The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients

June 18, 2014 updated by: Boehringer Ingelheim

A 4-week, Randomized, Double Blind, Double Dummy, Placebo Controlled, Parallel Group Study Comparing the Influence of BI 1356 (5 mg) and Sitagliptin (100 mg) Administered Orally Once Daily on Various Biomarkers in Type 2 Diabetic Patients

The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • 1218.37.49003 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1218.37.49002 Boehringer Ingelheim Investigational Site
      • Neuss, Germany
        • 1218.37.49001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug
  • Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in

Exclusion criteria:

  • Myocardial infarction, stroke or transient ischemic attack "TIA" within 6 months prior to informed consent
  • Impaired hepatic function
  • Renal insufficiency with a creatinine clearance < 50 mL/min
  • Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin.
Drug: Placebo (linagliptin)
once daily for 28 days
Drug: Placebo (sitagliptin)
once daily for 28 days
Experimental: Linagliptin
Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin.
Drug: Placebo (sitagliptin)
once daily for 28 days
Drug: Linagliptin
5mg once daily for 28 days
Active Comparator: Sitagliptin
Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.
Drug: Placebo (linagliptin)
once daily for 28 days
Drug: Sitagliptin
100 mg once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weighted Mean Glucose (WMG) Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication, and baseline WMG.
Baseline and day 28
GLP-1 (Glucagon Like Peptide 1) AUEC (0-2h) (Area Under Effect Curve) Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.
Baseline and day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose (FPG) Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.
Baseline and day 28
Plasma Glucose Area Under Effect Curve (AUEC) (0-3h) Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 Glucose AUEC (0-3h) value minus the baseline Glucose AUEC (0-3h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline plasma glucose AUEC (0-3h).
Baseline and day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Sensitivity Analysis of the WMG Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 WMG value minus the baseline WMG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline WMG.
Baseline and day 28
Exploratory Sensitivity Analysis of GLP-1 AUEC (0-2h) Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 GLP-1 AUEC (0-2h) value minus the baseline GLP-1 AUEC (0-2h) value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline GLP-1.
Baseline and day 28
Exploratory Sensitivity Analysis of FPG Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.
Baseline and day 28
Exploratory Sensitivity Analysis of Plasma Glucose AUEC (0-3h) Change From Baseline at Day 28
Time Frame: Baseline and day 28
The change from baseline reflects the day 28 FPG value minus the baseline FPG value. Means are treatment adjusted for baseline HbA1c, previous anti-diabetic medication and baseline FPG.
Baseline and day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

July 15, 2008

First Submitted That Met QC Criteria

July 15, 2008

First Posted (Estimate)

July 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2014

Last Update Submitted That Met QC Criteria

June 18, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.37
  • 2007-007865-19 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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