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

Tracking Information

Start Date  ICMJEAugust 2009
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Current 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 ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00954447 on ClinicalTrials.gov Archive Site
Current 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 ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEEfficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Official Title  ICMJEA 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 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Linagliptin
  • Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1235
Completion Date 
Estimated Primary Completion DateSeptember 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
Ages18 Years and older
Accepts Healthy Volunteers 
Contacts  ICMJE
Contact: Boehringer Ingelheim Study Coordinator1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
Location Countries  ICMJEUnited States,   Argentina,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Finland,   Germany,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan

Administrative Information

Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1218.36, EUDRACT 2008-008296-33
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals