A Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016 AM2) - Full Text View

Purpose

This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: MK-3102 Drug: MK-3102 Placebo Drug: Glimepiride Drug: Glimepiride Placebo Drug: Metformin Drug: Insulin Glargine	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 Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Metformin Metformin hydrochloride Insulin human Glimepiride Insulin glargine

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change from Baseline in Hemoglobin A1C at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to Week 57 ] [ Designated as safety issue: Yes ]
Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: Up to Week 54 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from Baseline in Fasting Plasma Glucose at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
Number of Participants Achieving a Hemoglobin A1C of <6.5% and <7.0% at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
Number of Participants with an Adverse Event of Symptomatic Hypoglycemia [ Time Frame: Up to Week 54 ] [ Designated as safety issue: Yes ]
Change in Body Weight from Baseline at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]

Estimated Enrollment:	680
Study Start Date:	September 2012
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MK-3102	Drug: MK-3102 MK-3102 (25 mg) will be administered in a blinded manner as one capsule once a week (q.w.) Drug: Glimepiride Placebo Placebos matching glimepiride 1 mg and/or 2 mg Drug: Metformin Open-label Drug: Insulin Glargine Insulin glargine can be used for rescue therapy, if glycemic control is not maintained.
Active Comparator: Glimepiride	Drug: MK-3102 Placebo Placebo matching MK-3102 (25 mg) Drug: Glimepiride Glimepiride (1 mg and/or 2 mg tablets). During the double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia. Other Names: AMARYL® GLIMY Drug: Metformin Open-label Drug: Insulin Glargine Insulin glargine can be used for rescue therapy, if glycemic control is not maintained.

Arms

Assigned Interventions

Experimental: MK-3102

Drug: MK-3102

MK-3102 (25 mg) will be administered in a blinded manner as one capsule once a week (q.w.)

Drug: Glimepiride Placebo

Placebos matching glimepiride 1 mg and/or 2 mg

Drug: Metformin

Open-label

Drug: Insulin Glargine

Insulin glargine can be used for rescue therapy, if glycemic control is not maintained.

Active Comparator: Glimepiride

Drug: MK-3102 Placebo

Placebo matching MK-3102 (25 mg)

Drug: Glimepiride

Glimepiride (1 mg and/or 2 mg tablets).

During the double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.

Other Names:

AMARYL®
GLIMY

Drug: Metformin

Open-label

Drug: Insulin Glargine

Insulin glargine can be used for rescue therapy, if glycemic control is not maintained.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosed with Type 2 diabetes mellitus
On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

Exclusion Criteria:

History of type 1 diabetes mellitus or a history of ketoacidosis
Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with MK-3102 at any time prior to signing informed consent
On a weight loss program and is not in the maintenance phase or has started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
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
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682759

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 43 Study Locations

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01682759 History of Changes
Other Study ID Numbers:	3102-016, MK-3102-016
Study First Received:	September 7, 2012
Last Updated:	April 24, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Metformin

Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013