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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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: MK-0893
Drug: Sitagliptin
Drug: Metformin
Drug: Placebo for MK-0893
Drug: Placebo for Sitagliptin
Drug: Placebo for Metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 146
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0893 + Sitagliptin 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: 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 + Metformin 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: 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 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).
Active Comparator: Sitagliptin + Metformin 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631488

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00631488     History of Changes
Other Study ID Numbers: MK-0893-015, 2007_646
Study First Received: February 21, 2008
Results First Received: October 7, 2011
Last Updated: January 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014