Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments mk-3102, matching placebo to mk-3012, glimepiride, metformin
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date October 2012
End date December 2014
Trial size 300 participants
Trial identifier NCT01704261, 2012-002612-10, 3102-022

Summary

This study will examine the safety and efficacy of the addition of MK-3102 in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and sulfonylurea. The primary hypothesis is that after 24 weeks, the addition of treatment with MK-3102 provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
MK-3102 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
mk-3102
MK-3102 25 mg capsule administered orally once a week
glimepiride Amaryl®
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
metformin Fortamet®
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
(Placebo Comparator)
Matching placebo to MK-3102 capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
matching placebo to mk-3012
Matching placebo to MK-3102 capsule administered orally once a week
glimepiride Amaryl®
Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
metformin Fortamet®
Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg

Primary Outcomes

Measure
Change from baseline in hemoglobin A1c (A1C)
time frame: Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event
time frame: Up to Week 27
Percentage of Participants Who Discontinued from the Study Due to an Adverse Event
time frame: Up to Week 24

Secondary Outcomes

Measure
Change from baseline in fasting plasma glucose (FPG)
time frame: Baseline and Week 24
Percentage of participants attaining A1C glycemic goals of <7% and <6.5%
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with type 2 diabetes mellitus - Currently taking stable doses of metformin (>=1500 mg/day) and sulfonylurea - Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug Exclusion Criteria: - History of type 1 diabetes mellitus or a history of ketoacidosis - Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with MK-3102 at any time prior to study participation. - History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor - On a weight loss program and is not in the maintenance phase; or has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to study participation. - Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted) - Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks - Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease - Human immunodeficiency virus (HIV) - New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within the past 3 months - Poorly controlled hypertension - History of malignancy <=5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer - Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - Pregnant or breast feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug - Current user of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes >2 alcoholic drinks per day or >14 drinks per week, or engages in binge drinking - Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or during the study

Additional Information

Official title A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..