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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: metformin hydrochloride; Drug: Comparator: placebo sitagliptin; Drug: sitagliptin phosphate; Drug: Comparator: placebo metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830076

2009_521

0431-110

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 4 patient groups, including a placebo group

Sitagliptin + placebo metformin

Experimental group

Treatment:

Drug: Comparator: placebo metformin

Drug: sitagliptin phosphate

Metformin + placebo sitagliptin

Experimental group

Treatment:

Drug: Comparator: placebo sitagliptin

Drug: metformin hydrochloride

Sitagliptin + metformin

Experimental group

Description:

Co-administration of sitagliptin and metformin

Treatment:

Drug: sitagliptin phosphate

Drug: metformin hydrochloride

Placebo sitagliptin + placebo metformin

Placebo Comparator group

Description:

Co-administration of placebo to sitagliptin and placebo to metformin

Treatment:

Drug: Comparator: placebo sitagliptin

Drug: Comparator: placebo metformin