Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
- Registration Number
- NCT00996658
- 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 given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 278
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo tablets once daily Linagliptin Linagliptin Linagliptin tablets once daily
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks baseline, 24 weeks Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
- Secondary Outcome Measures
Name Time Method Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks baseline, 6 weeks Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks baseline, 12 weeks Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks baseline, 18 weeks Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks 24 weeks Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks 24 weeks Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks 24 weeks Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks baseline, 24 weeks Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 24
Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks baseline, 6 weeks Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 6
Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks baseline, 12 weeks Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 12
Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks baseline, 18 weeks Adjusted mean change in fasting plasma glucose (FPG) from baseline at week 18
Related Research Topics
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Trial Locations
- Locations (52)
1218.61.63004 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Cebu City, Philippines
1218.61.63002 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Davao City, Philippines
1218.61.01042 Boehringer Ingelheim Investigational Site
🇺🇸Paramount, California, United States
1218.61.01046 Boehringer Ingelheim Investigational Site
🇺🇸Poway, California, United States
1218.61.01014 Boehringer Ingelheim Investigational Site
🇺🇸Greenbrae, California, United States
1218.61.01009 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1218.61.01028 Boehringer Ingelheim Investigational Site
🇺🇸Escondido, California, United States
1218.61.01040 Boehringer Ingelheim Investigational Site
🇺🇸Meridian, Idaho, United States
1218.61.01001 Boehringer Ingelheim Investigational Site
🇺🇸Auburn, Maine, United States
1218.61.3301A Boehringer Ingelheim Investigational Site
🇫🇷Besancon, France
1218.61.01017 Boehringer Ingelheim Investigational Site
🇺🇸Simpsonville, South Carolina, United States
1218.61.01005 Boehringer Ingelheim Investigational Site
🇺🇸Dallas, Texas, United States
1218.61.01008 Boehringer Ingelheim Investigational Site
🇺🇸Roswell, Georgia, United States
1218.61.01015 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
1218.61.01044 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1218.61.01049 Boehringer Ingelheim Investigational Site
🇺🇸Lawrenceville, Georgia, United States
1218.61.01016 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1218.61.01043 Boehringer Ingelheim Investigational Site
🇺🇸Olive Branch, Mississippi, United States
1218.61.01048 Boehringer Ingelheim Investigational Site
🇺🇸Lafayette, Indiana, United States
1218.61.01018 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1218.61.01052 Boehringer Ingelheim Investigational Site
🇺🇸Las Vegas, Nevada, United States
1218.61.01004 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, North Carolina, United States
1218.61.01007 Boehringer Ingelheim Investigational Site
🇺🇸Greensboro, North Carolina, United States
1218.61.01030 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
1218.61.01031 Boehringer Ingelheim Investigational Site
🇺🇸East Providence, Rhode Island, United States
1218.61.01027 Boehringer Ingelheim Investigational Site
🇺🇸Perrysburg, Ohio, United States
1218.61.01023 Boehringer Ingelheim Investigational Site
🇺🇸Wilmington, North Carolina, United States
1218.61.3307A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1218.61.01053 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1218.61.3306A Boehringer Ingelheim Investigational Site
🇫🇷Beziers, France
1218.61.01003 Boehringer Ingelheim Investigational Site
🇺🇸Sugar Land, Texas, United States
1218.61.01024 Boehringer Ingelheim Investigational Site
🇺🇸Bennington, Vermont, United States
1218.61.3310A Boehringer Ingelheim Investigational Site
🇫🇷Cournonterral, France
1218.61.3311A Boehringer Ingelheim Investigational Site
🇫🇷Beziers, France
1218.61.3312A Boehringer Ingelheim Investigational Site
🇫🇷Laval, France
1218.61.3309A Boehringer Ingelheim Investigational Site
🇫🇷Bourg des cptes, France
1218.61.3313A Boehringer Ingelheim Investigational Site
🇫🇷Louvigne De bais, France
1218.61.3305A Boehringer Ingelheim Investigational Site
🇫🇷Paris, France
1218.61.91003 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.61.91002 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.61.91004 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.61.91008 Boehringer Ingelheim Investigational Site
🇮🇳Hyderabad, India
1218.61.91009 Boehringer Ingelheim Investigational Site
🇮🇳Jaipur, India
1218.61.91010 Boehringer Ingelheim Investigational Site
🇮🇳Karnataka, India
1218.61.91001 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
1218.61.91006 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
1218.61.91005 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1218.61.91007 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1218.61.91011 Boehringer Ingelheim Investigational Site
🇮🇳Maharashtra, India
1218.61.63003 Boehringer Ingelheim Investigational Site
🇵ðŸ‡Cebu City, Philippines
1218.61.01020 Boehringer Ingelheim Investigational Site
🇺🇸Spokane, Washington, United States
1218.61.01006 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States