Clinical trial NCT00993187: Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-10-12
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30
timeFrame: Baseline and Week 30
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
timeFrame: Up to 32 weeks
measure: Number of Participants Who Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 30 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
timeFrame: Baseline and Week 30
measure: Percentage of Participants With One or More Episodes of Hypoglycemia
timeFrame: Up to Week 30
measure: Change From Baseline in Body Weight at Week 30
timeFrame: Baseline and Week 30
measure: Percentage of Participants With HbA1C < 7.0% at Week 30
timeFrame: Week 30
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kim SS, Kim IJ, Lee KJ, Park JH, Kim YI, Lee YS, Chung SC, Lee SJ. Efficacy and safety of sitagliptin/metformin fixed-dose combination compared with glimepiride in patients with type 2 diabetes: A multicenter randomized double-blind study. J Diabetes. 2017 Apr;9(4):412-422. doi: 10.1111/1753-0407.12432. Epub 2016 Aug 8.