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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00830076
First received: January 26, 2009
Last updated: September 29, 2011
Last verified: September 2011

January 26, 2009
September 29, 2011
December 2008
April 2009   (final data collection date for primary outcome measure)
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.
Post-prandial glucagon-like peptide-1 (GLP-1) concentrations [ Time Frame: 6 hours postdose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00830076 on ClinicalTrials.gov Archive Site
  • 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.
Post-prandial C-peptide and insulin concentrations [ Time Frame: 6 hours postdose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • 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.
  • Experimental: Sitagliptin + placebo metformin
    Interventions:
    • Drug: sitagliptin phosphate
    • Drug: Comparator: placebo metformin
  • Experimental: Metformin + placebo sitagliptin
    Interventions:
    • Drug: metformin hydrochloride
    • Drug: Comparator: placebo sitagliptin
  • Experimental: Sitagliptin + metformin
    Co-administration of sitagliptin and metformin
    Interventions:
    • Drug: sitagliptin phosphate
    • Drug: metformin hydrochloride
  • Placebo Comparator: Placebo sitagliptin + placebo metformin
    Co-administration of placebo to sitagliptin and placebo to metformin
    Interventions:
    • Drug: Comparator: placebo sitagliptin
    • Drug: Comparator: placebo metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00830076
MK-0431-110, 2009_521
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP