Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00798161
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 857
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1356 + metformin Bi 1356 + metformin BI 1356 low dose + metformin 500 mg, twice daily matching placebo matching placebo matching placebo BI 1356+ Metformin Bi 1356 + metformin BI 1356 low dose + metformin 1000 mg, twice daily Metformin metformin Metformin 500 mg, twice daily BI 1356 BI 1356 BI 1356 high dose, once daily metformin metformin Metformin 1000 mg, twice daily
- Primary Outcome Measures
Name Time Method HbA1c Change From Baseline at Week 24 Baseline and week 24 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
- Secondary Outcome Measures
Name Time Method HbA1c Change From Baseline at Week 6 Baseline and week 6 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 12 Baseline and week 12 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 18 Baseline and week 18 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
FPG Change From Baseline at Week 24 Baseline and week 24 This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 2 Baseline and week 2 This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 6 Baseline and week 6 This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 12 Baseline and week 12 This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 18 Baseline and week 18 This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Percentage of Patients With HbA1c <7.0% at Week 24 Baseline and Week 24 The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c<7.0 at Week 24 Baseline and Week 24 The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c <6.5% at Week 24 Baseline and Week 24 The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =\< 6.5%
Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24 Baseline and week 24 This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.
Percentage of Patients With HbA1c < 6.5% at Week 24 Baseline and Week 24 The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%
HbA1c Change From Baseline at Week 24 for Open-label Patients Baseline and week 24 HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.
FPG Change From Baseline at Week 24 for Open-label Patients Baseline and week 24 This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.
Use of Rescue Therapy 24 weeks The use of rescue therapy (SUs, thiazolidinediones \[TZDs\], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 24 Baseline and week 24 The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.
Trial Locations
- Locations (138)
1218.46.11005 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1218.46.11003 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1218.46.11002 Boehringer Ingelheim Investigational Site
🇨🇦Red Deer, Alberta, Canada
1218.46.11006 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada
1218.46.11008 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Manitoba, Canada
1218.46.11004 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1218.46.11007 Boehringer Ingelheim Investigational Site
🇨🇦Oakville, Ontario, Canada
1218.46.11009 Boehringer Ingelheim Investigational Site
🇨🇦Oshawa, Ontario, Canada
1218.46.11010 Boehringer Ingelheim Investigational Site
🇨🇦Toronto, Ontario, Canada
1218.46.38502 Boehringer Ingelheim Investigational Site
🇭🇷Karlovac, Croatia
Scroll for more (128 remaining)1218.46.11005 Boehringer Ingelheim Investigational Site🇨🇦Calgary, Alberta, Canada