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Completed

NCT Number: NCT01088711

Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)

This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.

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Key information

Conditions

Type 2 Diabetes (T2D) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • obese (body mass index [BMI] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
  • has been diagnosed with T2D (Panel B)
  • is not actively participating in a weight loss program

Exclusion criteria

  • has a history of clinically-significant disease (other than T2D)
  • has a history of cancer
  • has estimated creatinine clearance ≤60 mL/min
  • is unable to refrain from or anticipates the use of any prescription or non-prescription medication
  • consumes excessive amounts of alcohol or caffeine
  • has participated in a previous omarigliptin study

Treatment and study plan

Omarigliptin

Drug

Once-weekly 50 mg capsule

Other names: MK-3102

Placebo

Drug

Once-weekly placebo capsule

Primary outcomes

  1. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to Day 36

  2. Number of Participants Withdrawing From Study Therapy Due to an AE

    Time frame: Up to Day 22

Secondary outcomes

  1. Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15

    Time frame: 168 hours post-dose on Day 15

    Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.

  2. Percent Inhibition of DPP-4 After Day 22

    Time frame: 168 hours post dose on Day 22

    Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.

  3. WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration

    Time frame: Through 4 hours post dose on Day 21

    Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.

  4. WAA Total GLP-1 Concentration

    Time frame: Through 4 hours post dose on Day 21

    WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.

  5. Plasma Glucose Concentration

    Time frame: Through 4 hours post dose on Day 21

    Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 17, 2010
Registry last updated
Sep 10, 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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