Status:
COMPLETED
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 co...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diabetes type 2, detectable C-peptide, HbA1c 7-10%
- Pretreatment with basal insulin +/- Metformin or/and +/- Pioglitazone 3 Age \> 18 years, BMI \<= 45 kg/m2
- Exclusion criteria:
- Uncontrolled hyperglycemia during Run-in
- Myocardial infarction, stroke or TIA within 3 months prior to informed consent
- Liver impairment; gastric surgery; medical history of cancer in last 5 years
- Other antidiabetic drugs, antiobesity drugs, systemic steroids, other investigational drug before randomisation
- Unsufficient birth control, pregnancy and nursing
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1263 Patients enrolled
Trial Details
Trial ID
NCT00954447
Start Date
August 1 2009
Last Update
December 30 2013
Active Locations (169)
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1
1218.36.01043 Boehringer Ingelheim Investigational Site
Escondido, California, United States
2
1218.36.01051 Boehringer Ingelheim Investigational Site
Escondido, California, United States
3
1218.36.01065 Boehringer Ingelheim Investigational Site
Fresno, California, United States
4
1218.36.01021 Boehringer Ingelheim Investigational Site
Greenbrae, California, United States