Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: sitagliptin phosphate

• Registration Number: NCT00541229
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-08-24
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-10
• Primary Completion: 2008-06-17
• Study Completion: 2008-07-01
• Results First Submitted: 2009-06-05
• Results First Submitted QC: 2009-06-05
• Results First Posted: 2009-07-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Patient has Type 2 Diabetes
• Patient is between the ages of 30-65 years
• Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

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Exclusion Criteria

• Patient has Type 1 Diabetes
• Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
• Patient has taken insulin within the past 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	sitagliptin phosphate	sitagliptin 100 mg
2	sitagliptin phosphate	sitagliptin 200 mg

Primary Outcome Measures

Name	Time	Method
24-hour Weighted Mean Glucose (WMG)	Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only.	The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method.