Empagliflozin Add on to Linagliptin Study in Japanese Patient With Type 2 Diabetes Mellitus
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT02453555
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This trial will compare the use of fixed dose combination of empagliflozin and linagliptin to linagliptin alone in patient with type 2 diabetes mellitus
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linagliptin placebo Empagliflozin + linagliptin high dose - Empagliflozin + linagliptin high dose Empagliflozin + linagliptin high dose patient to receive one tablet once daily Linagliptin Linagliptin patient to receive 5 mg linagliptin once daily Linagliptin Empagliflozin placebo + linagliptin placebo low dose patient to receive 5 mg linagliptin once daily Linagliptin Empa + lina highdose placebo patient to receive 5 mg linagliptin once daily Empagliflozin + linagliptin low dose Empagliflozin + linagliptin low dose patient to receive one tablet once daily Empagliflozin + linagliptin low dose Linagliptin placebo patient to receive one tablet once daily Empagliflozin + linagliptin high dose Linagliptin placebo patient to receive one tablet once daily Linagliptin placebo Empagliflozin + linagliptin low dose - Linagliptin placebo Linagliptin placebo - Empagliflozin + linagliptin high dose placebo Linagliptin - Empagliflozin + linagliptin high dose placebo Empa + lina highdose placebo - Empagliflozin + linagliptin low dose placebo Linagliptin - Empagliflozin + linagliptin low dose placebo Empagliflozin placebo + linagliptin placebo low dose -
- Primary Outcome Measures
Name Time Method Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline) Baseline and 24 week Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
- Secondary Outcome Measures
Name Time Method Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only) 28 Week (pre up-titration) and 52 Week Change from Week 28 in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at Week 28. Week 28 (pre up-titration) is referred to the last observed measurement prior to the first administration of any double-blind randomized trial medication in the up-titration period. Adjusted mean (Least square mean) and its standard error (SE) is presented.
This endpoint was based on 1 group of the Full analysis set with up-titration (FASUT-II) whose dose was up-titrated to Empagliflozin 25 mg/Linagliptin 5 mg fixed dose combination thus there is no comparison group. Hence, no comparison is made. A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline eGFR, prior use of antidiabetic drug, visit as fixed effect(s). The covariance used to fit the model was unstructured.Change in HbA1c From Baseline at Week 52 (All Empagliflozin Versus All Placebo) Baseline and 52 week Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus Linagliptin 5 mg + Placebo 25 mg) Baseline and 52 week Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus All Placebo) Baseline and 52 week Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Trial Locations
- Locations (40)
Nagoya Kyoritsu Hospital
🇯🇵Aichi, Nagoya, Japan
Kashiwa City Hospital
🇯🇵Chiba, Kashiwa, Japan
Otabe internal medicine clinic
🇯🇵Fukuoka, Fukuoka, Japan
Nakamura Cardiovascular Clinic
🇯🇵Fukuoka, Itoshima, Japan
Tanaka I.M. Clinic, Fukuoka, I.M.
🇯🇵Fukuoka, Kurume, Japan
Seino I.M. Clinic, Fukushima, I.M.
🇯🇵Fukushima, Koriyama, Japan
Hiraoka Naika Clinic, Hiroshima, I.M.
🇯🇵Hiroshima, Hiroshima, Japan
Matsuda Cardiovascular Clinic
🇯🇵Hokkaido, Sapporo, Japan
Teine Keijinkai Clinic
🇯🇵Hokkaido, Sapporo, Japan
Mita Internal Medicine Cardiology Clinic
🇯🇵Hokkaido, Sapporo, Japan
Scroll for more (30 remaining)Nagoya Kyoritsu Hospital🇯🇵Aichi, Nagoya, Japan