Back to resultsComparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Metformin Single Tablet
Linagliptin/Metformin Combo
Linagliptin Single Tablet
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria:
1. Healthy male and female subjects.
Exclusion criteria:
1. Any relevant deviation from healthy conditions.
Sites / Locations
- 1288.19.1 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Linagliptin/Metformin medium dosecombo
Linagliptin plus Metformin medium dose
Arm Description
patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily
patient to receive two individual tablets: Linagliptin and Metformin (medium dose)
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration (Cmax)
Maximum measured concentration of metformin in plasma, per period.
Area Under the Curve 0 to Last Measurable Value (AUC0-t)
AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.
Secondary Outcome Measures
Area Under the Curve 0 to Inf (AUC0-inf)
AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01383356
Brief Title
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
Official Title
A Single Dose Comparative Bioavailability Study of Linagliptin/Metformin hydrochloride2.5mg/500mg Combination Tablets Versus Linagliptin 2.5mg Tablets Administered With Glucophage 500mg Tablets Under Fasting Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Linagliptin/Metformin medium dosecombo
Arm Type
Experimental
Arm Description
patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily
Arm Title
Linagliptin plus Metformin medium dose
Arm Type
Active Comparator
Arm Description
patient to receive two individual tablets: Linagliptin and Metformin (medium dose)
Intervention Type
Drug
Intervention Name(s)
Metformin Single Tablet
Intervention Description
Metformin medium doseTablet
Intervention Type
Drug
Intervention Name(s)
Linagliptin/Metformin Combo
Intervention Description
Fixed dose combination
Intervention Type
Drug
Intervention Name(s)
Linagliptin Single Tablet
Intervention Description
Linagliptin Single medium dose Tablet
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Description
Maximum measured concentration of metformin in plasma, per period.
Time Frame
Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
Title
Area Under the Curve 0 to Last Measurable Value (AUC0-t)
Description
AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.
Time Frame
Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
Secondary Outcome Measure Information:
Title
Area Under the Curve 0 to Inf (AUC0-inf)
Description
AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.
Time Frame
Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
1. Healthy male and female subjects.
Exclusion criteria:
1. Any relevant deviation from healthy conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1288.19.1 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1288/1288.19_U12-3212-01.pdf
Description
Related Info
Learn more about this trial
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet
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