Status:
COMPLETED
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-79 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 given for 24 weeks as add on therapy to metformin in com...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of diabetes mellitus prior to informed consent
- Patients treated with metformin and pioglitazone (therapy should be unchanged for 12 weeks)
- Glycosylated haemoglobin A1 \>= 7.5% and \<= 10%
- Age between 18 and less than 80
- \- Body Mass index less or equal to 45
- Exclusion criteria:
- Uncontrolled hyperglycaemia during run in period
- Myocardial infarction, stroke or transient ischaemic accident within 3 months prior to informed consent
- Impaired hepatic function
- Gastric by pass surgery
- Treatment with roziglitazone, GLP 1 analogues, DPP-4 inhibitors or insulin within 3 months prior to informed consent
- Treatment with anti-obesity drugs
- Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Premenopausal women 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 during the trial
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00996658
Start Date
October 1 2009
Last Update
March 26 2014
Active Locations (52)
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1
1218.61.01028 Boehringer Ingelheim Investigational Site
Escondido, California, United States
2
1218.61.01014 Boehringer Ingelheim Investigational Site
Greenbrae, California, United States
3
1218.61.01015 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
4
1218.61.01042 Boehringer Ingelheim Investigational Site
Paramount, California, United States