Initial Combination With Pioglitazone Study (0431-064)

Study Overview
=================
Brief Summary
-----------------
A clinical study to evaluate the safety and efficacy of the initial combination therapy with sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with insulin or oral antihyperglycemic therapy.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Initial Therapy With Coadministration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d
* Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.


Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria: Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes) General Exclusion Criteria: Patient has a history of type 1 diabetes mellitus or history of ketoacidosis Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4 months Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 2 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sitagliptin 100 mg q.d./pioglitazone 30 mg q.d. | Drug: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d<br>* Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.<br>|
| Active Comparator: 2<br>sitagliptin 100 mg placebo q.d./pioglitazone 30 mg q.d. | Drug: Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.<br>* Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and Week 24 | 
| Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and Week 24 |