A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin
NCT ID: NCT04233801
Last Updated: 2023-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
219 participants
INTERVENTIONAL
2020-04-15
2022-03-10
Brief Summary
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The participants are in the study for about 7 months. During this time, they visit the study site about 8 times, 1 additional visit may be either a visit to the study site or a phone call. At the start of the study, participants are put into 3 groups by chance. Participants get either 10 mg empagliflozin tablets, or 25 mg empagliflozin tablets, or placebo tablets once a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine.
The doctors regularly take blood samples from the participants. The changes in blood sugar levels are compared between the groups. The doctors also check the general health of the participants.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Empagliflozin 10 mg
1 table of 10 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks.
Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Empagliflozin
Empagliflozin
Empagliflozin 25 mg
1 table of 25 milligrams (mg) of Empagliflozin was administered orally once daily for a treatment period of 24 weeks.
Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Empagliflozin
Empagliflozin
Placebo
Matching placebo was administered orally once daily for a treatment period of 24 weeks.
Before the first dose of randomised drug, all participants went through a 2-week open label placebo run-in period, taking Placebo tablets orally once daily.
Placebo
Placebo
Interventions
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Empagliflozin
Empagliflozin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Chinese patient with diagnosis of Type 2 diabetes prior to Visit 1;
* A stable treatment with premixed Insulin (≥ 20IU/day) or basal insulin (≥ 16 IU/day) for at least 12 weeks prior to enrolment with or without up to two OADs
* With maximum insulin dose of ≤ 1 unit/kg/day. Acceptable basal insulins should have duration of action up to 24 h such as insulin Degludec, insulin glargin, insulin detemir or NPH (neutral protamine hagedorn) insulin; Acceptable pre-mixed insulins could be once or twice daily posology only. The total insulin dose should not be changed by more than 20% of the baseline value within the 12 weeks prior to randomisation (Visit 3). Both human insulin \& insulin analogue are acceptable;
* If the patient is taking OADs, regimen has to be unchanged for at least 12 weeks prior to randomization (Visit 3);
* If the patient is taking metformin, stable dose (at least 1500 mg daily or maximum tolerated dose) must be maintained for at least 12 weeks without dose adjustments prior to randomization (Visit 3);
* HbA1c ≥7.5% and ≤11.0% at Visit 1;
* Fasting C-peptide: \>0.5 ng/mL (\>166pmol/L) at Visit 1；
* 18.5 kg/m2 ≤ BMI ≤ 45 kg/m2 at Visit 1;
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial;
* Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion Criteria
* Patients receiving MDI insulin or insulin pump treatment;
* eGFR \<45ml/min/1.73m2 calculated based on MDRD formula;
* Uncontrolled hyperglycemia \[glucose level \>13. 9 mmol/l after an overnight fast during placebo run-in\];
* Severe hypoglycemia episode (event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions) within 6 months prior to Visit 1;
* History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. Myocardial infarction, stroke or transient ischaemic attack within 3 months prior to Visit 1;
* Bariatric surgery;
* Further criteria apply
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Beijing Pinggu Hospital
Beijing, , China
The Second Hospital of Jilin University
Changchun, , China
The third xiangya hospital of Central South University
Changsha, , China
The First Hospital, Chongqing Medical University
Chongqing, , China
Chongqing Three Gorges Central Hospital
Chongqing, , China
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
The Second Affiliated Hospital of Nanjing Medical University
Hangzhou, , China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, , China
Anhui Provincial Hospital
Hefei, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Jiangxi Provincial People's Hospital
Nanchang, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Affiliated Hospital to Nanchang University
Nanchang, , China
The affiliated hospital of medicalcollege qingdao university
Qingdao, , China
Tongren hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Centre Hospital of Putuo District, Shanghai
Shanghai, , China
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Suzhou Municipal Hospital
Suzhou, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Tianjin Medical University Chu Hisen-I Memorial Hospital
Tianjin, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1245-0191
Identifier Type: -
Identifier Source: org_study_id