Diabetes Mellitus, Type 2Phase 3NCT04233801
A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin
A Phase 3 study testing Empagliflozin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 24 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 24 sitesChina
- Study dates
- 15 Apr 2020to 10 Mar 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
Peking University First Hospital
Beijing, 100034
Peking University People's Hospital
Beijing, 100044
Peking University Third Hospital
Beijing, 100191
Beijing Pinggu Hospital
Beijing, 101200
The Second Hospital of Jilin University
Changchun, 130041
The third xiangya hospital of Central South University
Changsha, 410013
The First Hospital, Chongqing Medical University
Chongqing, 400042
Chongqing Three Gorges Central Hospital
Chongqing, 404000
Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510150
The Second Affiliated Hospital of Nanjing Medical University
Hangzhou, 210011
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, 310015
Anhui Provincial Hospital
Hefei, 230001
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000
Jiangxi Provincial People's Hospital
Nanchang, 330006
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006
The affiliated hospital of medicalcollege qingdao university
Qingdao, 266005
Tongren hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200051
Centre Hospital of Putuo District, Shanghai
Shanghai, 200062
Shanghai Fifth People's Hospital affiliated to Fudan University
Shanghai, 200240
Shengjing Hospital of China Medical University
Shenyang, 110072
Suzhou Municipal Hospital
Suzhou, 215002
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Tianjin Medical University Chu Hisen-I Memorial Hospital
Tianjin, 300070
About this study
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.
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
- Being tested
- Empagliflozin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Empagliflozin
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (Week 0) and at Week 24
Secondary outcomes (8)
Percentage of Participants With HbA1c<7.0% at Week 24
Percentage of participants with glycosylated haemoglobin A1c (HbA1c) <7.0% at Week 24 is reported.
Measured: At Week 24
Change in Body Weight From Baseline to Week 24
Change in body weight from baseline to Week 24 is reported. A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline body weight, and its interaction with visit.
Measured: At baseline (Week 0) and at Week 24
Change From Baseline in Systolic Blood Pressure (SBP) at Week 24
A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline SBP and its interaction with visit.
Measured: At baseline (Week 0) and at Week 24
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24
A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline DBP and its interaction with visit.
Measured: At baseline (Week 0) and at Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied including baseline FPG and its interaction with visit.
Measured: At baseline (Week 0) and at Week 24
Change From Baseline in 2-hour Post-prandial Glucose (PPG) at Week 24
The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.
Measured: At baseline (Week 0) and at Week 24
Number of Participants With Confirmed Hypoglycaemic Events
Confirmed hypoglycemic events refer to the hypoglycaemic events with a plasma glucose value of ≤70 milligrams per deciliter (mg/dL) or where assistance was required.
Measured: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
Number of Participants With Adjudicated Diabetic Ketoacidosis (DKA) Events
The risk of DKA had to be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty in breathing, confusion, unusual fatigue or sleepiness. In case of a suspected DKA, the investigator was to ensure that appropriate tests were performed at the earliest opportunity according to 2017 China Type 2 diabetes mellitus (T2DM) guidelines.
An independent external Clinical event committee (CEC) was established to adjudicate centrally and in a blinded fashion events suspected of DKA and certain hepatic events.
DKA was investigated using both broad and narrow Boehringer Ingelheim customised MedDRA query (BIcMQs).
Measured: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Apr 2020
- Primary completion3 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233801
- Sponsor's protocol ID
- 1245-0191
- Status last verified
- Mar 2023
- First submitted
- 16 Jan 2020
- Last updated
- 15 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04233801
- Acronym / sponsor ID
- 1245-0191
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 15 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 10 mg | Experimental | Drug: Empagliflozin1 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 25 mg | Experimental | Drug: Empagliflozin1 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. |
| Placebo | Placebo comparator | Drug: PlaceboMatching 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- HbA1c ≥7.5% and ≤11.0% at Visit 1;
- Fasting C-peptide: >0.5 ng/mL (>166pmol/L) at Visit 1；
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinEmpagliflozin | Drug | Empagliflozin 10 mg, Empagliflozin 25 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24
Time frame: At baseline (Week 0) and 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.
8 secondary outcomes
Percentage of Participants With HbA1c<7.0% at Week 24
Time frame: At Week 24
Change in Body Weight From Baseline to Week 24
Time frame: At baseline (Week 0) and at Week 24
Change From Baseline in Systolic Blood Pressure (SBP) at Week 24
Time frame: At baseline (Week 0) and at Week 24
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 24
Time frame: At baseline (Week 0) and at Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: At baseline (Week 0) and at Week 24
Change From Baseline in 2-hour Post-prandial Glucose (PPG) at Week 24
Time frame: At baseline (Week 0) and at Week 24
Number of Participants With Confirmed Hypoglycaemic Events
Time frame: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
Number of Participants With Adjudicated Diabetic Ketoacidosis (DKA) Events
Time frame: From first administration of the initial randomised study medication to last intake of study medication + 7 days (inclusive), up to 176 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Empagliflozin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 24 (time frame: At baseline (Week 0) and at Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.