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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

Tracking Information
First Submitted Date  ICMJE October 15, 2009
First Posted Date  ICMJE October 16, 2009
Results First Submitted Date  ICMJE February 13, 2013
Results First Posted Date  ICMJE March 26, 2013
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Change from baseline in glycosylated haemoglobin A1 after 24 weeks of treatment. [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
occurrence of HbA1c under treatment of <7.0% and of <6.5% after 24 weeks Hba1c lowering by at least 0.5% after 24 weeks of HbA1c reduction from baseline by visit over time change in fasting plasma glucose from baseline after 24 weeks [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo
    Placebo matching linagliptin tablets once daily
  • Drug: Linagliptin
    Linagliptin tablets once daily
Study Arms  ICMJE
  • Experimental: Linagliptin
    Linagliptin tablets once daily
    Intervention: Drug: Linagliptin
  • Placebo Comparator: Placebo
    Placebo tablets once daily
    Intervention: Drug: Placebo
Publications * Bajaj M, Gilman R, Patel S, Kempthorne-Rawson J, Lewis-D'Agostino D, Woerle HJ. Linagliptin improved glycaemic control without weight gain or hypoglycaemia in patients with type 2 diabetes inadequately controlled by a combination of metformin and pioglitazone: a 24-week randomized, double-blind study. Diabet Med. 2014 Dec;31(12):1505-14. doi: 10.1111/dme.12495. Epub 2014 Jul 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2012)
278
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
290
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   India,   Philippines,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00996658
Other Study ID Numbers  ICMJE 1218.61
2009-013289-20 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Boehringer Ingelheim
Original Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Current Study Sponsor  ICMJE Boehringer Ingelheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP