A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: MK-0893; Drug: Sitagliptin; Drug: Metformin; Drug: Placebo for Metformin; Drug: Placebo for MK-0893; Drug: Placebo for Sitagliptin

• Registration Number: NCT00631488
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-03-07
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2011-10-07
• Results First Submitted QC: 2012-01-14
• Results First Posted: 2012-02-17
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria

• Participants have a history of Type 1 Diabetes Mellitus
• Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor [PPAR]-gamma agonists)
• Participants who have a contraindication to metformin or sitagliptin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0893 + Sitagliptin	Sitagliptin	-
MK-0893 + Sitagliptin	Placebo for Metformin	-
MK-0893 + Metformin	MK-0893	-
Sitagliptin + Metformin	Placebo for MK-0893	-
MK-0893 + Metformin	Placebo for Sitagliptin	-
MK-0893 + Sitagliptin	MK-0893	-
MK-0893 + Metformin	Metformin	-
Sitagliptin + Metformin	Sitagliptin	-
Sitagliptin + Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels	BL, 4 weeks (end of double-blind treatment period)

Secondary Outcome Measures

Name	Time	Method
Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC	BL, 4 weeks (end of double-blind treatment period)	Glucagon-Like Peptide-1 (GLP-1) is an incretin hormone that acts as a potent insulin secretegogue in response to nutrient ingestion and stimulates glucose disposition. The total AUC of Total GLP-1 levels was calculated from blood sample data measured after the morning meal.
Change From BL to Week 4 in Fasting Plasma Glucose (FPG)	BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)	BL, 4 weeks (end of double-blind treatment period)
Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC	BL, 4 weeks (end of double-blind treatment period)	GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. The total AUC of Active GLP-1 levels was calculated from blood sample data measured after the morning meal.