The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic Patients
NCT ID: NCT00716092
Last Updated: 2014-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin.
Placebo (linagliptin)
once daily for 28 days
Placebo (sitagliptin)
once daily for 28 days
Linagliptin
Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin.
Placebo (sitagliptin)
once daily for 28 days
Linagliptin
5mg once daily for 28 days
Sitagliptin
Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.
Placebo (linagliptin)
once daily for 28 days
Sitagliptin
100 mg once daily for 28 days
Interventions
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Placebo (linagliptin)
once daily for 28 days
Placebo (linagliptin)
once daily for 28 days
Sitagliptin
100 mg once daily for 28 days
Placebo (sitagliptin)
once daily for 28 days
Placebo (sitagliptin)
once daily for 28 days
Linagliptin
5mg once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Glycosylated haemoglobin A1 (HbA1c) 6.5 to 10.0% at Start of Run-in
Exclusion Criteria
* Impaired hepatic function
* Renal insufficiency with a creatinine clearance \< 50 mL/min
* Treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (GLP-1) analogues, insulin, dipeptidyl peptidase 4 (DPP-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.
18 Years
80 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1218.37.49003 Boehringer Ingelheim Investigational Site
Berlin, , Germany
1218.37.49002 Boehringer Ingelheim Investigational Site
Mainz, , Germany
1218.37.49001 Boehringer Ingelheim Investigational Site
Neuss, , Germany
Countries
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Other Identifiers
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2007-007865-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1218.37
Identifier Type: -
Identifier Source: org_study_id
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