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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00830076
First received: January 26, 2009
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: sitagliptin phosphate
Drug: metformin hydrochloride
Drug: Comparator: placebo sitagliptin
Drug: Comparator: placebo metformin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • β-cell Sensitivity [ Time Frame: 6 hour post-dose (4 hour postmeal) on Day 2 ] [ Designated as safety issue: No ]
    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.

  • Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations [ Time Frame: 6 hours postdose (4 hours postmeal) on Day 2 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin + placebo metformin 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.
Other Name: Januvia
Drug: 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.
Experimental: Metformin + placebo sitagliptin Drug: 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.
Other Name: Glucophage
Drug: 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.
Experimental: Sitagliptin + metformin
Co-administration of sitagliptin and metformin
 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.
Other Name: Januvia
Drug: 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.
Other Name: Glucophage
Placebo Comparator: Placebo sitagliptin + placebo metformin
Co-administration of placebo to sitagliptin and placebo to metformin
 Drug: 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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830076

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00830076     History of Changes
Other Study ID Numbers: MK-0431-110, 2009_521
Study First Received: January 26, 2009
Results First Received: September 29, 2011
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Incretins
Hypoglycemic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 18, 2012