Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02489968
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin. All analyses will be carried out separately for these study parts. The objective of Part A is to investigate the efficacy, safety and tolerability of the fixed dose combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM (Type 2 Diabetes Mellitus) who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 25 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be followed by a 28 week extension treatment period to evaluate further efficacy and safety up to 52 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 880
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description empagliflozin 10 mg + linagliptin 5 mg empagliflozin 10 mg + linagliptin 5 mg patient to receive a tablet containing low dose empagliflozin and linagliptin once daily empagliflozin 25 mg + linagliptin 5 mg empagliflozin 25 mg + linagliptin 5 mg patient to receive a tablet containing high dose empagliflozin and linagliptin once daily empagliflozin 10 mg empagliflozin 10 mg patient to receive a tablet containing low dose empagliflozin once daily empagliflozin 25 mg empagliflozin 25 mg patients to receive a tablet containing high dose empagliflozin once daily empagliflozin 10 mg Placebo patient to receive a tablet containing low dose empagliflozin once daily empagliflozin 25 mg Placebo patients to receive a tablet containing high dose empagliflozin once daily
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment Baseline and 24 week Change from baseline in HbA1c (%) after 24 weeks of treatment with double-blind trial medication. Change was calculated as: HbA1c value at 24-week - HbA1c value at baseline, for each patient. Baseline was defined as the last observation before the first intake of double-blind randomised trial medication. Statistical analysis presented is based on a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach. Full Analysis Set (Observed Cases) \[FAS (OC)\]: This analysis set consisted of all patients who were randomised and treated with at least 1 dose of trial drug during the double-blind part of the trial and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the 24-week double-blind part of the trial. Observed cases analysis included only the available data that were observed while patients were on treatment, i.e., excluding the missing data.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (83)
Tokai Memorial Hospital
🇯🇵Aichi, Kasugai, Japan
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
🇯🇵Aichi, Nagoya, Japan
Tokuyama Clinic
🇯🇵Chiba, Chiba, Japan
Matsuyama Shimin Hospital
🇯🇵Ehime, Matsuyama, Japan
Tanaka Int. Clinic, Ehime, DIA Med.,CV Med.
🇯🇵Ehime, Niihama, Japan
Murakami Memorial Hp., Ehime, I.M.
🇯🇵Ehime, Saijo, Japan
Kunisaki Makoto Clinic, Fukuoka, I.M./CV Med.
🇯🇵Fukuoka, Fukuoka, Japan
Fukuoka Shin Mizumaki Hospital
🇯🇵Fukuoka, Onga, Japan
Shin Yukuhashi Hospital
🇯🇵Fukuoka, Yukuhashi, Japan
Hashimoto I.M., Gifu, I.M.
🇯🇵Gifu, Gifu, Japan
Scroll for more (73 remaining)Tokai Memorial Hospital🇯🇵Aichi, Kasugai, Japan