| Trial ID: | L6951 |
| Source ID: | NCT01215097
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| Associated Drug: |
Linagliptin
|
| Title: |
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01215097/results
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| Conditions: |
Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: Linagliptin|DRUG: placebo
|
| Outcome Measures: |
Primary: HbA1c Change From Baseline at Week 24, Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and at week 24 | Secondary: HbA1c Change From Baseline at Week 6, Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and at week 6|HbA1c Change From Baseline at Week 12, Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and at week 12|HbA1c Change From Baseline at Week 18, Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and at week 18|HbA1c Change From Baseline at Week 24(Chinese Only), Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication., Baseline and at 24 weeks|FPG Change From Baseline at Week 24, Means are treatment adjusted for baseline fasting plasma glucose (FPG) and previous anti-diabetic medication., Baseline and at week 24|FPG Change From Baseline at Week 6, Means are treatment adjusted for baseline FPG and previous anti-diabetic medication., Baseline and at week 6|FPG Change From Baseline at Week 12, Means are treatment adjusted for baseline FPG and previous anti-diabetic medication., Baseline and at week 12|FPG Change From Baseline at Week 18, Means are treatment adjusted for baseline FPG and previous anti-diabetic medication., Baseline and at week 18|Number of Patients With HbA1c < 7.0%, Number of patients with HbA1c \< 7.0% at week 24, baseline and at week 24|Number of Patients With HbA1c < 7.0% at Week 24 With Baseline HbA1c >= 7.0%., Number of patients with HbA1c \< 7.0% at week 24 with baseline HbA1c \>= 7.0%., baseline and at week 24|Number of Patients With HbA1c < 6.5%, Number of patients with HbA1c \< 6.5% at week 24, baseline and at week 24|Number of Patients With HbA1c < 6.5% at Week 24 With Baseline HbA1c >= 6.5%., Number of patients with HbA1c \< 6.5% at week 24 with baseline HbA1c \>= 6.5%., baseline and at week 24|Number With HbA1c at Least Lowering 0.5%, Number with HbA1c at least 0.5% lowering from baseline at week 24, baseline and at week 24
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| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
306
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
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| Start Date: |
2010-10
|
| Completion Date: |
2012-04
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| Results First Posted: |
2013-06-03
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| Last Update Posted: |
2016-08-25
|
| Locations: |
1218.65.86007 Boehringer Ingelheim Investigational Site, Beijing, China|1218.65.86011 Boehringer Ingelheim Investigational Site, Chongqing, China|1218.65.86008 Boehringer Ingelheim Investigational Site, Dalian, China|1218.65.86010 Boehringer Ingelheim Investigational Site, Fuzhou, China|1218.65.86014 Boehringer Ingelheim Investigational Site, Hangzhou, China|1218.65.86005 Boehringer Ingelheim Investigational Site, Hefei, China|1218.65.86006 Boehringer Ingelheim Investigational Site, Hefei, China|1218.65.86012 Boehringer Ingelheim Investigational Site, Nanjing, China|1218.65.86001 Boehringer Ingelheim Investigational Site, Shanghai, China|1218.65.86002 Boehringer Ingelheim Investigational Site, Shanghai, China|1218.65.86003 Boehringer Ingelheim Investigational Site, Shanghai, China|1218.65.86004 Boehringer Ingelheim Investigational Site, Suzhou, China|1218.65.86015 Boehringer Ingelheim Investigational Site, Wenzhou, China|1218.65.86009 Boehringer Ingelheim Investigational Site, Wuhan, China|1218.65.86013 Boehringer Ingelheim Investigational Site, Yangzhou, China|1218.65.60002 Boehringer Ingelheim Investigational Site, Johor Bahru,, Malaysia|1218.65.60001 Boehringer Ingelheim Investigational Site, Kelantan, Malaysia|1218.65.63001 Boehringer Ingelheim Investigational Site, Marikina, Philippines|1218.65.63002 Boehringer Ingelheim Investigational Site, San Juan, Philippines
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| URL: |
https://clinicaltrials.gov/show/NCT01215097
|
