Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
- Registration Number
- NCT00954447
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1263
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linagliptin Linagliptin patient receives a tablet with intended final marketed dose Placebo Placebo patient receives a tablet identical to those containing Linagliptin
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c After 24 Weeks Baseline and 24 weeks HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
- Secondary Outcome Measures
Name Time Method Number of Patients With HbA1c < 7.0 Percent 24 and 52 weeks Number of Patients Lowering HbA1c by at Least 0.5 Percent 24 and 52 weeks Change From Baseline in HbA1c by Visit at Week 6 Baseline and 6 weeks Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 12 Baseline and 12 weeks Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 18 Baseline and 18 weeks Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 32 Baseline and 32 weeks Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 40 Baseline and 40 weeks Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 52 Baseline and 52 weeks Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment Baseline and 24 weeks Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment Baseline and 52 weeks Change From Baseline in FPG Baseline, 6, 12, 18, 24, 32 and 40 weeks Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment Baseline and 52 weeks Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment Baseline, 24 and 52 weeks Mean Daily Glucose was calculated using the 8-point blood glucose profile
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner
Trial Locations
- Locations (169)
1218.36.01043 Boehringer Ingelheim Investigational Site
🇺🇸Escondido, California, United States
1218.36.01051 Boehringer Ingelheim Investigational Site
🇺🇸Escondido, California, United States
1218.36.01065 Boehringer Ingelheim Investigational Site
🇺🇸Fresno, California, United States
1218.36.01021 Boehringer Ingelheim Investigational Site
🇺🇸Greenbrae, California, United States
1218.36.01013 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1218.36.01048 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1218.36.01058 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1218.36.01008 Boehringer Ingelheim Investigational Site
🇺🇸Santa Ana, California, United States
1218.36.01056 Boehringer Ingelheim Investigational Site
🇺🇸Waterbury, Connecticut, United States
1218.36.01054 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
Scroll for more (159 remaining)1218.36.01043 Boehringer Ingelheim Investigational Site🇺🇸Escondido, California, United States