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

NCT01383356 | Completed Phase 1 Results

• 1 other identifier: 1288.19
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax)

  Maximum measured concentration of metformin in plasma, per period.

  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

• 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.

  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 Outcomes (1)

• 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

Study Arms (2)

Linagliptin/Metformin medium dosecombo

EXPERIMENTAL

patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily

Drug: Linagliptin/Metformin Combo

Linagliptin plus Metformin medium dose

ACTIVE COMPARATOR

patient to receive two individual tablets: Linagliptin and Metformin (medium dose)

Drug: Metformin Single Tablet; Drug: Linagliptin Single Tablet

Interventions

Metformin Single Tablet DRUG

Metformin medium doseTablet

Linagliptin plus Metformin medium dose

Linagliptin/Metformin Combo DRUG

Fixed dose combination

Linagliptin/Metformin medium dosecombo

Linagliptin Single Tablet DRUG

Linagliptin Single medium dose Tablet

Linagliptin plus Metformin medium dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male and female subjects.

You may not qualify if:

• \. Any relevant deviation from healthy conditions.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1288.19.1 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 28, 2014
• Results First Posted: January 24, 2013

Record last verified: 2014-02

Locations

CA (1)