Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.

Official Title
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A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial in China to Study the Safety and Efficacy of Co-administration of Sitagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Sitagliptin 50 mg
* Drug: Metformin 500 mg
* Drug: Sitagliptin 100 mg
* Drug: Placebo
* Drug: Metformin 850 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has type 2 diabetes mellitus is male, a female who cannot have children, or a female who agrees to use birth control during the study is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%) Exclusion Criteria: Patient has type 1 diabetes mellitus or ketoacidosis Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) Patient is on a weight loss program not in the maintenance phase or on a weight loss medication Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer Patient is HIV positive Patient is pregnant

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 50 mg + metformin 500 mg<br>Sitagliptin 50 mg and metformin 500 mg twice a day for 24 weeks. | Drug: Sitagliptin 50 mg<br>* Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.<br>* Other names: Januvia®, Tesavel®, Xelevia®, Ristaben®;Drug: Metformin 500 mg<br>* Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.<br>* Other names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®;|
| Experimental: Sitagliptin 50 mg + metformin 850 mg<br>Sitagliptin 50 mg and metformin 850 mg twice a day for 24 weeks. | Drug: Sitagliptin 50 mg<br>* Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.<br>* Other names: Januvia®, Tesavel®, Xelevia®, Ristaben®;Drug: Metformin 850 mg<br>* Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.<br>* Other names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®;|
| Active Comparator: Metformin 500 mg<br>Metformin 500 mg twice daily for 24 weeks. | Drug: Metformin 500 mg<br>* Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.<br>* Other names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®;|
| Active Comparator: Metformin 850 mg<br>Metformin 850 mg twice daily for 24 weeks. | Drug: Metformin 850 mg<br>* Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.<br>* Other names: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®;|
| Experimental: Sitagliptin 100 mg<br>Sitagliptin 100 mg once daily for 24 weeks. | Drug: Sitagliptin 100 mg<br>* Sitagliptin 100 mg once daily for 24 weeks.<br>* Other names: Januvia®, Tesavel®, Xelevia®, Ristaben®;|
| Placebo Comparator: Placebo<br>Matching placebo tablets for 24 weeks. | Drug: Placebo<br>* Matching placebo tablets to sitagliptin or metformin for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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