A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: sitagliptin phosphate; Drug: metformin hydrochloride

• Registration Number: NCT00830076
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-02
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2009-04-30
• Study Completion: 2009-05-14
• Results First Submitted: 2011-09-29
• Results First Submitted QC: 2011-09-29
• Results First Posted: 2011-11-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Female subjects must have a negative pregnancy test
• Subject has type 2 diabetes and is not currently receiving treatment with an oral AHA agent, has not received such treatment for 3 months prior to study, and/or has not received more than 4 total weeks treatment with an oral AHA agent for 12 to 18 months prior to the study
• Subject is a nonsmoker or has not smoked and/or used nicotine for at least 6 months

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Exclusion Criteria

• Subject has a history of stroke, seizures, or major neurological disorders
• Female subject is breastfeeding
• Subject cannot refrain from use of any prescription or non-prescription drugs beginning 2 weeks prior to first dose of study drug
• Subject consumes more than 3 alcoholic beverages per day
• Subject consumes more than 6 caffeinated beverages per day
• Subject has had major surgery, or has donated or lost 1 unit of blood within 4 weeks of screening
• Subject has a history of cancer, except certain skin or cervical cancer or other cancers treated more than 10 years prior to screening
• Subject has a history of multiple and/or severe allergies or intolerance to drugs or food

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sitagliptin + placebo metformin	sitagliptin phosphate	-
Sitagliptin + metformin	sitagliptin phosphate	Co-administration of sitagliptin and metformin
Sitagliptin + metformin	metformin hydrochloride	Co-administration of sitagliptin and metformin
Metformin + placebo sitagliptin	metformin hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations	6 hours postdose (4 hours postmeal) on Day 2	Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period.

Secondary Outcome Measures

Name	Time	Method
Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations	6 hours postdose (4 hours postmeal) on Day 2	Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period.
β-cell Sensitivity	6 hour post-dose (4 hour postmeal) on Day 2	β-cell sensitivity was defined as the incremental post-prandial; 4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC.