Diabetes Mellitus, Type 2Phase 3NCT03851432
Janagliflozin Treat Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Metformin
A Phase 3 study testing Janagliflozin plus metformin in people with Diabetes Mellitus, Type 2, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Janagliflozin compared to placebo, both in combination with Metformin, in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with Metformin alone. 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?
- Janagliflozin plus metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2019to 31 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- T2DM Patients with inadequate glycemic control (HbA1c level≥7.0% and ≤10.5% at baseline) on metformin monotherapy.
- Body Mass Index: 18.0~35.0 kg/m2 (both inclusive)
Who cannot join
- History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
- More than 10% change in body weight within the 3 months before screening
- Any laboratory test indicators meet the following standards:
- fasting plasma glucose ≥ 15 mmol/L
- aspartate aminotransferase, alanine aminotransferase levels > 3 times the upper limit of normal (ULN); total bilirubin > 1.5 times ULN
- hemoglobin < 100 g/L
- eGFR < 60 mL/min/1.73m2
- fasting triglycerides > 5.64 mmol/L (500 mg/dL)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Linong Ji
Beijing, Beijing Municipality
Linong Ji, 00861088325578 ext. 00861088325578, plum_jj@sina.com
About this study
Official title: Efficacy and Safety of Janagliflozin in Combination With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control With Metformin Alone
The purpose of this study is to evaluate the efficacy and safety of Janagliflozin compared to placebo, both in combination with Metformin, in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with Metformin alone.
Read the detailed description
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study (a 24-week core period followed by a 28-week extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo, all in combination with Metformin, in patients diagnosed with T2DM who are not achieving an adequate response from Metformin monotherapy. Approximately 390 patients with inadequate glycemic control with Metformin monotherapy will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg , both in combination with Metformin , for 52 weeks, or receive 24 weeks of double-blind treatment with placebo in combination with Metformin followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg, both in combination with Metformin. During the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with Linagliptin (rescue therapy) consistent with local prescribing information.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Janagliflozin plus metformin, Placebo plus metformin
- 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.
Janagliflozin plus metforminDrug
Janagliflozin: Tablets, Oral, 25 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.
Janagliflozin plus metforminDrug
Janagliflozin: Tablets, Oral, 50 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.
Placebo plus metforminDevice
Placebo: Tablets, Oral, 25/50 mg, Once daily, 24 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Janagliflozin 25 mg plus metformin | Experimental | Each patient will receive 25 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period) Receives: Drug: Janagliflozin plus metformin |
| Janagliflozin 50 mg plus metformin | Experimental | Each patient will receive 50 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period) Receives: Drug: Janagliflozin plus metformin |
| Placebo/Janagliflozin plus metformin | Placebo comparator | In the core period, each patient will receive placebo plus metformin for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin plus metformin until Week 52. Receives: Device: Placebo plus metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 24 (Core period)
To examine whether the mean change in HbA1c from Baseline to Week 24 with Janagliflozin is superior to placebo
Measured: Baseline and Week 24
Secondary outcomes (12)
Change in HbA1c From Baseline to Week 52
To compare the mean change in HbA1c from Baseline to Week 52 between groups
Measured: Baseline and Week 52
Percentage of Patients With HbA1c <7% at Week 24 (Core period) and Week 52 (Extension period)
To compare the percentage of patients with HbA1c <7% at Week 24 (core period) and Week 52 (extension period) between groups
Measured: Week 24 and week 52
Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)
To compare the percentage of patients with HbA1c <6.5% at week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in fasting plasma glucose (FPG) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Change in 2-hour Post-prandial Glucose From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in 2-hour post-prandial glucose from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Change in Blood Lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in blood lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Change in Blood Pressure (systolic blood pressure and diastolic blood pressure) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in blood pressure (systolic blood pressure and diastolic blood pressure) from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Change in Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in body weight from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Change in Fasting C-peptide From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in fasting C-peptide from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period) by calculation Homeostasis model assessment-insulin resistance
To compare the mean change in insulin sensitivity from Baseline to Week 24 (core period) and Week 52 (extension period) between group by calculation Homeostasis model assessment-insulin resistance
Measured: Baseline, Week 24 and Week 52
Change in β-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)
To compare the mean change in β-cell function from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
Measured: Baseline, Week 24 and Week 52
Percentage of Patients Who Have Received Rescue Therapy at Week 24 (Core period) and Week 52 (Extension period)
To compare the percentage of patients who have received rescue therapy by Week 24 (core period) and Week 52 (extension period) between groups.
Measured: Baseline, Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start30 Jun 2019
- Primary completion30 Apr 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851432
- Sponsor's protocol ID
- 5695-DIA-3002
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Janagliflozin in Combination With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control With Metformin Alone
- ClinicalTrials.gov ID
- NCT03851432
- Acronym / sponsor ID
- 5695-DIA-3002
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Janagliflozin compared to placebo, both in combination with Metformin, in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with Metformin alone.
Detailed description
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study (a 24-week core period followed by a 28-week extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo, all in combination with Metformin, in patients diagnosed with T2DM who are not achieving an adequate response from Metformin monotherapy. Approximately 390 patients with inadequate glycemic control with Metformin monotherapy will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg , both in combination with Metformin , for 52 weeks, or receive 24 weeks of double-blind treatment with placebo in combination with Metformin followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg, both in combination with Metformin. During the treatment, if a patient's glycemic level remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with Linagliptin (rescue therapy) consistent with local prescribing information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Janagliflozin 25 mg plus metformin | Experimental | Drug: Janagliflozin plus metforminEach patient will receive 25 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period) |
| Janagliflozin 50 mg plus metformin | Experimental | Drug: Janagliflozin plus metforminEach patient will receive 50 mg of Janagliflozin plus metformin for 52 weeks (a 24-week core period followed by a 28-week extension period) |
| Placebo/Janagliflozin plus metformin | Placebo comparator | Device: Placebo plus metforminIn the core period, each patient will receive placebo plus metformin for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin plus metformin until Week 52. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- T2DM Patients with inadequate glycemic control (HbA1c level≥7.0% and ≤10.5% at baseline) on metformin monotherapy.
- Body Mass Index: 18.0~35.0 kg/m2 (both inclusive)
Key exclusion criteria (8 listed)
- History of type 1 diabetes mellitus (T1DM), diabetes caused by pancreatic injury, or secondary diabetes (e.g., diabetes caused by Cushing's syndrome or acromegaly)
- More than 10% change in body weight within the 3 months before screening
- Any laboratory test indicators meet the following standards:
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 |
|---|---|---|
| Janagliflozin plus metforminJanagliflozin: Tablets, Oral, 25 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study. | Drug | Janagliflozin 25 mg plus metformin |
| Janagliflozin plus metforminJanagliflozin: Tablets, Oral, 50 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study. | Drug | Janagliflozin 50 mg plus metformin |
| Placebo plus metforminPlacebo: Tablets, Oral, 25/50 mg, Once daily, 24 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study. | Device | Placebo/Janagliflozin plus metformin |
Primary outcome
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 24 (Core period)
Time frame: Baseline and Week 24
To examine whether the mean change in HbA1c from Baseline to Week 24 with Janagliflozin is superior to placebo
12 secondary outcomes
Change in HbA1c From Baseline to Week 52
Time frame: Baseline and Week 52
Percentage of Patients With HbA1c <7% at Week 24 (Core period) and Week 52 (Extension period)
Time frame: Week 24 and week 52
Percentage of Patients With HbA1c <6.5% at Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Change in 2-hour Post-prandial Glucose From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Change in Blood Lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Change in Blood Pressure (systolic blood pressure and diastolic blood pressure) From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Change in Body Weight From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Change in Fasting C-peptide From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Change in Insulin Sensitivity From Baseline to Week 24 (Core period) and Week 52 (Extension period) by calculation Homeostasis model assessment-insulin resistance
Time frame: Baseline, Week 24 and Week 52
Change in β-cell Function From Baseline to Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Percentage of Patients Who Have Received Rescue Therapy at Week 24 (Core period) and Week 52 (Extension period)
Time frame: Baseline, Week 24 and Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Janagliflozin plus metformin in people with Diabetes Mellitus, Type 2, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leili Gao, Doctor (00861088325578 ext. 00861088325578, plum_jj@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 24 (Core period) (time frame: Baseline and 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 16 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.