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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| empagliflozin 10 mg | Experimental |
| |
| empagliflozin 25 mg | Experimental |
| |
| placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. | The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment. The term "baseline" refers to the last observation prior to the administration of any randomised study drug. Means presented are the adjusted means. | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs) | Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented | From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nakayama Clinic | Aichi | 456-0058 | Japan | |||
| Kashiwa City Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35472672 | Derived | Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034. |
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Patients who successfully completed the periods and who still satisfied the inclusion/exclusion criteria were randomised to the 52-week double- blind treatment period of the study in which they received either 1 of the 2 doses of empagliflozin or placebo in addition to insulin.
After screening, patients who were pre-treated with insulin and 1 oral antidiabetic drug (OAD) underwent a 10-week wash-out period.
Then patients proceeded to a 2-week open-label placebo run-in period. Patients who were pre-treated with insulin alone skipped the wash-out period and proceeded to an open-label placebo run-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients were orally administered Placebo matching Empagliflozin 10 milligram (mg) or 25 mg once daily for 52 weeks of double-blind treatment period |
| FG001 | Empagliflozin 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 13, 2016 | Dec 10, 2018 |
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| Drug |
|
| Placebo | Drug | For blinding purposes |
|
| Chiba, Kashiwa |
| 277-0825 |
| Japan |
| Kunisaki Makoto Clinic | Fukuoka | 819-0168 | Japan |
| Saiseikai Fukuoka General Hospital | Fukuoka, Fukuoka | 810-0001 | Japan |
| Seiwakai Medical Corporation Nagata Hospital | Fukuoka, Yanagawa | 832-0059 | Japan |
| Saiseikai Maebashi Hospital | Gunma, Maebashi | 371-0821 | Japan |
| Nippon Kokan Fukuyama Hospital | Hiroshima, Fukuyama | 721-0927 | Japan |
| Jiyugaoka Yokoyama Naika Clinic | Hokkaido, Obihiro | 080-0016 | Japan |
| Jiyugaoka Yamada Clinic | Hokkaido, Obihiro | 080-0848 | Japan |
| Souen Diabetes Clinic | Hokkaido, Sapporo | 060-0011 | Japan |
| Kotani Diabetes Clinic | Hyogo, Kobe | 657-0028 | Japan |
| Nishinomiya Municipal Central Hospital | Hyogo, Nishinomiya | 663-8014 | Japan |
| Noritake Clinic | Ibaraki, Ushiku | 300-1207 | Japan |
| Yokoi Medical Clinic, Kagawa, I.M. | Kagawa | 761-8075 | Japan |
| Fukumoto clinic | Kagoshima | 891-0401 | Japan |
| Izuro Imamura Hospital | Kagoshima, Kagoshima | 892-0824 | Japan |
| Wakamatsu Memorial Hospital | Kagoshima, Satsumasendai | 895-0052 | Japan |
| STOP DM SUZUKI DIABETES CLINIC, Kanagawa, I.M. | Kanagawa, Atsugi | 243-0035 | Japan |
| Takai Naika Clinic | Kanagawa, Kamakura | 247-0056 | Japan |
| Kokan Clinic | Kanagawa, Kawasaki | 210-0852 | Japan |
| Yoshimasa Diabetes & Endocrine Clinic | Kyoto, Kyoto | 604-8151 | Japan |
| Medical Corporation KEISEIKAI Kajiyama clinic | Kyoto, Kyoto | 615-0035 | Japan |
| Saka General Clinic | Miyagi, Tagajo | 985-0835 | Japan |
| North Alps Medical Center Azumi Hospital | Nagano, Kitaazumi-gun | 399-8695 | Japan |
| Asama Nanroku Komoro Medical center | Nagano, Komoro | 384-8588 | Japan |
| Abe Clinic | Oita, Oita | 870-0039 | Japan |
| Tsuyama Chuo Hospital | Okayama, Tsuyama | 708-0841 | Japan |
| AMC Nishi-umeda Clinic | Osaka | 530-0001 | Japan |
| Shiraiwa Medical Clinic | Osaka | 582-0005 | Japan |
| Medical Corporation Kyojinkai Clinic Komatsu | Osaka, Neyagawa | 572-8567 | Japan |
| Minamiosaka Hospital | Osaka, Osaka | 559-0012 | Japan |
| OCROM Clinic | Osaka, Suita | 565-0853 | Japan |
| Ageo Central General Hospital | Saitama, Ageo | 362-8588 | Japan |
| Medical Corporation Kaishinkai Masunaga Clinic | Saitama, Fujimi | 354-0031 | Japan |
| Medical Corporation Fusa Shimizu Clinic Fusa | Saitama, Saitama | 336-0963 | Japan |
| Seiwa Clinic | Tokyo, Adachi-ku | 123-0845 | Japan |
| Juntendo University Hospital | Tokyo, Bunkyo-ku | 113-8431 | Japan |
| Chiyoda Houjin Clinic | Tokyo, Chiyoda-ku | 101-0024 | Japan |
| HDC Atlas Clinic | Tokyo, Chiyoda-ku | 102-0082 | Japan |
| Fukuwa Clinic | Tokyo, Chuo-ku | 103-0027 | Japan |
| Tokyo-Eki Center-building Clinic | Tokyo, Chuo-ku | 103-0027 | Japan |
| Tokyo Center Clinic | Tokyo, Chuo-ku | 103-0028 | Japan |
| Shin Clinic | Tokyo, Ota-ku | 144-0051 | Japan |
| Shinjuku Research Park Clinic | Tokyo, Shinjuku-ku | 169-0073 | Japan |
| Sumida Chuou Hospital | Tokyo, Sumida-ku | 131-0046 | Japan |
| Sagae City Hospital | Yamagata, Sagae | 991-8508 | Japan |
| Clinic Sugiyama | Yamagata, Yamagata | 990-0885 | Japan |
| Yamanashi Prefectural Central Hospital | Yamanashi, Kofu | 400-8506 | Japan |
Patients were orally administered Empagliflozin 10 mg film-coated tablet once daily for 52 weeks of double-blind treatment period
| FG002 | Empagliflozin 25 mg | Patients were orally administered Empagliflozin 25 mg film-coated tablet once daily for 52 weeks of double-blind treatment period |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline measurement of the primary endpoint.
(The treated set (TS) consisted of all randomised patients who were treated with at least 1 dose of the study drug during the 52-week double blind treatment period. The TS was the basis for safety analyses)
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| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin 10 mg | Patients were orally administered Empagliflozin 10 mg film-coated tablet once daily for 52 weeks of double-blind treatment period |
| BG001 | Empagliflozin 25 mg | Patients were orally administered Empagliflozin 25 mg film-coated tablet once daily for 52 weeks of double-blind treatment period |
| BG002 | Placebo | Patients were orally administered Placebo matching Empagliflozin 10 milligram (mg) or 25 mg once daily for 52 weeks of double-blind treatment period |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Baseline glycosylated haemoglobin A1c (HbA1c) [%] | Mean | Standard Deviation | % of HbA1c |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. | The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment. The term "baseline" refers to the last observation prior to the administration of any randomised study drug. Means presented are the adjusted means. | Full analysis set (FAS) with last observation carried forward at 16 weeks (LOCF)-16; The FAS consisted of all patients in the TS who had a baseline measurement of the primary endpoint. | Posted | Mean | Standard Error | percentage of HbA1c | Baseline and 16 weeks |
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| Secondary | Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs) | Percentage of patients with investigator defined drug-related Adverse Events (AEs) are presented | Treated set (TS): TS consisted of all randomised patients who were treated with at least 1 dose of the study drug during the 52-week double blind treatment period. The TS was the basis for safety analyses. | Posted | Number | Percentage of participants | From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks |
|
From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Patients were orally administered Placebo matching Empagliflozin 10 milligram (mg) or 25 mg once daily for 52 weeks of double-blind treatment period | 0 | 90 | 6 | 90 | 49 | 90 |
| EG001 | Empagliflozin 10 mg | Patients were orally administered Empagliflozin 10 mg film-coated tablet once daily for 52 weeks of double-blind treatment period | 1 | 86 | 9 | 86 | 45 | 86 |
| EG002 | Empagliflozin 25 mg | Patients were orally administered Empagliflozin 25 mg film-coated tablet once daily for 52 weeks of double-blind treatment period | 0 | 90 | 8 | 90 | 48 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Vocal cord paralysis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyschromatopsia | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Asymptomatic bacteriuria | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Blood ketone body increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2017 | Dec 10, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo) |
| The statistical model was: Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error | ANCOVA | Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment | <0.0001 | Mean Difference (Final Values) | -1.00 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -1.18 | -0.82 | Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo) | Superiority | The superiority of empagliflozin 25 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided) |
| Units | Counts |
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| Participants |
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