Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
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|ClinicalTrials.gov Identifier: NCT00993187|
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : September 15, 2014
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||May 4, 2010|
|Actual Primary Completion Date :||October 29, 2013|
|Actual Study Completion Date :||October 29, 2013|
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
- Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30 [ Time Frame: Baseline and 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).
- Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Up to 32 weeks ]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 ]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.
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 [ Time Frame: Baseline and 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).
- Percentage of Participants With One or More Episodes of Hypoglycemia [ Time Frame: Up to Week 30 ]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 ]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 ]HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993187
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|