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

NCT04233801 | Completed Phase 3 Results

• 1 other identifier: 1245-0191
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 24

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24

  A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including treatment, background therapy, and visit as fixed classification effects, baseline HbA1c and baseline estimated glomerular filtration rate (eGFR) as the linear covariates, treatment by visit interaction, and baseline HbA1c by visit interaction.

  At baseline (Week 0) and at Week 24

Secondary Outcomes (8)

• Percentage of Participants With HbA1c<7.0% at Week 24

  At Week 24

• Change in Body Weight From Baseline to Week 24

  At baseline (Week 0) and at Week 24

• Change From Baseline in Systolic Blood Pressure (SBP) at Week 24

  At baseline (Week 0) and at Week 24

• Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24

  At baseline (Week 0) and at Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  At baseline (Week 0) and at Week 24

Study Arms (3)

Empagliflozin 10 mg

EXPERIMENTAL

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.

Drug: Empagliflozin

Empagliflozin 25 mg

EXPERIMENTAL

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.

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Empagliflozin DRUG

Empagliflozin

Empagliflozin 10 mg; Empagliflozin 25 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (24)

Peking University First Hospital

Beijing, 100034, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Beijing Pinggu Hospital

Beijing, 101200, China

Location

The Second Hospital of Jilin University

Changchun, 130041, China

Location

The third xiangya hospital of Central South University

Changsha, 410013, China

Location

The First Hospital, Chongqing Medical University

Chongqing, 400042, China

Location

Chongqing Three Gorges Central Hospital

Chongqing, 404000, China

Location

Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510150, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Hangzhou, 210011, China

Location

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, 310015, China

Location

Anhui Provincial Hospital

Hefei, 230001, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, 471000, China

Location

Jiangxi Provincial People's Hospital

Nanchang, 330006, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, 330006, China

Location

The Second Affiliated Hospital to Nanchang University

Nanchang, 330006, China

Location

The affiliated hospital of medicalcollege qingdao university

Qingdao, 266005, China

Location

Tongren hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200051, China

Location

Centre Hospital of Putuo District, Shanghai

Shanghai, 200062, China

Location

Shanghai Fifth People's Hospital affiliated to Fudan University

Shanghai, 200240, China

Location

Shengjing Hospital of China Medical University

Shenyang, 110072, China

Location

Suzhou Municipal Hospital

Suzhou, 215002, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

Tianjin Medical University Chu Hisen-I Memorial Hospital

Tianjin, 300070, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 18, 2020
• Study Start: April 15, 2020
• Primary Completion: March 3, 2022
• Study Completion: March 10, 2022
• Last Updated: December 15, 2023
• Results First Posted: December 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

CN (24)