We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00798161
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : August 4, 2011
Last Update Posted : January 28, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: BI 1356 Drug: BI 1356 + metformin Drug: Bi 1356 + metformin Drug: Metformin Drug: metformin Drug: matching placebo Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 857 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control
Study Start Date : December 2008
Actual Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: BI 1356 + metformin
BI 1356 low dose + metformin 500 mg, twice daily
 Drug: BI 1356 + metformin
BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily
Placebo Comparator: matching placebo
matching placebo
 Drug: matching placebo
matching placebo
Experimental: BI 1356+ Metformin
BI 1356 low dose + metformin 1000 mg, twice daily
 Drug: Bi 1356 + metformin
BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily
Active Comparator: Metformin
Metformin 500 mg, twice daily
 Drug: Metformin
Metformin 500 mg tablet, twice daily
Active Comparator: metformin
Metformin 1000 mg, twice daily
 Drug: metformin
metformin 1000 mg tablet, twice daily
Experimental: BI 1356
BI 1356 high dose, once daily
 Drug: BI 1356
BI 1356 high dose tablet, once daily


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HbA1c Change From Baseline at Week 24 [ Time Frame: Baseline and week 24 ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.


Secondary Outcome Measures :
  1. HbA1c Change From Baseline at Week 6 [ Time Frame: Baseline and week 6 ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  2. HbA1c Change From Baseline at Week 12 [ Time Frame: Baseline and week 12 ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  3. HbA1c Change From Baseline at Week 18 [ Time Frame: Baseline and week 18 ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  4. FPG Change From Baseline at Week 24 [ Time Frame: Baseline and week 24 ]
    This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  5. FPG Change From Baseline at Week 2 [ Time Frame: Baseline and week 2 ]
    This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  6. FPG Change From Baseline at Week 6 [ Time Frame: Baseline and week 6 ]
    This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  7. FPG Change From Baseline at Week 12 [ Time Frame: Baseline and 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.

  8. FPG Change From Baseline at Week 18 [ Time Frame: Baseline and week 18 ]
    This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

  9. Percentage of Patients With HbA1c <7.0% at Week 24 [ Time Frame: Baseline and Week 24 ]
    The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.

  10. Percentage of Patients With HbA1c<7.0 at Week 24 [ Time Frame: Baseline and Week 24 ]
    The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.

  11. Percentage of Patients With HbA1c <6.5% at Week 24 [ Time Frame: Baseline and Week 24 ]
    The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =< 6.5%

  12. Percentage of Patients With HbA1c < 6.5% at Week 24 [ Time Frame: Baseline and Week 24 ]
    The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%

  13. Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 [ Time Frame: Baseline and week 24 ]
    The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.

  14. Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24 [ Time Frame: Baseline and week 24 ]
    This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.

  15. HbA1c Change From Baseline at Week 24 for Open-label Patients [ Time Frame: Baseline and week 24 ]
    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.

  16. FPG Change From Baseline at Week 24 for Open-label Patients [ Time Frame: Baseline and week 24 ]
    This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.

  17. Use of Rescue Therapy [ Time Frame: 24 weeks ]
    The use of rescue therapy (SUs, thiazolidinediones [TZDs], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm

Exclusion criteria:

Myocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798161


Locations
Show Show 138 study locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00798161    
Other Study ID Numbers: 1218.46
2008-001640-40 ( EudraCT Number: EudraCT )
First Posted: November 25, 2008    Key Record Dates
Results First Posted: August 4, 2011
Last Update Posted: January 28, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Linagliptin
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action