A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

Study Overview
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Brief Summary
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A study to see if better control of type 2 diabetes can occur in patients taking a stable dose of metformin when they are also provided either sitagliptin or glimepiride. This study will also see if this treatment is safe and tolerable.

Official Title
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A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Conditions
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Type 2 Diabetes Mellitus, Non Insulin Dependent, Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: sitagliptin
* Drug: Comparator: glimepiride
* Drug: open-label metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Diagnosed with type 2 diabetes On a stable dose of metformin of at least 1500 mg per day Exclusion Criteria: History of type 1 diabetes Pregnant HIV positive On a weight loss program or medication Has a history of blood disorder, certain cancers, heart, liver or kidney disease

Ages Eligible for Study
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Minimum Age: 18 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: 1<br>sitagliptin | Drug: sitagliptin<br>* Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks<br>* Other names: Januvia;Drug: open-label metformin<br>* open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.<br>* Other names: metformin;|
| Active Comparator: 2<br>glimepiride | Drug: Comparator: glimepiride<br>* glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.<br>Drug: open-label metformin<br>* open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.<br>* Other names: metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at Week 30 | Patient-level HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the Week 0 HbA1c percent. | Week 0 to Week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. | Week 0 to Week 30 | 
| Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 |  | Week 0 to Week 30 | 
| Change From Baseline in Body Weight at Week 30 | Change from baseline at Week 30 was defined as Week 30 minus Week 0. | Week 0 to Week 30 | 
| Percent of Patients With A1C <7.0% at Week 30 |  | Week 30 | 
| Percent of Patients With A1C <6.5% at Week 30 |  | Week 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Non Insulin Dependent