Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: linagliptin 5mgDrug: linagliptin2.5mg/metformin500mgDrug: linagliptin2.5mg/metformin1000mgDrug: Metformin 1000mgDrug: Metformin 500mg
- Registration Number
- NCT01708902
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 876
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description linagliptin2.5mg / metformin1000mg BID linagliptin 5mg patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID linagliptin2.5mg / metformin1000mg BID Metformin 1000mg patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID metformin 500mg BID linagliptin2.5mg/metformin500mg patient to receive a tablet containing metformin 500mg BID linagliptin2.5mg / metformin500mg BID Metformin 500mg patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID linagliptin 5 mg QD linagliptin2.5mg/metformin1000mg patient to receive a tablet containing linagliptin 5mg once daily linagliptin 5 mg QD linagliptin2.5mg/metformin500mg patient to receive a tablet containing linagliptin 5mg once daily linagliptin2.5mg / metformin500mg BID linagliptin 5mg patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID metformin 1000mg BID linagliptin2.5mg/metformin1000mg patient to receive a tablet containing metformin 1000mg BID
- Primary Outcome Measures
Name Time Method The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC) Baseline and week 24 The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \[OC\]) were considered.
The mean was adjusted by treatment, baseline HbA1c, week and treatment\*week.
The sensitivity analysis was added as the primary analysis failed with borderline results.The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group Baseline and week 24 The change from baseline in HbA1c after 24 weeks of treatment in main group.
The mean was adjusted by baseline HbA1c and treatment group.The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG Baseline and week 12 The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)
The mean was adjusted by baseline HbA1c and treatment group.
- Secondary Outcome Measures
Name Time Method The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG Week 12 (after first drug administration) The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 12 weeks of treatment in APG.
The Occurrence of Relative Efficacy Response in Main Group From baseline until week 24 The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group
The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG Baseline and week 12 The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group Week 24 (after first drug administration) The occurrence of treat to target efficacy response in terms of HbA1c \< 7.0 % after 24 weeks of treatment in main group.
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group Week 24 (after first drug administration) The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 24 weeks of treatment in main group.
The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG From baseline until week 12 The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.
The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG Week 12 (after first drug administration) The occurrence of treat to target efficacy response in terms of HbA1c \< 6.5% after 12 weeks of treatment in APG.
The Occurrence of Relative Efficacy Response in APG From baseline until week 12 The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG
The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group Baseline and week 24 The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.
Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group From baseline until week 24 The frequency of patients with use of rescue therapy during 24 week treatment period in main group.
For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group.
Trial Locations
- Locations (56)
1288.18.86010 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
1288.18.86039 Boehringer Ingelheim Investigational Site
🇨🇳Nanchang, China
1288.18.86024 Boehringer Ingelheim Investigational Site
🇨🇳Xi'An, China
1288.18.63002 Boehringer Ingelheim Investigational Site
🇵🇭Makati City, Philippines
1288.18.63005 Boehringer Ingelheim Investigational Site
🇵🇭Tagum City, Philippines
1288.18.86003 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1288.18.63007 Boehringer Ingelheim Investigational Site
🇵🇭Cebu, Philippines
1288.18.84002 Boehringer Ingelheim Investigational Site
🇻🇳Ho Chi Minh City, Vietnam
1288.18.86001 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1288.18.86002 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1288.18.86019 Boehringer Ingelheim Investigational Site
🇨🇳Changchun, China
1288.18.86004 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1288.18.86046 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
1288.18.86020 Boehringer Ingelheim Investigational Site
🇨🇳Changchun, China
1288.18.86028 Boehringer Ingelheim Investigational Site
🇨🇳Changsha, China
1288.18.86029 Boehringer Ingelheim Investigational Site
🇨🇳Changsha, China
1288.18.86050 Boehringer Ingelheim Investigational Site
🇨🇳Changsha, China
1288.18.86045 Boehringer Ingelheim Investigational Site
🇨🇳Chengdu, China
1288.18.86042 Boehringer Ingelheim Investigational Site
🇨🇳Chongqing, China
1288.18.86023 Boehringer Ingelheim Investigational Site
🇨🇳Dalian, China
1288.18.86009 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
1288.18.86012 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
1288.18.86047 Boehringer Ingelheim Investigational Site
🇨🇳Haerbin, China
1288.18.86032 Boehringer Ingelheim Investigational Site
🇨🇳Hefei, China
1288.18.86016 Boehringer Ingelheim Investigational Site
🇨🇳Hengshui, China
1288.18.86017 Boehringer Ingelheim Investigational Site
🇨🇳Jinan, China
1288.18.86026 Boehringer Ingelheim Investigational Site
🇨🇳Lanzhou, China
1288.18.86034 Boehringer Ingelheim Investigational Site
🇨🇳Nan Ning, China
1288.18.86006 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1288.18.86035 Boehringer Ingelheim Investigational Site
🇨🇳Nanjing, China
1288.18.86007 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1288.18.86008 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
1288.18.86013 Boehringer Ingelheim Investigational Site
🇨🇳Shantou, China
1288.18.86022 Boehringer Ingelheim Investigational Site
🇨🇳Shenyang, China
1288.18.86014 Boehringer Ingelheim Investigational Site
🇨🇳Shijiazhuang, China
1288.18.86015 Boehringer Ingelheim Investigational Site
🇨🇳Shijiazhuang, China
1288.18.86038 Boehringer Ingelheim Investigational Site
🇨🇳Suzhou, China
1288.18.86049 Boehringer Ingelheim Investigational Site
🇨🇳Wuhan, China
1288.18.86033 Boehringer Ingelheim Investigational Site
🇨🇳Wuhu, China
1288.18.86025 Boehringer Ingelheim Investigational Site
🇨🇳Xi'An, China
1288.18.86030 Boehringer Ingelheim Investigational Site
🇨🇳Yueyang, China
1288.18.60004 Boehringer Ingelheim Investigational Site
🇲🇾Kelantan, Malaysia
1288.18.60003 Boehringer Ingelheim Investigational Site
🇲🇾Selangor, Malaysia
1288.18.63003 Boehringer Ingelheim Investigational Site
🇵🇭Cebu City, Philippines
1288.18.84001 Boehringer Ingelheim Investigational Site
🇻🇳Ho Chi Minh City, Vietnam
1288.18.60007 Boehringer Ingelheim Investigational Site
🇲🇾Negeri Sembilan, Malaysia
1288.18.60006 Boehringer Ingelheim Investigational Site
🇲🇾Perak, Malaysia
1288.18.60001 Boehringer Ingelheim Investigational Site
🇲🇾Perak, Malaysia
1288.18.60002 Boehringer Ingelheim Investigational Site
🇲🇾Melaka, Malaysia
1288.18.60008 Boehringer Ingelheim Investigational Site
🇲🇾Putrajaya, Malaysia
1288.18.63008 Boehringer Ingelheim Investigational Site
🇵🇭Quezon City, Philippines
1288.18.84003 Boehringer Ingelheim Investigational Site
🇻🇳Hanoi, Vietnam
1288.18.60005 Boehringer Ingelheim Investigational Site
🇲🇾Negeri Sembilan, Malaysia
1288.18.63006 Boehringer Ingelheim Investigational Site
🇵🇭Surigao, Philippines
1288.18.63001 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
1288.18.86036 Boehringer Ingelheim Investigational Site
🇨🇳Nanjing, China