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Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone

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: NCT00641043
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : June 7, 2011
Last Update Posted : February 17, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE February 29, 2008
First Posted Date  ICMJE March 21, 2008
Results First Submitted Date  ICMJE May 13, 2011
Results First Posted Date  ICMJE June 7, 2011
Last Update Posted Date February 17, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2011)
HbA1c Change From Baseline to 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
Change from baseline in HbA1c (HbA1c after 24 weeks of treatment). [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2011)
  • HbA1c Change From Baseline to 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.
  • HbA1c Change From Baseline to 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.
  • HbA1c Change From Baseline to 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.
  • FPG Change From Baseline to 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.
  • FPG Change From Baseline to 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.
  • FPG Change From Baseline to 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.
  • FPG Change From Baseline to 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-diabetes medication.
  • 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%. Only patients with baseline HbA1c >= 7%
  • 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%.
  • 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%
  • 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%
  • Percentage of Patients Who Have an 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%.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2008)
Secondary endpoints are: The change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. The occurrence of a treat to target response that is an HbA1c under treatment of < or = to 7%. [ 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 Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone
Official Title  ICMJE A Randomised, Double-blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control.
Brief Summary The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg 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 + pioglitazone (30 mg)
    placebo + overcapsulated 30 mg tablet, once daily
  • Drug: Linagliptin + pioglitazone (30 mg)
    5 mg tablet + overcapsulated 30 mg tablet, once daily
Study Arms  ICMJE
  • Experimental: BI 1356 (5 mg)
    BI 1356 5mg in initial combination therapy with pioglitazone 30 mg
    Intervention: Drug: Linagliptin + pioglitazone (30 mg)
  • Placebo Comparator: Placebo matching BI 1356 5 mg
    Placebo in initial combination therapy with pioglitazone 30 mg
    Intervention: Drug: placebo + pioglitazone (30 mg)
Publications * Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.

*   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: June 24, 2009)
389
Original Enrollment  ICMJE
 (submitted: March 20, 2008)
375
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Signed and dated written Informed Consent (IC) by date of Visit 1a in accordance with Good Clinical Practice (GCP) and local legislation
  2. Patients with a diagnosis of type 2 diabetes mellitus and treatment naive or previously treated with any oral hypoglycaemic agent; antidiabetic therapy has to be unchanged for ten weeks prior to informed consent.
  3. Glycosylated haemoglobin A1 (HbA1c) 7.5-11% at Visit 2 (Start of Run-in).
  4. Male and female patients aged > or = 18 and < or = to 80 years at Visit 1a (Screening).
  5. Body Mass Index (BMI) < or = 40 kg/m2 at Visit 1a (Screening)
  6. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria:

  1. Myocardial infarction, stroke or Transient Isquemic Atack (TIA) within 6 months prior to Inform Consent (IC)
  2. Impaired hepatic function, defined by serum levels of either Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) determined at Visit 1a.
  3. Known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients
  4. Treatment with Glucagon-like peptide-1 (GLP-1) analogue / agonist within 3 months prior to IC.
  5. Treatment with insulin within 3 months prior to IC
  6. Treatment with anti-obesity drugs 3 months prior to IC.
  7. Alcohol abuse within the 3 months prior to IC that would interfere with trial participation or drug abuse.
  8. Participation in another trial with an investigational drug within 2 months prior to IC.
  9. Fasting blood glucose > 240 mg/dl (=13.3 mmol/L) at screening (Visit 1).
  10. Pre-menopausal women (last menstruation < or =1 year prior to signing IC) 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. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
  11. Treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to IC
  12. Heart failure New York Heart Asociation (NYHA) class I-IV, or history of heart failure.
  13. Diabetic ketoacidosis within 6 months prior to IC.
  14. Hemodialyzed patients due to limited experience with Thiazolidinediones (TZDs)
  15. Any other clinical condition wich, in the opinion of the investigator, would not alow safe completion of the protocol and safe administration of BI1356 and pioglitazone.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 Austria,   Greece,   Hungary,   Japan,   Portugal,   Romania,   Spain
Removed Location Countries Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00641043
Other Study ID Numbers  ICMJE 1218.15
2007-002456-41 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2014

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