Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026) - Full Text View

Purpose

This is a non-inferiority study comparing MK-3102 with Sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with MK-3102 is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: MK-3102 Drug: Sitagliptin Drug: Placebo to MK-3102 Drug: Placebo to Sitagliptin Drug: Open-label Metformin Drug: Open-label Glimepiride	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Glimepiride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Change from baseline in A1C at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Number of participants who experienced at least one adverse event [ Time Frame: Up to Week 27 ] [ Designated as safety issue: Yes ]
Number of participants who discontinued from the study due to an adverse event [ Time Frame: Up to Week 27 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Number of participants achieving an A1C goal <7.0% and < 6.5% after 24 weeks of treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]


Enrollment:	642
Study Start Date:	June 2013
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MK-3102 + metformin 25 mg capsule once a week for 24 weeks	Drug: MK-3102 MK-3102 - 25 mg capsule once a week for 24 weeks. Drug: Placebo to Sitagliptin Placebo once a day for 24 weeks Drug: Open-label Metformin Tablet(s) total daily dose of ≥1500 mg, once or twice a day Other Names: Fortamet® Glucophage® Glucophage® XR Glumetza® Riomet® Drug: Open-label Glimepiride Glimepiride tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy Other Names: Amaryl® Glimy
Active Comparator: Sitagliptin + metformin 100 mg tablet once a day for 24 weeks	Drug: Sitagliptin Sitagliptin - 100 mg tablet once a day for 24 weeks Drug: Placebo to MK-3102 Placebo once a week for 24 weeks Drug: Open-label Metformin Tablet(s) total daily dose of ≥1500 mg, once or twice a day Other Names: Fortamet® Glucophage® Glucophage® XR Glumetza® Riomet® Drug: Open-label Glimepiride Glimepiride tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy Other Names: Amaryl® Glimy

Arms

Assigned Interventions

Experimental: MK-3102 + metformin

25 mg capsule once a week for 24 weeks

Drug: MK-3102

MK-3102 - 25 mg capsule once a week for 24 weeks.

Drug: Placebo to Sitagliptin

Placebo once a day for 24 weeks

Drug: Open-label Metformin

Tablet(s) total daily dose of ≥1500 mg, once or twice a day

Other Names:

Fortamet®
Glucophage®
Glucophage® XR
Glumetza®
Riomet®

Drug: Open-label Glimepiride

Glimepiride tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy

Other Names:

Amaryl®
Glimy

Active Comparator: Sitagliptin + metformin

100 mg tablet once a day for 24 weeks

Drug: Sitagliptin

Sitagliptin - 100 mg tablet once a day for 24 weeks

Drug: Placebo to MK-3102

Placebo once a week for 24 weeks

Drug: Open-label Metformin

Tablet(s) total daily dose of ≥1500 mg, once or twice a day

Other Names:

Fortamet®
Glucophage®
Glucophage® XR
Glumetza®
Riomet®

Drug: Open-label Glimepiride

Glimepiride tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy

Other Names:

Amaryl®
Glimy

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus
Currently on a stable dose of metformin monotherapy (≥1500 mg per day) for at least 12 weeks prior to study participation
Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) 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
Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with MK-3102 at any time prior to signing informed consent
History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
Is currently participating in, or has participated in, a trial in which the participant received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial
History of intolerance, hypersensitivity, or any other contraindication to metformin or glimepiride
Is 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
Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
Is on or likely to require treatment ≥14 consecutive days or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks
Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days after the last dose of trial medication
History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gall bladder disease
Human immunodeficiency virus (HIV)
New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke, or transient ischemic attacks in 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
Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
Positive urine pregnancy test
Pregnant or breastfeeding, or is expecting to conceive during the study including 21 days following the last dose of blinded study drug
User of recreational or illicit drugs or has had a recent history of drug abuse
Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
Has donated blood products or has had phlebotomy of >300 mL within 8 weeks of study participation, or intends to donate blood products within the projected duration of the trial or has received, or is anticipated to receive, blood products within 12 weeks of study participation or within the projected duration of the trial

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01841697 History of Changes
Other Study ID Numbers:	3102-026, 2013-000059-42
Study First Received:	April 24, 2013
Last Updated:	January 30, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Glimepiride Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Glimepiride Metformin Sitagliptin Anti-Arrhythmia Agents Cardiovascular Agents Dipeptidyl-Peptidase IV Inhibitors Enzyme Inhibitors	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Immunologic Factors Immunosuppressive Agents Incretins Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015