Phase 4
Completed N=292
Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
Source: ClinicalTrials.gov NCT00993187 ↗Enrolled (actual)
292
Serious AEs
5.9%
Results posted
Sep 2014
Primary outcomePrimary: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30 — -1.5; -0.7 Percent of total hemoglobin — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30 |
-1.5; -0.7 | <0.001 sig |
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event (AE) |
88; 101 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an Adverse Event |
8; 8 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 |
-47.0; -23.5 | <0.001 sig |
| SECONDARY Percentage of Participants With One or More Episodes of Hypoglycemia |
5.5; 20.1 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 30 |
-0.83; 0.90 | <0.001 sig |
| SECONDARY Percentage of Participants With HbA1C < 7.0% at Week 30 |
81.2; 40.1 | <0.001 sig |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00993187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.