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)

Study Overview
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Brief Summary
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After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Official Title
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A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Drug: sitagliptin phosphate
* Drug: Comparator: metformin
* Drug: Comparator: metformin
* Drug: Comparator: Antidiabetic Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient Has Type 2 Diabetes Mellitus Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent Patient Is Currently On Metformin Therapy (1500 Mg/Day) Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent Patient Has An A1c of 6.5 % - 11.0% Exclusion Criteria: Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis

Ages Eligible for Study
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Minimum Age: 30 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sitagliptin + metformin | Drug: sitagliptin phosphate<br>* sitagliptin 100 mg Once a day (QD) for 24 weeks<br>* Other names: sitagliptin;Drug: Comparator: metformin<br>* metformin 850 mg Twice a day (BID) for 24 weeks<br>* Other names: metformin;|
| Active Comparator: 2<br>metformin + any other oral antidiabetic drug | Drug: Comparator: metformin<br>* metformin 850 mg Twice a day (BID) for 24 weeks<br>* Other names: metformin;Drug: Comparator: Antidiabetic Standard of Care<br>* Patient can take any oral antidiabetic drug (other than metformin)<br>|
| Active Comparator: 3<br>metformin | Drug: Comparator: metformin<br>* metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks<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 Glycosylated Hemoglobin A1C (A1C) at Week 24 | Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is percent. Thus, this measure represents a difference of percent values. | Baseline and 24 weeks |