Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00993187
First received: October 9, 2009
Last updated: June 24, 2016
Last verified: June 2016
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Purpose
This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior reduction in HbA1c (mean change from baseline) compared to glimepiride.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Sitagliptin/Metformin FDC Drug: Comparator: Glimepiride Drug: Matching placebo to Sitagliptin/Metformin FDC 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:
MedlinePlus related topics:
Diabetes Type 2
Drug Information available for:
Metformin
Metformin hydrochloride
Glimepiride
Sitagliptin
Sitagliptin phosphate
Janumet
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).
- Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: Yes ]An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
- Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 30 weeks ] [ Designated as safety issue: Yes ]An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
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 ]Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).
- Percentage of Participants With One or More Episodes of Hypoglycemia [ Time Frame: Up to Week 30 ] [ Designated as safety issue: Yes ]Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.
- Change From Baseline in Body Weight at Week 30 [ Time Frame: Baseline and Week 30 ] [ Designated as safety issue: No ]Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)
- Percentage of Participants With HbA1C < 7.0% at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).
| 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: Sitagliptin/Metformin FDC
Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
|
Drug: Sitagliptin/Metformin FDC
Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) 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
Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
|
Drug: Comparator: Glimepiride
Glimepiride tablet orally up to 6 mg daily for 30 Weeks
Other Name: Amaryl®
Drug: Matching placebo to Sitagliptin/Metformin FDC
Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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 liver disease
- Has severe cardiac conditions
- Is obese
- Has human immunodeficiency virus (HIV)
Contacts and Locations
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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: NCT00993187
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
Publications:
| 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 |
| Results First Received: | September 8, 2014 |
| Last Updated: | June 24, 2016 |
| 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 Metformin Sitagliptin Phosphate 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 Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on September 28, 2016