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Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Linagliptin
Linagliptin
Linagliptin
Placebo
Glimepiride
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Inclusion_Criteria: Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug HbA1c 7.5 10.0% at screening for patients treated with metformin alone HbA1c 7.5 10.0% at beginning of the placebo run-in phase Age > 21 and < 75 years MI > 25 and < 40 kg/m2 (Body Mass Index) Exclusion criteria: Exclusion_Criteria: Clinically relevant cardiovascular disease Impaired hepatic function Renal insufficiency or impaired renal function Treatment with rosiglitazone or pioglitazone within 6 months prior to screening Treatment with insulin within 3 months prior to screening

Sites / Locations

  • 1218.6.3304A Boehringer Ingelheim Investigational Site
  • 1218.6.3305A Euraxi Pharma
  • 1218.6.3302A Boehringer Ingelheim Investigational Site
  • 1218.6.3303A Boehringer Ingelheim Investigational Site
  • 1218.6.3301A Boehringer Ingelheim Investigational Site
  • 1218.6.49007 Boehringer Ingelheim Investigational Site
  • 1218.6.49013 Boehringer Ingelheim Investigational Site
  • 1218.6.49008 Boehringer Ingelheim Investigational Site
  • 1218.6.49009 Boehringer Ingelheim Investigational Site
  • 1218.6.49014 Boehringer Ingelheim Investigational Site
  • 1218.6.49012 Boehringer Ingelheim Investigational Site
  • 1218.6.49001 Boehringer Ingelheim Investigational Site
  • 1218.6.49005 Boehringer Ingelheim Investigational Site
  • 1218.6.49017 Boehringer Ingelheim Investigational Site
  • 1218.6.49002 Boehringer Ingelheim Investigational Site
  • 1218.6.49011 Boehringer Ingelheim Investigational Site
  • 1218.6.49010 Boehringer Ingelheim Investigational Site
  • 1218.6.49015 Boehringer Ingelheim Investigational Site
  • 1218.6.49016 Boehringer Ingelheim Investigational Site
  • 1218.6.49003 Boehringer Ingelheim Investigational Site
  • 1218.6.42103 Boehringer Ingelheim Investigational Site
  • 1218.6.42104 Boehringer Ingelheim Investigational Site
  • 1218.6.42105 Boehringer Ingelheim Investigational Site
  • 1218.6.42101 Boehringer Ingelheim Investigational Site
  • 1218.6.46003 Boehringer Ingelheim Investigational Site
  • 1218.6.46001 Boehringer Ingelheim Investigational Site
  • 1218.6.46002 Boehringer Ingelheim Investigational Site
  • 1218.6.46004 Boehringer Ingelheim Investigational Site
  • 1218.6.38002 Boehringer Ingelheim Investigational Site
  • 1218.6.38001 Boehringer Ingelheim Investigational Site
  • 1218.6.38003 Boehringer Ingelheim Investigational Site
  • 1218.6.38005 Boehringer Ingelheim Investigational Site
  • 1218.6.44012 Boehringer Ingelheim Investigational Site
  • 1218.6.44004 Boehringer Ingelheim Investigational Site
  • 1218.6.44002 Boehringer Ingelheim Investigational Site
  • 1218.6.44003 Boehringer Ingelheim Investigational Site
  • 1218.6.44013 Boehringer Ingelheim Investigational Site
  • 1218.6.44016 Boehringer Ingelheim Investigational Site
  • 1218.6.44007 Boehringer Ingelheim Investigational Site
  • 1218.6.44006 Boehringer Ingelheim Investigational Site
  • 1218.6.44005 Boehringer Ingelheim Investigational Site
  • 1218.6.44015 Boehringer Ingelheim Investigational Site
  • 1218.6.44008 Boehringer Ingelheim Investigational Site
  • 1218.6.44017 Boehringer Ingelheim Investigational Site
  • 1218.6.44001 Boehringer Ingelheim Investigational Site
  • 1218.6.44018 Boehringer Ingelheim Investigational Site
  • 1218.6.44009 Boehringer Ingelheim Investigational Site
  • 1218.6.44019 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Linagliptin low dose

Linagliptin medium dose

Linagliptin high dose

Placebo

Glimepiride

Arm Description

Patients receive Linagliptin low dose tablets once daily

Patients receive Linagliptin medium dose tablets once daily

Patients receive Linagliptin high dose tablets once daily

Patients receive tablets identical to those containing Linagliptin low, medium and high dose

Patients receive Glimepiride tablets once daily

Outcomes

Primary Outcome Measures

HbA1c Change From Baseline at Week 12
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.

Secondary Outcome Measures

Percentage of Patients With HbA1c<=7.0% at Week 12
Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.
Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Full Information

First Posted
March 31, 2006
Last Updated
June 24, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00309608
Brief Title
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Official Title
A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

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
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linagliptin low dose
Arm Type
Experimental
Arm Description
Patients receive Linagliptin low dose tablets once daily
Arm Title
Linagliptin medium dose
Arm Type
Experimental
Arm Description
Patients receive Linagliptin medium dose tablets once daily
Arm Title
Linagliptin high dose
Arm Type
Experimental
Arm Description
Patients receive Linagliptin high dose tablets once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive tablets identical to those containing Linagliptin low, medium and high dose
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
Patients receive Glimepiride tablets once daily
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Description
Linagliptin medium dose tablet once daily
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Description
Linagliptin high dose tablet once daily
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Description
Linagliptin low dose tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets once daily
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Intervention Description
Glimepiride tablets once daily
Primary Outcome Measure Information:
Title
HbA1c Change From Baseline at Week 12
Description
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Percentage of Patients With HbA1c<=7.0% at Week 12
Description
Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.
Time Frame
week 12
Title
Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12
Description
This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Time Frame
Baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Inclusion_Criteria: Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug HbA1c 7.5 10.0% at screening for patients treated with metformin alone HbA1c 7.5 10.0% at beginning of the placebo run-in phase Age > 21 and < 75 years MI > 25 and < 40 kg/m2 (Body Mass Index) Exclusion criteria: Exclusion_Criteria: Clinically relevant cardiovascular disease Impaired hepatic function Renal insufficiency or impaired renal function Treatment with rosiglitazone or pioglitazone within 6 months prior to screening Treatment with insulin within 3 months prior to screening
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
1218.6.3304A Boehringer Ingelheim Investigational Site
City
Joue les Tours
Country
France
Facility Name
1218.6.3305A Euraxi Pharma
City
Joue les Tours
Country
France
Facility Name
1218.6.3302A Boehringer Ingelheim Investigational Site
City
Joué les Tours
Country
France
Facility Name
1218.6.3303A Boehringer Ingelheim Investigational Site
City
Joué Les Tours
Country
France
Facility Name
1218.6.3301A Boehringer Ingelheim Investigational Site
City
Paris cedex 13
Country
France
Facility Name
1218.6.49007 Boehringer Ingelheim Investigational Site
City
Aschaffenburg
Country
Germany
Facility Name
1218.6.49013 Boehringer Ingelheim Investigational Site
City
Bosenheim
Country
Germany
Facility Name
1218.6.49008 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
1218.6.49009 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1218.6.49014 Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
1218.6.49012 Boehringer Ingelheim Investigational Site
City
Immenstadt
Country
Germany
Facility Name
1218.6.49001 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1218.6.49005 Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
1218.6.49017 Boehringer Ingelheim Investigational Site
City
Offenbach a. M.
Country
Germany
Facility Name
1218.6.49002 Boehringer Ingelheim Investigational Site
City
Saarbrücken
Country
Germany
Facility Name
1218.6.49011 Boehringer Ingelheim Investigational Site
City
Sinsheim
Country
Germany
Facility Name
1218.6.49010 Boehringer Ingelheim Investigational Site
City
St. Ingbert/Oberwürzbach
Country
Germany
Facility Name
1218.6.49015 Boehringer Ingelheim Investigational Site
City
Sulzbach-Rosenberg
Country
Germany
Facility Name
1218.6.49016 Boehringer Ingelheim Investigational Site
City
Wangen
Country
Germany
Facility Name
1218.6.49003 Boehringer Ingelheim Investigational Site
City
Würzburg
Country
Germany
Facility Name
1218.6.42103 Boehringer Ingelheim Investigational Site
City
Banska Bystrica
Country
Slovakia
Facility Name
1218.6.42104 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
1218.6.42105 Boehringer Ingelheim Investigational Site
City
Bratislava
Country
Slovakia
Facility Name
1218.6.42101 Boehringer Ingelheim Investigational Site
City
Nove Mesto nad Vahom
Country
Slovakia
Facility Name
1218.6.46003 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1218.6.46001 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
1218.6.46002 Boehringer Ingelheim Investigational Site
City
Uddevalla
Country
Sweden
Facility Name
1218.6.46004 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1218.6.38002 Boehringer Ingelheim Investigational Site
City
Dnyepropetrovsk
Country
Ukraine
Facility Name
1218.6.38001 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1218.6.38003 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1218.6.38005 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1218.6.44012 Boehringer Ingelheim Investigational Site
City
Ashford
Country
United Kingdom
Facility Name
1218.6.44004 Boehringer Ingelheim Investigational Site
City
Baillieston, Glasgow
Country
United Kingdom
Facility Name
1218.6.44002 Boehringer Ingelheim Investigational Site
City
Bath
Country
United Kingdom
Facility Name
1218.6.44003 Boehringer Ingelheim Investigational Site
City
Birmingham
Country
United Kingdom
Facility Name
1218.6.44013 Boehringer Ingelheim Investigational Site
City
Camberley
Country
United Kingdom
Facility Name
1218.6.44016 Boehringer Ingelheim Investigational Site
City
Chorley
Country
United Kingdom
Facility Name
1218.6.44007 Boehringer Ingelheim Investigational Site
City
Dundee
Country
United Kingdom
Facility Name
1218.6.44006 Boehringer Ingelheim Investigational Site
City
Exeter
Country
United Kingdom
Facility Name
1218.6.44005 Boehringer Ingelheim Investigational Site
City
Gillingham
Country
United Kingdom
Facility Name
1218.6.44015 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
1218.6.44008 Boehringer Ingelheim Investigational Site
City
Guildford
Country
United Kingdom
Facility Name
1218.6.44017 Boehringer Ingelheim Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
1218.6.44001 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1218.6.44018 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1218.6.44009 Boehringer Ingelheim Investigational Site
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
1218.6.44019 Boehringer Ingelheim Investigational Site
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.6_U08-1056-03-DS.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.6_Literature.pdf
Description
Related Info

Learn more about this trial

Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

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