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 is ongoing, but not recruiting participants.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00993187
First received: October 9, 2009
Last updated: April 1, 2013
Last verified: April 2013
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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:
Drug Information available for:
Metformin
Metformin hydrochloride
Glimepiride
Sitagliptin
Sitagliptin phosphate
Janumet
U.S. FDA Resources
Further study details as provided by Merck:
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 ]
| Estimated Enrollment: | 278 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated 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 More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00993187 History of Changes |
| Other Study ID Numbers: | 0431A-202, 2009_672 |
| Study First Received: | October 9, 2009 |
| Last Updated: | April 1, 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 May 16, 2013