Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993187
• Other study ID #: 0431A-202
• Secondary ID: 2009_672
• Status: Completed
• Phase: Phase 4
• Start date: May 4, 2010
• Est. completion date: October 29, 2013

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: October 29, 2013
• Est. primary completion date: October 29, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin/Metformin FDC
Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks
• Comparator: Glimepiride
Glimepiride tablet orally up to 6 mg daily for 30 Weeks
• Matching placebo to Sitagliptin/Metformin FDC
Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks
• Matching placebo to glimepiride
Matching placebo to glimepiride tablet orally daily for 30 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30	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).	Baseline and Week 30
Primary	Number of Participants Who Experienced at Least One Adverse Event (AE)	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.	Up to 32 weeks
Primary	Number of Participants Who Discontinued Study Drug Due to an Adverse Event	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.	Up to 30 weeks
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30	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).	Baseline and Week 30
Secondary	Percentage of Participants With One or More Episodes of Hypoglycemia	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.	Up to Week 30
Secondary	Change From Baseline in Body Weight at Week 30	Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)	Baseline and Week 30
Secondary	Percentage of Participants With HbA1C < 7.0% at Week 30	HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).	Week 30