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Completed

NCT Number: NCT01682759

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

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 omarigliptin 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

Treatment and study plan

Omarigliptin

Drug

Placebo to Omarigliptin

Drug

Glimepiride

Drug

Glimepiride (1 mg and/or 2 mg tablets). During the 54-week 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

Glimepiride Placebo

Drug

metformin

Drug

Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.

insulin glargine

Drug

Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.

Primary outcomes

  1. Change From Baseline in Hemoglobin A1C at Week 54

    Time frame: Baseline and Week 54

    Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.

  2. Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue

    Time frame: Up to Week 57

    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

  3. Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue

    Time frame: Up to Week 54

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose at Week 54

    Time frame: Baseline and Week 54

    Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).

  2. Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54

    Time frame: Week 54

    The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.

  3. Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue

    Time frame: Up to Week 54

    Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).

  4. Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue

    Time frame: Baseline and Week 54

  5. Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54

    Time frame: Week 54

    The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2012
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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