Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01512979
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description linagliptin linagliptin patients receive linagliptin tablet once daily linagliptin plus metformin metformin placebo patients receive linagliptin tablet once daily and metformin tablets twice daily linagliptin metformin placebo patients receive linagliptin tablet once daily linagliptin plus metformin linagliptin patients receive linagliptin tablet once daily and metformin tablets twice daily linagliptin plus metformin metformin patients receive linagliptin tablet once daily and metformin tablets twice daily
- Primary Outcome Measures
Name Time Method Change From Baseline in HbA1c After 24 Weeks Baseline and 24 weeks HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment Baseline and 24 weeks The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.
Change From Baseline in HbA1c by Visit Over Time Baseline, 6, 12, 18 and 24 weeks HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment) Baseline and 24 weeks The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment) Baseline and 24 weeks The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment Baseline and 24 weeks The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
Change From Baseline in FPG by Visit Over Time Baseline, 6, 12, 18 and 24 weeks The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.
Trial Locations
- Locations (82)
1218.83.11022 Boehringer Ingelheim Investigational Site
🇺🇸Fort Lauderdale, Florida, United States
1218.83.11013 Boehringer Ingelheim Investigational Site
🇺🇸Jacksonville, North Carolina, United States
1218.83.11017 Boehringer Ingelheim Investigational Site
🇺🇸Chattanooga, Tennessee, United States
1218.83.11003 Boehringer Ingelheim Investigational Site
🇺🇸Franklin, Ohio, United States
1218.83.11030 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
1218.83.11018 Boehringer Ingelheim Investigational Site
🇺🇸Columbia, South Carolina, United States
1218.83.11031 Boehringer Ingelheim Investigational Site
🇺🇸San Diego, California, United States
1218.83.11026 Boehringer Ingelheim Investigational Site
🇺🇸Owensboro, Kentucky, United States
1218.83.11002 Boehringer Ingelheim Investigational Site
🇺🇸Phoenix, Arizona, United States
1218.83.11029 Boehringer Ingelheim Investigational Site
🇺🇸Oakwood, Georgia, United States
1218.83.11036 Boehringer Ingelheim Investigational Site
🇺🇸Little Rock, Arkansas, United States
1218.83.11021 Boehringer Ingelheim Investigational Site
🇺🇸Tomball, Texas, United States
1218.83.97007 Boehringer Ingelheim Investigational Site
🇮🇱Holon, Israel
1218.83.60001 Boehringer Ingelheim Investigational Site
🇲🇾Kelantan, Malaysia
1218.83.52005 Boehringer Ingelheim Investigational Site
🇲🇽Merida, Mexico
1218.83.52003 Boehringer Ingelheim Investigational Site
🇲🇽Tampico, Mexico
1218.83.07001 Boehringer Ingelheim Investigational Site
🇷🇺Kazan, Russian Federation
1218.83.11001 Boehringer Ingelheim Investigational Site
🇺🇸Huntington Beach, California, United States
1218.83.11011 Boehringer Ingelheim Investigational Site
🇺🇸Chino, California, United States
1218.83.11014 Boehringer Ingelheim Investigational Site
🇺🇸Roseville, California, United States
1218.83.11019 Boehringer Ingelheim Investigational Site
🇺🇸Huntington Park, California, United States
1218.83.11015 Boehringer Ingelheim Investigational Site
🇺🇸Lomita, California, United States
1218.83.11023 Boehringer Ingelheim Investigational Site
🇺🇸Norwalk, California, United States
1218.83.11033 Boehringer Ingelheim Investigational Site
🇺🇸Sanford, Florida, United States
1218.83.11005 Boehringer Ingelheim Investigational Site
🇺🇸Edison, New Jersey, United States
1218.83.11027 Boehringer Ingelheim Investigational Site
🇺🇸Freemont, Nebraska, United States
1218.83.11009 Boehringer Ingelheim Investigational Site
🇺🇸Shelby, North Carolina, United States
1218.83.11028 Boehringer Ingelheim Investigational Site
🇺🇸Salisbury, North Carolina, United States
1218.83.11024 Boehringer Ingelheim Investigational Site
🇺🇸Gallipolis, Ohio, United States
1218.83.11004 Boehringer Ingelheim Investigational Site
🇺🇸Bristol, Tennessee, United States
1218.83.11034 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1218.83.11032 Boehringer Ingelheim Investigational Site
🇺🇸Grand Prairie, Texas, United States
1218.83.12011 Boehringer Ingelheim Investigational Site
🇨🇦Calgary, Alberta, Canada
1218.83.12007 Boehringer Ingelheim Investigational Site
🇨🇦Edmonton, Alberta, Canada
1218.83.12002 Boehringer Ingelheim Investigational Site
🇨🇦Paradise, Newfoundland and Labrador, Canada
1218.83.12001 Boehringer Ingelheim Investigational Site
🇨🇦Red Deer, Alberta, Canada
1218.83.12009 Boehringer Ingelheim Investigational Site
🇨🇦St. John's, Newfoundland and Labrador, Canada
1218.83.12005 Boehringer Ingelheim Investigational Site
🇨🇦Kitchener, Ontario, Canada
1218.83.12006 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1218.83.12010 Boehringer Ingelheim Investigational Site
🇨🇦Sudbury, Ontario, Canada
1218.83.12012 Boehringer Ingelheim Investigational Site
🇨🇦Winnipeg, Ontario, Canada
1218.83.63007 Boehringer Ingelheim Investigational Site
🇵🇭Cebu City, Philippines
1218.83.63004 Boehringer Ingelheim Investigational Site
🇵🇭Quezon, Philippines
1218.83.97004 Boehringer Ingelheim Investigational Site
🇮🇱Haifa, Israel
1218.83.12003 Boehringer Ingelheim Investigational Site
🇨🇦Smiths Falls, Ontario, Canada
1218.83.91005 Boehringer Ingelheim Investigational Site
🇮🇳Chennai, India
1218.83.91001 Boehringer Ingelheim Investigational Site
🇮🇳Mumbai, India
1218.83.97005 Boehringer Ingelheim Investigational Site
🇮🇱Haifa, Israel
1218.83.60002 Boehringer Ingelheim Investigational Site
🇲🇾Perak, Malaysia
1218.83.11025 Boehringer Ingelheim Investigational Site
🇺🇸Orlando, Florida, United States
1218.83.52001 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1218.83.63001 Boehringer Ingelheim Investigational Site
🇵🇭Cebu, Philippines
1218.83.11037 Boehringer Ingelheim Investigational Site
🇵🇷San Juan, Puerto Rico
1218.83.38005 Boehringer Ingelheim Investigational Site
🇺🇦Vinnytsya, Ukraine
1218.83.60003 Boehringer Ingelheim Investigational Site
🇲🇾Selangor, Malaysia, Malaysia
1218.83.63008 Boehringer Ingelheim Investigational Site
🇵🇭Iloilo City, Philippines
1218.83.63002 Boehringer Ingelheim Investigational Site
🇵🇭Marikina City, Philippines
1218.83.07006 Boehringer Ingelheim Investigational Site
🇷🇺Smolensk, Russian Federation
1218.83.94004 Boehringer Ingelheim Investigational Site
🇱🇰Dehiwela, Sri Lanka
1218.83.38003 Boehringer Ingelheim Investigational Site
🇺🇦Vinnytsya, Ukraine
1218.83.91003 Boehringer Ingelheim Investigational Site
🇮🇳Bangalore, India
1218.83.52004 Boehringer Ingelheim Investigational Site
🇲🇽Cuautla, Mexico
1218.83.52002 Boehringer Ingelheim Investigational Site
🇲🇽Guadalajara, Mexico
1218.83.63003 Boehringer Ingelheim Investigational Site
🇵🇭Iloilo, Philippines
1218.83.63006 Boehringer Ingelheim Investigational Site
🇵🇭Marikina City, Philippines
1218.83.07007 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.83.07005 Boehringer Ingelheim Investigational Site
🇷🇺Yaroslavl, Russian Federation
1218.83.94003 Boehringer Ingelheim Investigational Site
🇱🇰Kandy, Sri Lanka
1218.83.66002 Boehringer Ingelheim Investigational Site
🇹🇭Bangkok, Thailand
1218.83.66003 Boehringer Ingelheim Investigational Site
🇹🇭Bangkok, Thailand
1218.83.66001 Boehringer Ingelheim Investigational Site
🇹🇭Muang, Khonkaen, Thailand
1218.83.38007 Boehringer Ingelheim Investigational Site
🇺🇦Dnepropetrovsk, Ukraine
1218.83.11008 Boehringer Ingelheim Investigational Site
🇺🇸Elkton, Maryland, United States
1218.83.07002 Boehringer Ingelheim Investigational Site
🇷🇺Petrozavodsk, Russian Federation
1218.83.07003 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1218.83.38004 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1218.83.07004 Boehringer Ingelheim Investigational Site
🇷🇺Samara, Russian Federation
1218.83.94002 Boehringer Ingelheim Investigational Site
🇱🇰Galle, Sri Lanka, Sri Lanka
1218.83.94001 Boehringer Ingelheim Investigational Site
🇱🇰Ragama, Sri Lanka
1218.83.38001 Boehringer Ingelheim Investigational Site
🇺🇦Ivano-Frankivsk, Ukraine
1218.83.38006 Boehringer Ingelheim Investigational Site
🇺🇦Kharkiv, Ukraine
1218.83.38008 Boehringer Ingelheim Investigational Site
🇺🇦Vinnitsa, Ukraine