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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01084005 |
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Date of registration:
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09/03/2010 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes
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Scientific title:
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A Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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241 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01084005 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Canada
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Denmark
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Netherlands
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Sweden
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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 Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Type 2 diabetes mellitus
2. HbA1c >= 7.0%
3. Age >= 70 years
4. Signed and dated written informed consent
Exclusion criteria:
1. Myocardial infarction, stroke or TIA within 3 months prior to informed consent
2. Impaired hepatic function
3. Treatment with glitazones, GLP-1 analogues, DPP-4 inhibitors or rapid acting or
pre-mixed insulins
4. Treatment with anti-obesity drugs
Age minimum:
70 Years
Age maximum:
N/A
Gender:
Both
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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: linagliptin
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Drug: placebo
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Primary Outcome(s)
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HbA1c Change From Baseline to Week 24
[Time Frame: Baseline and week 24]
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Secondary Outcome(s)
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FPG Change From Baseline to Week 12
[Time Frame: Baseline and week 12]
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FPG Change From Baseline to Week 18
[Time Frame: Baseline and week 18]
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FPG Change From Baseline to Week 24
[Time Frame: Baseline and week 24]
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FPG Change From Baseline to Week 6
[Time Frame: Baseline and week 6]
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HbA1c Change From Baseline to Week 12
[Time Frame: Baseline and week 12]
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HbA1c Change From Baseline to Week 18
[Time Frame: Baseline and week 18]
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HbA1c Change From Baseline to Week 6
[Time Frame: Baseline and week 6]
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Number of Patients With Rescue Therapy
[Time Frame: week 24]
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Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5% at Week 24
[Time Frame: Baseline and week 24]
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Percentage of Patients With HbA1c <7.0% at Week 24
[Time Frame: Baseline and week 24]
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Secondary ID(s)
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1218.63
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2009-015255-25
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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