search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate
metformin hydrochloride
Comparator: placebo sitagliptin
Comparator: placebo metformin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Sitagliptin + placebo metformin

    Metformin + placebo sitagliptin

    Sitagliptin + metformin

    Placebo sitagliptin + placebo metformin

    Arm Description

    Co-administration of sitagliptin and metformin

    Co-administration of placebo to sitagliptin and placebo to metformin

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    β-cell Sensitivity
    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
    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.

    Full Information

    First Posted
    January 26, 2009
    Last Updated
    April 10, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00830076
    Brief Title
    A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
    Official Title
    A Study to Assess the Effects of Co-Administration of Sitagliptin and Metformin on Incretin Hormone Concentrations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2, 2008 (Actual)
    Primary Completion Date
    April 30, 2009 (Actual)
    Study Completion Date
    May 14, 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sitagliptin + placebo metformin
    Arm Type
    Experimental
    Arm Title
    Metformin + placebo sitagliptin
    Arm Type
    Experimental
    Arm Title
    Sitagliptin + metformin
    Arm Type
    Experimental
    Arm Description
    Co-administration of sitagliptin and metformin
    Arm Title
    Placebo sitagliptin + placebo metformin
    Arm Type
    Placebo Comparator
    Arm Description
    Co-administration of placebo to sitagliptin and placebo to metformin
    Intervention Type
    Drug
    Intervention Name(s)
    sitagliptin phosphate
    Other Intervention Name(s)
    Januvia
    Intervention Description
    Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    metformin hydrochloride
    Other Intervention Name(s)
    Glucophage
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo sitagliptin
    Intervention Description
    Placebo to sitagliptin 100 mg in the morning on Days 1 and 2. There will be a 7-day washout between treatment periods.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: placebo metformin
    Intervention Description
    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 Outcome Measure Information:
    Title
    Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations
    Description
    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.
    Time Frame
    6 hours postdose (4 hours postmeal) on Day 2
    Secondary Outcome Measure Information:
    Title
    β-cell Sensitivity
    Description
    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.
    Time Frame
    6 hour post-dose (4 hour postmeal) on Day 2
    Title
    Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations
    Description
    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.
    Time Frame
    6 hours postdose (4 hours postmeal) on Day 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs