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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00631488
First received: February 21, 2008
Last updated: January 14, 2012
Last verified: January 2012

February 21, 2008
January 14, 2012
February 2008
January 2009   (final data collection date for primary outcome measure)
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ] [ Designated as safety issue: No ]
The effect of treatment of MK0893 in combination with sitagliptin or with metformin compared to the combination of sitagliptin and metformin on 24-hour weighted mean glucose levels after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00631488 on ClinicalTrials.gov Archive Site
  • Change From BL to Week 4 in Fasting Plasma Glucose (FPG) [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ] [ Designated as safety issue: No ]
  • Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC) [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ] [ Designated as safety issue: No ]
  • Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ] [ Designated as safety issue: No ]
    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 the 2-Hour Active GLP-1 Total AUC [ Time Frame: BL, 4 weeks (end of double-blind treatment period) ] [ Designated as safety issue: No ]
    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.
To assess the safety and tolerability of MK0893 after 4 weeks [ Time Frame: after 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study to Test the Effectiveness and Safety of MK0893 in Combination With Other Drugs Used to Treat Type 2 Diabetes (0893-015)(COMPLETED)
A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: MK-0893
    Initial loading dose of 200 mg MK-0893 at randomization, followed by MK-0893 administered orally as 40 mg tablets daily throughout the double-blind treatment period (4 weeks).
  • Drug: Sitagliptin
    Sitagliptin Phosphate administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
    Other Names:
    • Sitagliptin
    • JANUVIA™
    • MK0431
  • Drug: Metformin
    Metformin taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin then administered throughout the double-blind treatment period (4 weeks).
    Other Names:
    • Metformin
    • GLUCOPHAGE®
  • Drug: Placebo for MK-0893
    Matching placebo for MK-0893 was orally administered for the loading dose (200 mg) and for the following daily treatment (40 mg) over the 4 week double blind treatment period.
  • Drug: Placebo for Sitagliptin
    Matching placebo for Sitagliptin (100 mg) administered orally as 100 mg tablets daily before the morning meal throughout the double-blind treatment period (4 weeks).
  • Drug: Placebo for Metformin
    Metformin-matched placebo taken orally (500 mg tablets) over an initial 2-week titration period starting at 500 mg administered twice daily before the morning and evening meals, increasing to 1500 mg daily, and ending with 1000 mg twice daily. Metformin-matched placebo then administered throughout the double-blind treatment period (4 weeks).
  • Experimental: MK-0893 + Sitagliptin
    Interventions:
    • Drug: MK-0893
    • Drug: Sitagliptin
    • Drug: Placebo for Metformin
  • Experimental: MK-0893 + Metformin
    Interventions:
    • Drug: MK-0893
    • Drug: Metformin
    • Drug: Placebo for Sitagliptin
  • Active Comparator: Sitagliptin + Metformin
    Interventions:
    • Drug: Sitagliptin
    • Drug: Metformin
    • Drug: Placebo for MK-0893
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00631488
MK-0893-015, 2007_646
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP