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Japanese P III vs Voglibose and Placebo

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ClinicalTrials.gov Identifier: NCT00654381
Recruitment Status : Completed
First Posted : April 8, 2008
Results First Posted : August 2, 2011
Last Update Posted : January 27, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE April 3, 2008
First Posted Date  ICMJE April 8, 2008
Results First Submitted Date  ICMJE May 18, 2011
Results First Posted Date  ICMJE August 2, 2011
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
  • Change From Baseline in HbA1c at Week 12 [ Time Frame: 12 weeks ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
  • Change From Baseline in HbA1c at Week 26 [ Time Frame: 26 weeks ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
  • Examination of Long-term Safety of Linagliptin (52-week Treatment) [ Time Frame: 52 weeks ]
    The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Change in HbA1c from baseline is determined to compare the efficacy of BI 1356 administered for 12 weeks to placebo and for 26 weeks to voglibose. [ Time Frame: 12 weeks (vs placebo), 26 weeks (vs voglibose), and ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
  • Relative Efficacy Response of HbA1c at Week 12 [ Time Frame: 12 weeks ]
    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
  • Relative Efficacy Response of HbA1c at Week 26 [ Time Frame: 26 weeks ]
    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
  • Relative Efficacy Response of HbA1c at Week 52 [ Time Frame: 52 weeks ]
    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: 12 weeks ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: 26 weeks ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: 52 weeks ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Relative efficacy response of HbA1c, etc. [ Time Frame: 12 weeks and 26 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Japanese P III vs Voglibose and Placebo
Official Title  ICMJE A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Brief Summary The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
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: BI 1356
    5 mg/daily
  • Drug: BI 1356
    10 mg/daily
  • Drug: voglibose placebo
    three times daily
  • Drug: BI 1356 placebo
    once daily
  • Drug: voglibose
    0.6 mg/daily
Study Arms  ICMJE
  • Active Comparator: voglibose 0.2 mg three times a day (TID)
    patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
    Intervention: Drug: voglibose
  • Experimental: BI 1356 low dose
    patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
    Intervention: Drug: BI 1356
  • Experimental: BI 1356 high dose
    patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
    Intervention: Drug: BI 1356
  • Placebo Comparator: placebo
    patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
    Interventions:
    • Drug: voglibose placebo
    • Drug: BI 1356 placebo
Publications *

*   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: March 1, 2010)
561
Original Enrollment  ICMJE
 (submitted: April 3, 2008)
441
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
  2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
  3. Age: >= 20 and <= 80
  4. Body Mass Index (BMI) <= 40 kg/m2

Exclusion criteria:

  1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
  2. Impaired hepatic function
  3. History of severe allergy/hypersensitivity
  4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
  5. Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00654381
Other Study ID Numbers  ICMJE 1218.23
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 December 2013

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