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

October 9, 2009
November 11, 2013
May 2010
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00993187 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in fasting plasma glucose (FPG) at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: Yes ]
  • Number of patients with hypoglycemic events [ Time Frame: up to Week 30 ] [ Designated as safety issue: No ]
  • The change from baseline in body weight at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]
  • Number of patients with HbA1c < 7.0% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus (MK-0431A-202 AM2)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Non-insulin-dependent
  • 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: 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
  • Drug: Matching placebo to glimepiride
    Matching placebo to glimepiride tablet orally daily for 30 weeks
  • Experimental: MK-0431A
    MK-0431A up to 50/1000 mg twice daily (BID) plus matching placebo to glimepiride daily for 30 weeks
    Interventions:
    • Drug: MK-0431A
    • Drug: Matching placebo to glimepiride
  • Active Comparator: Glimepiride
    Glimepiride up to 6 mg daily plus matching placebo to MK-0431A BID for 30 weeks
    Interventions:
    • Drug: Comparator: Glimepiride
    • Drug: Matching placebo to MK-0431A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
292
October 2013
October 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00993187
0431A-202, 2009_672
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

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