Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Linagliptin/Metformin Combo; Drug: Metformin Single Tablet; Drug: Linagliptin Single Tablet

• Registration Number: NCT01383356
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-12-18
• Results First Submitted QC: 2012-12-18
• Results First Posted: 2013-01-24
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Linagliptin/Metformin medium dosecombo	Linagliptin/Metformin Combo	patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily
Linagliptin plus Metformin medium dose	Metformin Single Tablet	patient to receive two individual tablets: Linagliptin and Metformin (medium dose)
Linagliptin plus Metformin medium dose	Linagliptin Single Tablet	patient to receive two individual tablets: Linagliptin and Metformin (medium dose)

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	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	Maximum measured concentration of metformin in plasma, per period.
Area Under the Curve 0 to Last Measurable Value (AUC0-t)	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	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

Name	Time	Method
Area Under the Curve 0 to Inf (AUC0-inf)	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	AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.

Trial Locations

Locations (1)

1288.19.1 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada