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Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone

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ClinicalTrials.gov Identifier: NCT00996658
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : March 26, 2013
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone
Study Start Date : October 2009
Actual Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Linagliptin
Linagliptin tablets once daily
Drug: Linagliptin
Linagliptin tablets once daily
Placebo Comparator: Placebo
Placebo tablets once daily
Drug: Placebo
Placebo matching linagliptin tablets once daily



Primary Outcome Measures :
  1. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks [ Time Frame: baseline, 24 weeks ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks [ Time Frame: baseline, 6 weeks ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  2. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks [ Time Frame: baseline, 12 weeks ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  3. Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks [ Time Frame: baseline, 18 weeks ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  4. Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks [ Time Frame: 24 weeks ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  5. Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks [ Time Frame: 24 weeks ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  6. Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks [ Time Frame: 24 weeks ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  7. Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks [ Time Frame: baseline, 24 weeks ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24

  8. Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks [ Time Frame: baseline, 6 weeks ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6

  9. Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks [ Time Frame: baseline, 12 weeks ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12

  10. Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks [ Time Frame: baseline, 18 weeks ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosis of diabetes mellitus prior to informed consent
  2. Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
  3. Glycosylated haemoglobin A1 >= 7.5% and <= 10%
  4. Age between 18 and less than 80
  5. - Body Mass index less or equal to 45

Exclusion criteria:

  1. Uncontrolled hyperglycaemia during run in period
  2. Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
  3. Impaired hepatic function
  4. Gastric by pass surgery
  5. Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
  6. Treatment with anti-obesity drugs
  7. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  8. Premenopausal 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 during the trial

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): NCT00996658


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Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00996658     History of Changes
Other Study ID Numbers: 1218.61
2009-013289-20 ( EudraCT Number: EudraCT )
First Posted: October 16, 2009    Key Record Dates
Results First Posted: March 26, 2013
Last Update Posted: March 26, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
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