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Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

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: NCT00954447
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : September 27, 2012
Last Update Posted : December 30, 2013
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 6, 2009
First Posted Date  ICMJE August 7, 2009
Results First Submitted Date  ICMJE August 28, 2012
Results First Posted Date  ICMJE September 27, 2012
Last Update Posted Date December 30, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
Change From Baseline in HbA1c After 24 Weeks [ Time Frame: Baseline and 24 weeks ]
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment. [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Number of Patients With HbA1c < 7.0 Percent [ Time Frame: 24 and 52 weeks ]
  • Number of Patients Lowering HbA1c by at Least 0.5 Percent [ Time Frame: 24 and 52 weeks ]
  • Change From Baseline in HbA1c by Visit at Week 6 [ Time Frame: Baseline and 6 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
  • Change From Baseline in HbA1c by Visit at Week 12 [ Time Frame: Baseline and 12 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
  • Change From Baseline in HbA1c by Visit at Week 18 [ Time Frame: Baseline and 18 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
  • Change From Baseline in HbA1c by Visit at Week 32 [ Time Frame: Baseline and 32 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
  • Change From Baseline in HbA1c by Visit at Week 40 [ Time Frame: Baseline and 40 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
  • Change From Baseline in HbA1c by Visit at Week 52 [ Time Frame: Baseline and 52 weeks ]
    Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
  • Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks ]
    Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
  • Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]
  • Change From Baseline in FPG [ Time Frame: Baseline, 6, 12, 18, 24, 32 and 40 weeks ]
  • Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment [ Time Frame: Baseline and 52 weeks ]
    Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
  • Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment [ Time Frame: Baseline, 24 and 52 weeks ]
    Mean Daily Glucose was calculated using the 8-point blood glucose profile
  • Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment [ Time Frame: Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
HbA1c over time, treatment to target response FPG change from baseline, over time, treat to target response Insulin dose change Frequency of AE, hypoglycemic events, rescue therapy Change from baseline in vital signs, weight, waist, lipid parameters [ Time Frame: 52-130 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: August 28, 2012)
Number of Patients With HbA1c < 6.5 Percent [ Time Frame: 24 and 52 weeks ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
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 for at Least 52 Weeks in Type 2 Diabetic Patients in Combination With Basal Insulin Therapy
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 during long term treatment (52 weeks and longer) in combination with basal insulin 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, identical to Linagliptin tablet
  • Drug: Linagliptin
    intended final marketed dose
Study Arms  ICMJE
  • Experimental: Linagliptin
    patient receives a tablet with intended final marketed dose
    Intervention: Drug: Linagliptin
  • Placebo Comparator: Placebo
    patient receives a tablet identical to those containing Linagliptin
    Intervention: Drug: 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: September 22, 2011)
1263
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2009)
1200
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Diabetes type 2, detectable C-peptide, HbA1c 7-10%
  2. Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age > 18 years, BMI <= 45 kg/m2

Exclusion criteria:

  1. Uncontrolled hyperglycemia during Run-in
  2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
  3. Liver impairment; gastric surgery; medical history of cancer in last 5 years
  4. Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
  5. Unsufficient birth control, pregnancy and nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Argentina,   Belgium,   Brazil,   Canada,   Czech Republic,   Finland,   Germany,   Greece,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United States
Removed Location Countries Chile,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT00954447
Other Study ID Numbers  ICMJE 1218.36
2008-008296-33 ( 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 Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date October 2012

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