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Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

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: NCT00601250
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : June 7, 2011
Last Update Posted : January 28, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Brief Summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: linagliptin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 701 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
Study Start Date : January 2008
Actual Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Linagliptin
Patients receive linagliptin 5 mg tablets once daily
 Drug: linagliptin
Patients receive linagliptin 5 mg tablets once daily
Placebo Comparator: Placebo
Patients receive placebo tablets matching linagliptin 5 mg tablets once daily
 Drug: linagliptin
Patients receive linagliptin 5 mg tablets once daily


Outcome Measures
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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 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.

  6. 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.

  7. 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.

  8. 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 7.0% 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 >= 7.0%. Only patients with baseline HbA1c >= 7%

  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 7.0% 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 >= 7.0%.

  10. 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 >= 6.5%. Only patients with baseline HbA1c >= 6.5%

  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 >= 6.5%.

  12. Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24 [ Time Frame: Baseline and week 24 ]
    The percentage of patients with an HbA1c reduction from baseline >= 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%.

  13. Adjusted Means for 2h Post Prandial Blood 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 PPG and previous anti-diabetic medication.

  14. 2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and week 24 ]
    This change from baseline reflects the Week 24 (2h PPG - FPG) minus the baseline (2h PPG - FPG). Means are treatment adjusted for baseline HbA1c, baseline 2h PPG increment over FPG and previous anti-diabetic medication.


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

Inclusion criteria:

  1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
  2. Diagnosis of type 2 diabetes prior to informed consent

  3. Glycosylated haemoglobin A1 (HbA1c)at screening:

    For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%

  4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
  5. Age 18 -80 years
  6. BMI (Body Mass Index) less than 40 kg/m2
  7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion criteria:

  1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  2. Impaired hepatic function
  3. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
  4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
  5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
  6. Treatment with insulin within 3 months prior to informed consent
  7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
  8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
  9. Participation in another trial with an investigational drug within 2 months prior to informed consent

  10. Pre-menopausal women who:

    • are nursing or pregnant,
    • or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
  11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
  12. Renal failure or renal impairment
  13. Unstable or acute congestive heart failure
  14. Acute or chronic metabolic acidosis (present in patient history)
  15. Hereditary galactose intolerance
Contacts and Locations
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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): NCT00601250


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00601250    
Other Study ID Numbers: 1218.17
2007-002457-24 ( EudraCT Number: EudraCT )
First Posted: January 28, 2008    Key Record Dates
Results First Posted: June 7, 2011
Last Update Posted: January 28, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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