Diabetes Type 2Phase 3NCT03811548
Janagliflozin Treat T2DM Monotherapy
A Phase 3 study testing Janagliflozin 25mg and Janagliflozin 50mg in people with Diabetes Type 2, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Janagliflozin 25mg and Janagliflozin 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 442 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2019to 31 Dec 2020
- 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
- All patients must have a diagnosis of T2DM (meet the diagnostic criteria for diabetes issued by the World Health Organization in 1999)
- Patients must have a hemoglobin A1c (HbA1c) level ≥7.5% and ≤11% at screening, and ≥7.0% and ≤10.5% at baseline.
- Drug -naïve (never received anti-diabetic medication or did not receive anti-diabetic medication within 8 weeks before screening).
- 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: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled Study, to Evaluate the Efficacy and Safety of Janagliflozin (25 mg and 50 mg) as Monotherapy in Chinese Patients Diagnosed With T2DM
The purpose of this study is to assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics.
Read the detailed description
A multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 Weeks Extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg. 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 metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally once daily.
- Conditions
- Diabetes Type 2
- Being tested
- Janagliflozin 25mg, Janagliflozin 50mg, Placebo/Janagliflozin
- 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 25mgDrug
Also called Placebo 50mg
Tablets, Oral, 25 mg, Tablets, Oral, 50 mg
Janagliflozin 50mgDrug
Also called Placebo 25mg
Tablets, Oral, 25 mg, Once daily, 52 weeks
Placebo/JanagliflozinDrug
Tablets, Oral, 25 mg, Once daily, 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Janagliflozin 25mg | Experimental | Each patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period) Receives: Drug: Janagliflozin 25mg |
| Janagliflozin 50mg | Experimental | Each patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period) Receives: Drug: Janagliflozin 50mg |
| Placebo/Janagliflozin | Experimental | In the core period, each patient will receive placebo once daily for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin once daily until Week 52. Receives: Drug: Placebo/Janagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Baseline to Week 24
To examine whether the mean change in HbA1c from baseline to week 24 with Janagliflozin is superiority (superiority margin of 0.5%) 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
To compare the percentage of patients with HbA1c <7% at week 24 (core period) and week 52 (extension period) between groups
Measured: Baseline, 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)
To compare the mean change in insulin sensitivity from Baseline to Week 24 (core period) and Week 52 (extension period) between groups
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: 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 Jan 2019
- Study start23 May 2019
- Primary completion24 Jun 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes 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
- 442 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
- NCT03811548
- Sponsor's protocol ID
- 5695-DIA-3001
- Status last verified
- Jul 2020
- First submitted
- 17 Jan 2019
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled Study, to Evaluate the Efficacy and Safety of Janagliflozin (25 mg and 50 mg) as Monotherapy in Chinese Patients Diagnosed With T2DM
- ClinicalTrials.gov ID
- NCT03811548
- Acronym / sponsor ID
- 5695-DIA-3001
- Conditions
- Diabetes Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Jan 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 assess the effect of Janagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 24 weeks of treatment, and to assess the efficacy after 52 weeks of treatment, overall safety and Population pharmacokinetics.
Detailed description
A multicentre, randomized, double-blind, parallel group, placebo-controlled study(24 weeks core period followed by 28 Weeks Extension period), to evaluate the efficacy and safety of Janagliflozin (25 mg and 50 mg) compared to placebo in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 390 patients with inadequate glycemic control with diet and exercise will receive once-daily double-blind treatment with Janagliflozin 25 mg or 50 mg once daily for 52 weeks, or 24 weeks of double-blind treatment with placebo followed by 28 weeks of single-blind treatment with Janagliflozin 25 mg or 50 mg. 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 metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally once daily.
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 25mg | Experimental | Drug: Janagliflozin 25mgEach patient will receive 25 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period) |
| Janagliflozin 50mg | Experimental | Drug: Janagliflozin 50mgEach patient will receive 50 mg of Janagliflozin once daily for 52 weeks (24 weeks core period followed by 28 Weeks Extension period) |
| Placebo/Janagliflozin | Experimental | Drug: Placebo/JanagliflozinIn the core period, each patient will receive placebo once daily for 24 weeks and will then switch from placebo to 25 mg or 50 mg of Janagliflozin once daily 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 (4 listed)
- All patients must have a diagnosis of T2DM (meet the diagnostic criteria for diabetes issued by the World Health Organization in 1999)
- Patients must have a hemoglobin A1c (HbA1c) level ≥7.5% and ≤11% at screening, and ≥7.0% and ≤10.5% at baseline.
- Drug -naïve (never received anti-diabetic medication or did not receive anti-diabetic medication within 8 weeks before screening).
- 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 25mgAlso: Placebo 50mgTablets, Oral, 25 mg, Tablets, Oral, 50 mg | Drug | Janagliflozin 25mg |
| Janagliflozin 50mgAlso: Placebo 25mgTablets, Oral, 25 mg, Once daily, 52 weeks | Drug | Janagliflozin 50mg |
| Placebo/JanagliflozinTablets, Oral, 25 mg, Once daily, 52 weeks | Drug | Placebo/Janagliflozin |
Primary outcome
Change in HbA1c From Baseline to Week 24
Time frame: Baseline and Week 24
To examine whether the mean change in HbA1c from baseline to week 24 with Janagliflozin is superiority (superiority margin of 0.5%) 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
Time frame: Baseline, 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)
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: 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.
- Individual participant dataSharing planned: Undecided
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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 25mg and Janagliflozin 50mg in people with Diabetes 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 4 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. 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. 00861088324516, 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 HbA1c From Baseline to Week 24 (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.