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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00819091 |
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Date of registration:
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07/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug. |
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Date of first enrolment:
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December 2008 |
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Target sample size:
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245 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00819091 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Hungary
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India
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Japan
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Poland
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Russian Federation
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Ukraine
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control
[glycosylated hemoglobin (HbA1c 7% to 10%)] despite therapy with a sulfonylurea drug
Exclusion criteria:
Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with
rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3
months Impaired hepatic function Severe renal impairment Current treatment with systemic
steroids Change in thyroid hormone dosage Hereditary galactose intolerance
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Placebo
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Drug: BI 1356
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Primary Outcome(s)
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Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18
[Time Frame: Baseline, week 18]
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Secondary Outcome(s)
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Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6
[Time Frame: Baseline, week 6]
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Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18
[Time Frame: week 18]
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Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18
[Time Frame: Baseline, week 18]
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Change From Baseline in Fasting Plasma Glucose at Week 6
[Time Frame: Baseline, week 6]
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Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18
[Time Frame: Baseline, week 18]
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Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18
[Time Frame: week 18]
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Change From Baseline in Fasting Plasma Glucose at Week 12
[Time Frame: Baseline, week 12]
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Change From Baseline in Fasting Plasma Glucose at Week 18
[Time Frame: Baseline, week 18]
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Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12
[Time Frame: Baseline, week 12]
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Secondary ID(s)
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2008-003118-86
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1218.35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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