Skip to main content
OpenTrials
Completed

NCT Number: NCT00830076

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Januvia

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.

Other names: Glucophage

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.

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.

Primary outcomes

  1. Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations

    Time frame: 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 outcomes

  1. β-cell Sensitivity

    Time frame: 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.

  2. Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2009
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.