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

Type 2 Diabetes (T2D) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088711
• Other study ID #: 3102-004
• Status: Completed
• Phase: Phase 1
• Start date: March 11, 2010
• Est. completion date: May 11, 2010

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 11, 2010
• Est. primary completion date: May 11, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes (T2D)

Intervention

Drug:
• Omarigliptin
Once-weekly 50 mg capsule
• Placebo
Once-weekly placebo capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Addy C, Tatosian D, Glasgow XS, Gendrano IN 3rd, Kauh E, Martucci A, Johnson-Levonas AO, Selverian D, Matthews CZ, Gutierrez M, Wagner JA, Aubrey Stoch S. Pharmacokinetic and Pharmacodynamic Effects of Multiple-dose Administration of Omarigliptin, a Once- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing an Adverse Event (AE)		Up to Day 36
Primary	Number of Participants Withdrawing From Study Therapy Due to an AE		Up to Day 22
Secondary	Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After 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.	168 hours post-dose on Day 15
Secondary	Percent Inhibition of DPP-4 After 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.	168 hours post dose on Day 22
Secondary	WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration	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.	Through 4 hours post dose on Day 21
Secondary	WAA Total GLP-1 Concentration	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.	Through 4 hours post dose on Day 21
Secondary	Plasma Glucose Concentration	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.	Through 4 hours post dose on Day 21