Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Official Title
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A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
* Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has type 2 diabetes mellitus Males Females who are highly unlikely to become pregnant Patients poorly controlled while taking one or two oral antidiabetic medications Exclusion Criteria: Patient has a history of type 1 diabetes mellitus or history of ketoacidosis Patient required insulin therapy within the prior 8 weeks Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sitagliptin 100 mg once a day (q.d.)/metformin ≥1500 mg a day<br> | Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day<br>* Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.<br>* Other names: Januvia;|
| Placebo Comparator: sitagliptin 100 mg placebo q.d./ metformin ≥ 1500 mg/day<br> | Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day<br>* Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin ≥ 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin ≥ 1500 mg/day will be administered as oral tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in A1C at Week 18 | A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. | Baseline and Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FPG at Week 18 | Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG. | Baseline and Week 18 | 
| Change From Baseline in 2 Hr-PMG at Week 18 | Change from baseline at Week 18 is defined as Week 18 minus Week 0. | Baseline and Week 18 | 
| Change From Baseline in A1C at Week 30 | A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent. | Baseline and Week 30 |