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

NCT00830076 | Completed Phase 1 Results

• 2 other identifiers: 0431-1102009_521
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• β-cell Sensitivity

  6 hour post-dose (4 hour postmeal) on Day 2

• Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations

  6 hours postdose (4 hours postmeal) on Day 2

Study Arms (4)

Sitagliptin + placebo metformin

EXPERIMENTAL

Drug: sitagliptin phosphate; Drug: Comparator: placebo metformin

Metformin + placebo sitagliptin

EXPERIMENTAL

Drug: metformin hydrochloride; Drug: Comparator: placebo sitagliptin

Sitagliptin + metformin

EXPERIMENTAL

Co-administration of sitagliptin and metformin

Drug: sitagliptin phosphate; Drug: metformin hydrochloride

Placebo sitagliptin + placebo metformin

PLACEBO COMPARATOR

Co-administration of placebo to sitagliptin and placebo to metformin

Drug: Comparator: placebo sitagliptin; Drug: Comparator: placebo metformin

Interventions

sitagliptin phosphate DRUG

Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.

Also known as: Januvia

Sitagliptin + metformin; Sitagliptin + placebo metformin

metformin hydrochloride DRUG

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.

Also known as: Glucophage

Metformin + placebo sitagliptin; Sitagliptin + metformin

Comparator: placebo sitagliptin DRUG

Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.

Metformin + placebo sitagliptin; Placebo sitagliptin + placebo metformin

Comparator: placebo metformin DRUG

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.

Placebo sitagliptin + placebo metformin; Sitagliptin + placebo metformin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 27, 2009
• Study Start: December 2, 2008
• Primary Completion: April 30, 2009
• Study Completion: May 14, 2009
• Last Updated: May 15, 2017
• Results First Posted: November 3, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share