A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04233801
Collaborator
(none)
219
Enrollment
24
Locations
3
Arms
23.4
Anticipated Duration (Months)
9.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
219 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Apr 15, 2020
Anticipated Primary Completion Date :
Mar 21, 2022
Anticipated Study Completion Date :
Mar 28, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Empagliflozin low dose

Drug: Empagliflozin
Empagliflozin

Experimental: Empagliflozin high dose

Drug: Empagliflozin
Empagliflozin

Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. change from baseline in glycosylated haemoglobin A1c (HbA1c) [24 weeks]

Secondary Outcome Measures

  1. Percentage of patients with HbA1c<7.0% [24 weeks]

  2. Change in body weight [24 weeks]

  3. Change in systolic blood pressure (SBP) [24 weeks]

  4. Change in diastolic blood pressure (DBP) [24 weeks]

  5. Change in Fasting Plasma Glucose (FPG) [24 weeks]

  6. Change in 2-hour Post-prandial Glucose (PPG) [24 weeks]

  7. Occurrence of hypoglycemic events [28 weeks]

  8. Occurrence of adjudicated diabetic ketoacidosis (DKA) events [28 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Peking University First HospitalBeijingChina100034
2Peking University People's HospitalBeijingChina100044
3Peking University Third HospitalBeijingChina100191
4Beijing Pinggu HospitalBeijingChina101200
5The Second Hospital of Jilin UniversityChangchunChina130041
6The third xiangya hospital of Central South UniversityChangshaChina410013
7The First Hospital, Chongqing Medical UniversityChongqingChina400042
8Chongqing Three Gorges Central HospitalChongqingChina404000
9Third Affiliated Hospital of Guangzhou Medical UniversityGuangzhouChina510150
10The Second Affiliated Hospital of Nanjing Medical UniversityHangzhouChina210011
11The Affiliated Hospital of Hangzhou Normal UniversityHangzhouChina310015
12Anhui Provincial HospitalHefeiChina230001
13The First Affiliated Hospital of Henan University of Science and TechnologyLuoyangChina471000
14Jiangxi Provincial People's HospitalNanchangChina330006
15The First Affiliated Hospital of Nanchang UniversityNanchangChina330006
16The Second Affiliated Hospital to Nanchang UniversityNanchangChina330006
17The affiliated hospital of medicalcollege qingdao universityQingdaoChina266005
18Tongren hospital, Shanghai Jiaotong University School of MedicineShanghaiChina200051
19Centre Hospital of Putuo District, ShanghaiShanghaiChina200062
20Shanghai Fifth People's Hospital affiliated to Fudan UniversityShanghaiChina200240
21Shengjing Hospital of China Medical UniversityShenyangChina110072
22Suzhou Municipal HospitalSuzhouChina215002
23The First Affiliated Hospital of Soochow UniversitySuzhouChina215006
24Tianjin Medical University Chu Hisen-I Memorial HospitalTianjinChina300070

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04233801
Other Study ID Numbers:
  • 1245-0191
First Posted:
Jan 18, 2020
Last Update Posted:
Dec 3, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2021