Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00837577 | MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104) | PHASE3 | COMPLETED | 133 | — | — | Feb 5, 2009 | Aug 11, 2010 | May 15, 2017 | - | — |
| NCT00545584 | Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078) | PHASE3 | COMPLETED | 1,512 | — | — | Apr 1, 2007 | Nov 19, 2009 | May 12, 2017 | - | — |
| NCT00875394 | Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189) | PHASE3 | COMPLETED | 68 | — | — | Feb 1, 2007 | Jun 27, 2008 | May 30, 2017 | - | — |
| NCT00411554 | A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED) | PHASE3 | COMPLETED | 319 | — | — | Jan 1, 2007 | Aug 1, 2007 | Feb 5, 2016 | - | — |
| NCT00758069 | Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045) | PHASE2 | COMPLETED | 80 | — | — | Jul 3, 2005 | Feb 13, 2006 | May 5, 2017 | - | — |
Change from baseline measurement, where the baseline measurement was obtained at randomization (Week 0) before receiving study medication. This study used Japan Diabetes Society (JDS)-certified HbA1c values, the standard at the time when the study was conducted (HbA1c \[National Glycohemoglobin Standardization Program; NGSP\] = HbA1c (JDS-HbA1c \[%\]) + 0.4%).
Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
| Arm | Type | Description |
|---|---|---|
| Sitagliptin/Sitagliptin | EXPERIMENTAL | - |
| Placebo/Sitagliptin | EXPERIMENTAL | - |
| Sitagliptin with Standard of Care | EXPERIMENTAL | Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet. |
| Sitagliptin with Diet Advice | EXPERIMENTAL | Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary |
| Sitagliptin with Diet and Physical Activity Advice | EXPERIMENTAL | Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week. |
| 1 | EXPERIMENTAL | sitagliptin + metformin |
| 2 | ACTIVE_COMPARATOR | metformin + any other oral antidiabetic drug |
| 3 | ACTIVE_COMPARATOR | metformin |
| Sitagliptin 50 mg QD | EXPERIMENTAL | sitagliptin 50 mg orally once daily (QD=once daily) |
| Voglibose 0.2 mg TID | ACTIVE_COMPARATOR | voglibose 0.2 mg orally three times daily (TID= three times daily) |
| Name | Type | Description |
|---|---|---|
| Comparator: Placebo | DRUG | Placebo to sitagliptin once daily for 12 weeks (double-blind period) |
| Sitagliptin | DRUG | Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period). Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20. |
| Voglibose | DRUG | All participants received a stable dose of voglibose, in accordance with the package insert, throughout the study. |
| sitagliptin phosphate | DRUG | sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks |
| Comparator: Diet | BEHAVIORAL | Diet |
| Comparator: Physical Activity | BEHAVIORAL | Physical Activity |
| Comparator: metformin | DRUG | metformin 850 mg Twice a day (BID) for 24 weeks |
| Comparator: Antidiabetic Standard of Care | DRUG | Patient can take any oral antidiabetic drug (other than metformin) |
| Comparator: voglibose | DRUG | voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks |
| Comparator: Sitagliptin | DRUG | 50 mg twice daily (BID), taken orally for 4 weeks |
Inclusion Criteria: * Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control On Diet/Exercise Therapy And Voglibose Monotherapy Exclusion Criteria: * Patients Have A History Of Type 1 Diabetes Mellitus