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Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00086515
First received: July 2, 2004
Last updated: April 27, 2015
Last verified: April 2015
History of Changes
  Purpose
The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Condition Intervention Phase
Diabetes Mellitus, Type II
 Drug: Sitagliptin (MK0431)
Drug: Placebo/Glipizide 5 mg
Drug: Metformin
Drug: Pioglitazone
 Phase 3

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 Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

    A1C is measured as a percent. Thus, this change from

    baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.



Secondary Outcome Measures:
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

    Change from baseline at Week 24 is defined as FPG at

    Week 24 minus FPG at Week 0.


  • Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
Enrollment: 701
Study Start Date: June 2004
Study Completion Date: February 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin 100 mg
The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
 Drug: Sitagliptin (MK0431)
Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
Other Names:
  • MK0431
  • sitagliptin phosphate
  • Januvia
Drug: Metformin
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
Drug: Pioglitazone
Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
Other Name: ACTOS
Placebo Comparator: Placebo / Glipizide 5 mg
The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.
 Drug: Placebo/Glipizide 5 mg
Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
Drug: Metformin
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
Drug: Pioglitazone
Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
Other Name: ACTOS

  Eligibility
Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
  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: NCT00086515

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

Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00086515     History of Changes
Other Study ID Numbers: 0431-020  Formally-B0604T2DMT  2006_411 
Study First Received: July 2, 2004
Results First Received: November 19, 2010
Last Updated: April 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 Diabetes Mellitus

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

ClinicalTrials.gov processed this record on September 28, 2016