Clinical trial NCT04233801: A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin
Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Empagliflozin (10 mg and 25 mg) Administered Orally Once Daily in Combination With Insulin With or Without up to Two Oral Anti-diabetic Agents for 24 Weeks in Chinese Type 2 Diabetic Patients With Insufficient Glycemic Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study in Chinese adults with type 2 diabetes. The study is open to people who take insulin but still have too high blood sugar levels. Participants may additionally be taking up to 2 other medicines for their diabetes. The purpose of this study is to find out whether empagliflozin taken together with insulin helps people with type 2 diabetes to better control their blood sugar.

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years and ≤75 years old at Visit 1;
* 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:

* Diagnosis of Type 1 diabetes;
* 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24
timeFrame: At baseline (Week 0) and at Week 24
Secondary outcomes:
measure: Percentage of Participants With HbA1c<7.0% at Week 24
timeFrame: At Week 24
measure: Change in Body Weight From Baseline to Week 24
timeFrame: At baseline (Week 0) and at Week 24
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 24
timeFrame: At baseline (Week 0) and at Week 24
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24
timeFrame: At baseline (Week 0) and at Week 24
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
timeFrame: At baseline (Week 0) and at Week 24
measure: Change From Baseline in 2-hour Post-prandial Glucose (PPG) at Week 24
timeFrame: At baseline (Week 0) and at Week 24
measure: Number of Participants With Confirmed Hypoglycaemic Events
timeFrame: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
measure: Number of Participants With Adjudicated Diabetic Ketoacidosis (DKA) Events
timeFrame: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Changsha
country: China
facility: The third xiangya hospital of Central South University
city: Chongqing
country: China
facility: The First Hospital, Chongqing Medical University
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
city: Qingdao
country: China
facility: The affiliated hospital of medicalcollege qingdao university
city: Shanghai
country: China
facility: Tongren hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Centre Hospital of Putuo District, Shanghai
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital affiliated to Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Medical University Chu Hisen-I Memorial Hospital
Study officials:
References: