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Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
empagliflozin 10 mg + linagliptin 5 mg
empagliflozin 10 mg
empagliflozin 25 mg + linagliptin 5 mg
empagliflozin 25 mg
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Diagnosis of type 2 diabetes prior to informed consent

  • Male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are:

    • drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
    • pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). Individual antidiabetic drug will have to be discontinued at Visit 1.

  • haemoglobin A1c (HbA1c) at Visit 1 (screening)

    • for patients without antidiabetic therapy : HbA1c >=8.0 to =<10.5%
    • for patients with one oral antidiabetic drug : HbA1c >=7.5 to =<10.5%
  • HbA1c >=7.5 to =<10.0% at Visit 4 for randomisation into the double blind treatment period

Exclusion criteria:

  • Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15.0 mmol/L) during the open label stabilisation period and placebo run in period
  • Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (modification of diet in renal disease (MDRD) formula)
  • Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
  • Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Sites / Locations

  • Tokai Memorial Hospital
  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
  • Tokuyama Clinic
  • Matsuyama Shimin Hospital
  • Tanaka Int. Clinic, Ehime, DIA Med.,CV Med.
  • Murakami Memorial Hp., Ehime, I.M.
  • Kunisaki Makoto Clinic, Fukuoka, I.M./CV Med.
  • Fukuoka Shin Mizumaki Hospital
  • Shin Yukuhashi Hospital
  • Hashimoto I.M., Gifu, I.M.
  • Kikuchi Naika Clinic, Gunma, I.M.
  • Hasegawa Internal Medicine Clinic
  • Ebetsu Internal Medicine Clinic
  • Hakodate Koseiin Hakodate Central General Hospital
  • Iida Medical Clinic
  • Kurihara Clinic
  • Uehara Clinic
  • Manda Memorial Hospital
  • Sapporo Diabetes, Thyroid Clinic
  • Japan Community Health Care Organization Hokkaido Hospital
  • Ashiya Municipal Hospital
  • Itabashi DIA Med. and DERM Clinic, Ibaraki, I.M.
  • Namegata District General Hospital
  • Hokuriku Hp., Ishikawa, I.M.
  • Oikawa Clinic
  • Hirano Medical Clinic
  • Iwamoto Clinic, Kagawa, DIAB I.M.
  • Tenpozan Clinic of I.M., Kagoshima, I.M.
  • Hayashi DIA Clinic, Kanagawa, DIA Tract Med.·I.M.
  • Takai Naika Clinic
  • Nagatsuta Family Clinic, Kanagawa, I.M.
  • Motomachi Takatsuka Naika Clinic, Kanagawa, I.M.
  • Yokohama Minoru Clinic
  • Morinagaueno clinic, Kumamoto, Digestive Tract I.M.
  • Kumamoto University Hospital
  • Jinnouchi Clinic Diabetes Care Center
  • Kajiyama Clinic, Kyoto, I.M.
  • Matsumoto Nakagawa Hospital
  • Ota DIA I.M. Clinic, Nagano, I.M.
  • Saiseikai Niigata Daini Hp., Niigata, METAB ENDO
  • Tsuyama Chuo Hospital
  • Yaesu Clinic, Okinawa, I.M.
  • Tanaka Clinic, Okinawa, I.M.
  • Umeda Oak Clinic, Osaka, I.M.
  • Kinugawa CARDIOL Clinic, Osaka, I.M.
  • Ikeoka Clinic, Osaka, I.M.
  • Nanko Clinic, Osaka, I.M.
  • OCROM Clinic
  • AMC Nishi-umeda Clinic
  • Shiraiwa Medical Clinic, Osaka, I.M.
  • Saga Memorial Hospital
  • Odayaka Life Naika Clinic, Saitama, I.M.
  • Medical corporation Chisei-kai Watanabe clinic
  • Medical Corporation Toujinkai Sakado Central Hospital
  • SAINO Clinic,
  • Hamamatsu Rosai Hospital
  • Plumeria Clinic, Shizuoka, I.M.
  • Wakakusa Clinic, Tochigi, I.M.
  • Nihonbashi Sakura Clinic
  • Fukuwa Clinic
  • Nihonbashi Enomoto Internal Medicine
  • Tokyo-Eki Center-building Clinic
  • Tokyo Center Clinic
  • Hosono Clinic
  • AGE Makita Medical Clinic
  • Kasai Diabetes Clinic
  • New Medical Research System Clinic
  • Medical Corporation Keikokai P1-Clinic
  • Minamino Heart Clinic
  • Shinkoiwa Ekimae Sougou Clinic
  • Musashino Polyclinic
  • Pedi Shiodome Clinic
  • Shinagawa East one Medical Clinic
  • Shimamura Kinen Hospital
  • Kenkoukan Suzuki Clinic
  • Honda Hidehiko Clinic
  • Sakayori Clinic
  • Miho Clinic
  • ToCROM Clinic
  • Ikebukuro Metropolitan Clinic
  • Kanda Clinic, Tokyo, I.M.
  • Fujikoshi Hp., Toyama, I.M.
  • Clinic Sugiyama, Yamagata, I.M.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

empagliflozin 10 mg + linagliptin 5 mg

empagliflozin 10 mg

empagliflozin 25 mg + linagliptin 5 mg

empagliflozin 25 mg

Arm Description

patient to receive a tablet containing low dose empagliflozin and linagliptin once daily

patient to receive a tablet containing low dose empagliflozin once daily

patient to receive a tablet containing high dose empagliflozin and linagliptin once daily

patients to receive a tablet containing high dose empagliflozin once daily

Outcomes

Primary Outcome Measures

Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment
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

Full Information

First Posted
May 27, 2015
Last Updated
September 3, 2018
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02489968
Brief Title
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
Official Title
A Phase III, Randomised, Double-blind, Parallel Group, 24-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 10 mg Plus Placebo and a 52-week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 25 mg and Linagliptin 5 mg Fixed Dose Combination Compared With Empagliflozin 25 mg Plus Placebo in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16-week Treatment With Empagliflozin (10 mg or 25 mg) Alone Once Daily.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 12, 2015 (Actual)
Primary Completion Date
November 18, 2016 (Actual)
Study Completion Date
June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
880 (Actual)

8. Arms, Groups, and Interventions

Arm Title
empagliflozin 10 mg + linagliptin 5 mg
Arm Type
Experimental
Arm Description
patient to receive a tablet containing low dose empagliflozin and linagliptin once daily
Arm Title
empagliflozin 10 mg
Arm Type
Experimental
Arm Description
patient to receive a tablet containing low dose empagliflozin once daily
Arm Title
empagliflozin 25 mg + linagliptin 5 mg
Arm Type
Experimental
Arm Description
patient to receive a tablet containing high dose empagliflozin and linagliptin once daily
Arm Title
empagliflozin 25 mg
Arm Type
Experimental
Arm Description
patients to receive a tablet containing high dose empagliflozin once daily
Intervention Type
Drug
Intervention Name(s)
empagliflozin 10 mg + linagliptin 5 mg
Intervention Description
empagliflozin low dose + linagliptin once daily
Intervention Type
Drug
Intervention Name(s)
empagliflozin 10 mg
Intervention Description
empagliflozin low dose once daily
Intervention Type
Drug
Intervention Name(s)
empagliflozin 25 mg + linagliptin 5 mg
Intervention Description
empagliflozin high dose + linagliptin once daily
Intervention Type
Drug
Intervention Name(s)
empagliflozin 25 mg
Intervention Description
empagliflozin high dose once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment
Description
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.
Time Frame
Baseline and 24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of type 2 diabetes prior to informed consent Male and female patients on diet and exercise regimen for at least 12 weeks prior to informed consent who are: drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or, pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to half of the maximum approved dose) on stable dosage for at least 12 weeks prior to the informed consent (for thiazolidinedione, therapy has to be unchanged for at least 18 weeks prior to the informed consent). Individual antidiabetic drug will have to be discontinued at Visit 1. haemoglobin A1c (HbA1c) at Visit 1 (screening) for patients without antidiabetic therapy : HbA1c >=8.0 to =<10.5% for patients with one oral antidiabetic drug : HbA1c >=7.5 to =<10.5% HbA1c >=7.5 to =<10.0% at Visit 4 for randomisation into the double blind treatment period Exclusion criteria: Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15.0 mmol/L) during the open label stabilisation period and placebo run in period Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (modification of diet in renal disease (MDRD) formula) Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Tokai Memorial Hospital
City
Aichi, Kasugai
ZIP/Postal Code
487-0031
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital
City
Aichi, Nagoya
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Tokuyama Clinic
City
Chiba, Chiba
ZIP/Postal Code
261-0004
Country
Japan
Facility Name
Matsuyama Shimin Hospital
City
Ehime, Matsuyama
ZIP/Postal Code
790-0067
Country
Japan
Facility Name
Tanaka Int. Clinic, Ehime, DIA Med.,CV Med.
City
Ehime, Niihama
ZIP/Postal Code
792-0045
Country
Japan
Facility Name
Murakami Memorial Hp., Ehime, I.M.
City
Ehime, Saijo
ZIP/Postal Code
793-0030
Country
Japan
Facility Name
Kunisaki Makoto Clinic, Fukuoka, I.M./CV Med.
City
Fukuoka, Fukuoka
ZIP/Postal Code
819-0168
Country
Japan
Facility Name
Fukuoka Shin Mizumaki Hospital
City
Fukuoka, Onga
ZIP/Postal Code
807-0051
Country
Japan
Facility Name
Shin Yukuhashi Hospital
City
Fukuoka, Yukuhashi
ZIP/Postal Code
824-0026
Country
Japan
Facility Name
Hashimoto I.M., Gifu, I.M.
City
Gifu, Gifu
ZIP/Postal Code
500-8225
Country
Japan
Facility Name
Kikuchi Naika Clinic, Gunma, I.M.
City
Gunma, Maebashi
ZIP/Postal Code
370-3573
Country
Japan
Facility Name
Hasegawa Internal Medicine Clinic
City
Hokkaido, Chitose
ZIP/Postal Code
066-0032
Country
Japan
Facility Name
Ebetsu Internal Medicine Clinic
City
Hokkaido, Ebetsu
ZIP/Postal Code
067-0041
Country
Japan
Facility Name
Hakodate Koseiin Hakodate Central General Hospital
City
Hokkaido, Hakodate
ZIP/Postal Code
040-8585
Country
Japan
Facility Name
Iida Medical Clinic
City
Hokkaido, Hakodate
ZIP/Postal Code
042-0942
Country
Japan
Facility Name
Kurihara Clinic
City
Hokkaido, Sapporo
ZIP/Postal Code
004-0053
Country
Japan
Facility Name
Uehara Clinic
City
Hokkaido, Sapporo
ZIP/Postal Code
006-0031
Country
Japan
Facility Name
Manda Memorial Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-0062
Country
Japan
Facility Name
Sapporo Diabetes, Thyroid Clinic
City
Hokkaido, Sapporo
ZIP/Postal Code
060-0807
Country
Japan
Facility Name
Japan Community Health Care Organization Hokkaido Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
062-8618
Country
Japan
Facility Name
Ashiya Municipal Hospital
City
Hyogo, Ashiya
ZIP/Postal Code
659-8502
Country
Japan
Facility Name
Itabashi DIA Med. and DERM Clinic, Ibaraki, I.M.
City
Ibaraki, Koga
ZIP/Postal Code
306-0232
Country
Japan
Facility Name
Namegata District General Hospital
City
Ibaraki, Namegata
ZIP/Postal Code
311-3516
Country
Japan
Facility Name
Hokuriku Hp., Ishikawa, I.M.
City
Ishikawa, Kanazawa
ZIP/Postal Code
921-8035
Country
Japan
Facility Name
Oikawa Clinic
City
Iwate, Morioka
ZIP/Postal Code
020-0066
Country
Japan
Facility Name
Hirano Medical Clinic
City
Iwate, Morioka
ZIP/Postal Code
020-0132
Country
Japan
Facility Name
Iwamoto Clinic, Kagawa, DIAB I.M.
City
Kagawa, Zentsuji
ZIP/Postal Code
765-0071
Country
Japan
Facility Name
Tenpozan Clinic of I.M., Kagoshima, I.M.
City
Kagoshima, Kagoshima
ZIP/Postal Code
890-0061
Country
Japan
Facility Name
Hayashi DIA Clinic, Kanagawa, DIA Tract Med.·I.M.
City
Kanagawa, Chigasaki
ZIP/Postal Code
253-0044
Country
Japan
Facility Name
Takai Naika Clinic
City
Kanagawa, Kamakura
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Nagatsuta Family Clinic, Kanagawa, I.M.
City
Kanagawa, Yokohama
ZIP/Postal Code
226-0027
Country
Japan
Facility Name
Motomachi Takatsuka Naika Clinic, Kanagawa, I.M.
City
Kanagawa, Yokohama
ZIP/Postal Code
231-0023
Country
Japan
Facility Name
Yokohama Minoru Clinic
City
Kanagawa, Yokohama
ZIP/Postal Code
232-0064
Country
Japan
Facility Name
Morinagaueno clinic, Kumamoto, Digestive Tract I.M.
City
Kumamoto, Kumamoto
ZIP/Postal Code
860-0863
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Jinnouchi Clinic Diabetes Care Center
City
Kumamoto, Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Kajiyama Clinic, Kyoto, I.M.
City
Kyoto, Kyoto
ZIP/Postal Code
615-0035
Country
Japan
Facility Name
Matsumoto Nakagawa Hospital
City
Nagano, Matsumoto
ZIP/Postal Code
399-0006
Country
Japan
Facility Name
Ota DIA I.M. Clinic, Nagano, I.M.
City
Nagano, Nagano
ZIP/Postal Code
380-0802
Country
Japan
Facility Name
Saiseikai Niigata Daini Hp., Niigata, METAB ENDO
City
Niigata, Niigata
ZIP/Postal Code
950-1104
Country
Japan
Facility Name
Tsuyama Chuo Hospital
City
Okayama, Tsuyama
ZIP/Postal Code
708-0841
Country
Japan
Facility Name
Yaesu Clinic, Okinawa, I.M.
City
Okinawa, Naha
ZIP/Postal Code
900-0032
Country
Japan
Facility Name
Tanaka Clinic, Okinawa, I.M.
City
Okinawa, Tomigusuku
ZIP/Postal Code
901-0244
Country
Japan
Facility Name
Umeda Oak Clinic, Osaka, I.M.
City
Osaka, Osaka
ZIP/Postal Code
530-0057
Country
Japan
Facility Name
Kinugawa CARDIOL Clinic, Osaka, I.M.
City
Osaka, Osaka
ZIP/Postal Code
532-0026
Country
Japan
Facility Name
Ikeoka Clinic, Osaka, I.M.
City
Osaka, Osaka
ZIP/Postal Code
536-0008
Country
Japan
Facility Name
Nanko Clinic, Osaka, I.M.
City
Osaka, Osaka
ZIP/Postal Code
559-0011
Country
Japan
Facility Name
OCROM Clinic
City
Osaka, Suita
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
AMC Nishi-umeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Shiraiwa Medical Clinic, Osaka, I.M.
City
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Facility Name
Saga Memorial Hospital
City
Saga, Saga
ZIP/Postal Code
849-0917
Country
Japan
Facility Name
Odayaka Life Naika Clinic, Saitama, I.M.
City
Saitama, Koshigaya
ZIP/Postal Code
343-0828
Country
Japan
Facility Name
Medical corporation Chisei-kai Watanabe clinic
City
Saitama, Okegawa
ZIP/Postal Code
363-0022
Country
Japan
Facility Name
Medical Corporation Toujinkai Sakado Central Hospital
City
Saitama, Sakado
ZIP/Postal Code
350-0233
Country
Japan
Facility Name
SAINO Clinic,
City
Saitama, Tokorozawa
ZIP/Postal Code
359-1141
Country
Japan
Facility Name
Hamamatsu Rosai Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
430-8525
Country
Japan
Facility Name
Plumeria Clinic, Shizuoka, I.M.
City
Shizuoka, Shizuoka
ZIP/Postal Code
422-8006
Country
Japan
Facility Name
Wakakusa Clinic, Tochigi, I.M.
City
Tochigi, Shimotsuke
ZIP/Postal Code
329-0433
Country
Japan
Facility Name
Nihonbashi Sakura Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0025
Country
Japan
Facility Name
Fukuwa Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Nihonbashi Enomoto Internal Medicine
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Tokyo-Eki Center-building Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Tokyo Center Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Hosono Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
AGE Makita Medical Clinic
City
Tokyo, Chuo-ku
ZIP/Postal Code
104-0061
Country
Japan
Facility Name
Kasai Diabetes Clinic
City
Tokyo, Edogawa-ku
ZIP/Postal Code
134-0084
Country
Japan
Facility Name
New Medical Research System Clinic
City
Tokyo, Hachioji
ZIP/Postal Code
192-0046
Country
Japan
Facility Name
Medical Corporation Keikokai P1-Clinic
City
Tokyo, Hachioji
ZIP/Postal Code
192-0071
Country
Japan
Facility Name
Minamino Heart Clinic
City
Tokyo, Hachioji
ZIP/Postal Code
192-0918
Country
Japan
Facility Name
Shinkoiwa Ekimae Sougou Clinic
City
Tokyo, Katushika-ku
ZIP/Postal Code
124-0024
Country
Japan
Facility Name
Musashino Polyclinic
City
Tokyo, Kiyose
ZIP/Postal Code
204-0021
Country
Japan
Facility Name
Pedi Shiodome Clinic
City
Tokyo, Minato-ku
ZIP/Postal Code
105-7390
Country
Japan
Facility Name
Shinagawa East one Medical Clinic
City
Tokyo, Minato-ku
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Shimamura Kinen Hospital
City
Tokyo, Nerima-ku
ZIP/Postal Code
177-0051
Country
Japan
Facility Name
Kenkoukan Suzuki Clinic
City
Tokyo, Ota-ku
ZIP/Postal Code
143-0015
Country
Japan
Facility Name
Honda Hidehiko Clinic
City
Tokyo, Ota-ku
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Sakayori Clinic
City
Tokyo, Shinagawa-ku
ZIP/Postal Code
140-0011
Country
Japan
Facility Name
Miho Clinic
City
Tokyo, Shinagawa-ku
ZIP/Postal Code
141-0032
Country
Japan
Facility Name
ToCROM Clinic
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
160-0022
Country
Japan
Facility Name
Ikebukuro Metropolitan Clinic
City
Tokyo, Toshima-ku
ZIP/Postal Code
171-0021
Country
Japan
Facility Name
Kanda Clinic, Tokyo, I.M.
City
Tokyo
ZIP/Postal Code
101-0047
Country
Japan
Facility Name
Fujikoshi Hp., Toyama, I.M.
City
Toyama, Toyama
ZIP/Postal Code
930-0964
Country
Japan
Facility Name
Clinic Sugiyama, Yamagata, I.M.
City
Yamagata, Yamagata
ZIP/Postal Code
990-0885
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30091172
Citation
Kaku K, Haneda M, Tanaka Y, Lee G, Shiki K, Miyamoto Y, Solimando F, Lee J, Lee C, George J. Linagliptin as add-on to empagliflozin in a fixed-dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a two-part, randomized, placebo-controlled trial. Diabetes Obes Metab. 2019 Jan;21(1):136-145. doi: 10.1111/dom.13496. Epub 2018 Sep 6.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Synopsis Link

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Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus

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