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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830076
• Other study ID #: 0431-110
• Secondary ID: 2009_521
• Status: Completed
• Phase: Phase 1
• First received: January 26, 2009
• Last updated: August 3, 2015
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sitagliptin phosphate
Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.
• metformin hydrochloride
Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washout between treatment periods.
• Comparator: placebo sitagliptin
Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.
• Comparator: placebo metformin
Placebo to metformin 500 mg tablet in the morning and evening on Day 1 and two placebo to metformin 500 mg tablets (1000 mg total dose) in the morning of Day 2. There will be a 7-day wash out between treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations	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.	6 hours postdose (4 hours postmeal) on Day 2	No
Secondary	ß-cell Sensitivity	ß-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.	6 hour post-dose (4 hour postmeal) on Day 2	No
Secondary	Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations	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.	6 hours postdose (4 hours postmeal) on Day 2	No