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)

Phase 3

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: sitagliptin phosphate

• Registration Number: NCT00875394
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-01
• Primary Completion: 2008-06-27
• Study Completion: 2008-06-27
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Results First Submitted: 2009-06-12
• Results First Submitted QC: 2011-03-22
• Results First Posted: 2011-04-20
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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%

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Exclusion Criteria

• Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sitagliptin phosphate	sitagliptin + metformin

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24	Baseline and 24 weeks	Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.