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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00996658
First received: October 15, 2009
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo
Drug: Linagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin


Secondary Outcome Measures:
  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks [ Time Frame: baseline, 6 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks [ Time Frame: baseline, 18 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

  • Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks [ Time Frame: baseline, 24 weeks ] [ Designated as safety issue: No ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24

  • Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks [ Time Frame: baseline, 6 weeks ] [ Designated as safety issue: No ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6

  • Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12

  • Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks [ Time Frame: baseline, 18 weeks ] [ Designated as safety issue: No ]
    Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18


Enrollment: 278
Study Start Date: October 2009
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996658

  Show 52 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00996658     History of Changes
Other Study ID Numbers: 1218.61, 2009-013289-20
Study First Received: October 15, 2009
Results First Received: February 13, 2013
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Philippines: Department of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014