this study).
| Arm | Type | Description |
|---|---|---|
| Metformin HCl 500 mg | ACTIVE_COMPARATOR | Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks. |
| Alogliptin 12.5 mg | ACTIVE_COMPARATOR | Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks. |
| Alogliptin 12.5 mg + Metformin HCl 500 mg FDC | EXPERIMENTAL | Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks. |
| Placebo | PLACEBO_COMPARATOR | Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks. |
| SYR-322 (Alogliptin) QD | EXPERIMENTAL | SYR-322 25 mg, orally. |
| Insulin | PLACEBO_COMPARATOR | injection |
| Alogliptin | EXPERIMENTAL | Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks. |
| Alogliptin Monotherapy | EXPERIMENTAL | Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. |
| Metformin | OTHER | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. |
| Metformin + Alogliptin Add-on Therapy | EXPERIMENTAL | Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. |
| Pioglitazone | OTHER | Participants continued to receive their stable dose of pioglitazone with or without metformin, and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. |
| Pioglitazone + Alogliptin Add-on Therapy | EXPERIMENTAL | Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. |
| Alogliptin 25 QD | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. |
| Alogliptin 12.5 BID | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks. |
| Metformin 500 BID | ACTIVE_COMPARATOR | Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks. |
| Metformin 1000 BID | ACTIVE_COMPARATOR | Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks. |
| Alogliptin 12.5 BID + Metformin 500 BID | EXPERIMENTAL | Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks. |
| Alogliptin 12.5 BID + Metformin 1000 BID | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks. |
| Alogliptin 25 mg QD | EXPERIMENTAL | - |
| Glipizide 5 mg QD | ACTIVE_COMPARATOR | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Alogliptin 25 mg QD + Pioglitazone 30 mg QD | EXPERIMENTAL | - |
| Alogliptin 25 mg + Pioglitazone 30 mg add-on to Metformin | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks. |
| Pioglitazone 45 mg add-on to Metformin | ACTIVE_COMPARATOR | Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks. |
| Pioglitazone 30 mg QD | ACTIVE_COMPARATOR | Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 25 mg QD+ Pioglitazone 30 mg QD | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 12.5 mg QD + Pioglitazone 30 mg QD | ACTIVE_COMPARATOR | Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks. |
| Alogliptin 12.5 mg QD | EXPERIMENTAL | - |
| Alogliptin 25 mg | EXPERIMENTAL | Alogliptin 25 mg tablet, orally, once daily for up to 4 years. |
| Alogliptin 6.25 mg QD | EXPERIMENTAL | - |
| Alogliptin 50 mg QD | EXPERIMENTAL | - |
| Voglibose 0.2 mg TID | ACTIVE_COMPARATOR | - |
| Alogliptin 100 mg QD | EXPERIMENTAL | - |
| Sequence I: ABCD | EXPERIMENTAL | SYR-322-4833 BL (alogliptin 25 \[milligram\] mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 2 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 4 (Regimen D). |
| Sequence II: BCDA | EXPERIMENTAL | Alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 1 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 3 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen A). |
| Sequence III: CDAB | EXPERIMENTAL | SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 1 (Regimen C), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 2 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 3 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 4 (Regimen B). |
| Sequence IV: DABC | EXPERIMENTAL | Alogliptin 25 mg tablet and pioglitazone 30 mg tablet, orally, once, on Day 1 of Period 1 (Regimen D), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 15 mg) FDC tablet, orally, once, on Day 1 of Period 2 (Regimen A), followed by a 7-day washout period, followed by alogliptin 25 mg tablet and pioglitazone 15 mg tablet, orally, once, on Day 1 of Period 3 (Regimen B), followed by a 7-day washout period, followed by SYR-322-4833 BL (alogliptin 25 mg and pioglitazone 30 mg) FDC tablet, orally, once, on Day 1 of Period 4 (Regimen C). |
| Sequence I: AB | EXPERIMENTAL | SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets, orally, once, on Day 1 of Period 1, followed by a 7-day washout period, followed by alogliptin 12.5 mg tablets and metformin 1000 mg tablets, orally, once, on Day 1 of Period 2. |
| Sequence II: BA | EXPERIMENTAL | Alogliptin 12.5 mg tablets, orally and metformin 1000 mg tablets, orally, once, on Day 1 of Period 1, followed by a 7-day washout period, followed by SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets, orally, once, on Day 1 of Period 2. |
| Alogliptin 12.5 mg (age 10 to < 14 years) | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, 1 dose only. |
| Alogliptin 25 mg (age 10 to < 14 years) | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, 1 dose only. |
| Alogliptin 12.5 mg (age 14 to < 18 years) | EXPERIMENTAL | Alogliptin 12.5 mg, tablets, orally, 1 dose only. |
| Alogliptin 25 mg (age 14 to < 18 years) | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, 1 dose only. |
| Alogliptin 25 mg (age 18 to 65 years) | EXPERIMENTAL | Alogliptin 25 mg, tablets, orally, 1 dose only. |
| Name | Type | Description |
|---|---|---|
| Alogliptin | DRUG | Alogliptin tablets |
| Metformin HCl | DRUG | Metformin HCl capsules |
| Alogliptin and Metformin Fixed-Dose Combination (FDC) | DRUG | Alogliptin and metformin FDC tablets |
| Alogliptin Placebo | DRUG | Alogliptin placebo-matching tablets |
| Metformin Placebo | DRUG | Metformin placebo-matching capsules |
| Alogliptin and Metformin FDC Placebo | DRUG | Alogliptin and metformin FDC placebo-matching tablets |
| Insulin | DRUG | Insulin injection |
| Rapid-acting insulin secretagogue | DRUG | Either of the following commercially available rapid-acting insulin secretagogues as prescribed by the Investigator: (i) Nateglinide: Dose: 30 mg tablet or 90 mg tablet (ii) Mitiglinide calcium hydrate: Dose: 5 mg tablet or 10 mg tablet |
| Placebo to alogliptin | DRUG | Alogliptin placebo-matching tablets. |
| Metformin | DRUG | Stable metformin dose |
| Pioglitazone | DRUG | Stable pioglitazone dose |
| Placebo | DRUG | Alogliptin placebo matching tablets |
| Glipizide | DRUG | Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks. |
| Alogliptin and Pioglitazone | DRUG | Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks. |
| Alogliptin and glyburide | DRUG | Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks. |
| Glyburide | DRUG | Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks. |
| Alogliptin and metformin | DRUG | Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks. |
| Alogliptin and insulin | DRUG | Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks. |
| Voglibose | DRUG | Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. |
| SYR-322-4833 BL | DRUG | SYR-322-4833 BL FDC tablets. |
| Metformin Hydrochloride | DRUG | Metformin hydrochloride 1000 mg tablets |
| SYR-322MET | DRUG | SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets |
Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of an...
Alogliptin is a small molecule being studied for use in Type 2 Diabetes Mellitus. It is also being investigated in healthy volunteers for pharmacokinetic and pharmacodynamic studies. The drug is in Phase 3 clinical development for these metabolic indications.
Alogliptin is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials of the drug in patients with Type 2 Diabetes Mellitus.
Alogliptin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All 14 clinical trials listed for the drug have been completed, with none currently active.
Alogliptin has been studied in 14 completed clinical trials with a total enrollment of 8,578 participants. Notable trials include NCT01318070 and NCT01318083, which evaluated the drug in combination with thiazolidine or sulfonylurea in Japanese patients with Type 2 Diabetes Mellitus.
Alogliptin is the primary name for this drug, and no alternative names have been established in the clinical trial data. It is a distinct small molecule being developed for Type 2 Diabetes Mellitus.
Alogliptin is being tested in randomized, double-blind, placebo-controlled trials. The completed studies include combination therapy with thiazolidine, sulfonylurea, or metformin in patients with Type 2 Diabetes Mellitus, as well as pharmacokinetic studies in healthy volunteers.