Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus (MK-0431A-202 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00993187
First received: October 9, 2009
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

This study will assess the effect of MK-0431A compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, MK-0431A provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.


Condition Intervention Phase
Diabetes Mellitus, Non-insulin-dependent
Drug: MK-0431A
Drug: Comparator: Glimepiride
Drug: Matching placebo to MK-0431A
Drug: Matching placebo to glimepiride
Phase 4

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 Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (Janumet®) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in HbA1c at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
  • Number of participants who experience at least one adverse event [ Time Frame: Up to 40 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued study drug due to an adverse event [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose (FPG) at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
  • Number of participants with hypoglycemic events [ Time Frame: up to Week 30 ] [ Designated as safety issue: Yes ]
  • The change from baseline in body weight at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: Yes ]
  • Number of participants with HbA1c < 7.0% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]

Enrollment: 292
Study Start Date: May 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0431A
MK-0431A up to 50/1000 mg twice daily (BID) plus matching placebo to glimepiride daily for 30 weeks
Drug: MK-0431A
MK-0431A (sitagliptin phosphate plus metformin hydrochloride) combination tablet orally up to 50/1000 mg BID for 30 weeks
Other Name: Janumet®
Drug: Matching placebo to glimepiride
Matching placebo to glimepiride tablet orally daily for 30 weeks
Active Comparator: Glimepiride
Glimepiride up to 6 mg daily plus matching placebo to MK-0431A BID for 30 weeks
Drug: Comparator: Glimepiride
Glimepiride tablet orally up to 6 mg daily for 30 Weeks
Other Name: Amaryl®
Drug: Matching placebo to MK-0431A
Matching placebo to MK-0431A tablet orally BID for 30 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has type 2 diabetes mellitus
  • Is currently not on an anti-hypoglycemic agent (AHA) (off for at least 12 weeks) and has a Visit 1/Screening Visit HbA1c greater than or equal to 7.0% and less than or equal to 9.5%; or is currently on AHA monotherapy or low-dose oral combination therapy (i.e., less than or equal to 50% maximum labeled dose of each agent) and has a Visit 1/Screening Visit HbA1c greater than or equal to 6.5% and less than or equal to 9.0%

Exclusion Criteria:

  • Has a history of type 1 diabetes mellitus or a history of ketoacidosis
  • Has been on any investigational or approved glucagon-like peptide-1 (GLP-1) analogue (such as exenatide, liraglutide, etc.), any investigational or approved dipeptidyl peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.) or a peroxisome proliferator-activated receptor (PPAR) gamma agonist agent (such as rosiglitazone, pioglitazone, etc.) within 12 weeks of Visit 1
  • Required insulin within the prior 12 weeks
  • Has a hypersensitivity or contraindication to any sulfonylurea medication (such as glimepiride, glipizide, etc.), DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.), or biguanide medication (such as metformin, etc.)
  • Has inadequately controlled hypertension
  • Has cirrhosis or active live disease
  • Has severe cardiac conditions
  • Is obese
  • Has human immunodeficiency virus (HIV)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993187

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: NCT00993187     History of Changes
Other Study ID Numbers: 0431A-202, 2009_672
Study First Received: October 9, 2009
Last Updated: November 11, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014