Diabetes Mellitus, Type IIPhase 3NCT04667143
Dual Add-on Therapy in Type 2 Diabetes Poorly Controlled With Metformin Monotherapy
A Phase 3 study testing Retagliptin, Henagliflozein, metformin XR in people with Diabetes Mellitus, Type II, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein added to Metformin compared to Retagliptin or Henagliflozein in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Retagliptin, Henagliflozein, metformin XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Oct 2022
- 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
- Men and women, 18-75 years old (both inclusive) at time of screening visit;
- Subjects with T2DM with inadequate glycemic control defined as central laboratory HbA1c ≥ 7.5 and ≤ 10.5 % at the screening visit;
- FPG ≤ 15mmol/L at the screening visit;
- Stable metformin therapy for at least 8 weeks prior to screening at a dose ≥ 1500 mg per day;
- 19.0<BMI ≤ 40.0 kg/m2 at the screening visit;
Who cannot join
- Moderate or severe impairment of renal function [defined as eGFR<60mL/min/1.73 m2 (estimated by MDRD);
- Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg;
- Cardiovascular diseases within 6 months of the screening visit;
- ALT and/or AST > 1.5 x ULN and or Total Bilirubin > 1.2 x ULN;
- Hemoglobin ≤ 100 g/L;
- CK (creatine kinase) and CK-MB > 3 x ULN;
- Malignancy within 5 years of the screening visit (with the exception of treated basal cell or treated squamous cell carcinoma);
- Administration of any antihyperglycemic therapy, other than metformin,within 2 months prior to screening;
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein Added to Metformin Compared to Retagliptin or Henagliflozein in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein added to Metformin compared to Retagliptin or Henagliflozein in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Retagliptin, Henagliflozein, metformin XR
- 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.
Retagliptin, Henagliflozein, metformin XRDrug
Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR
| Study group | Role | What they receive |
|---|---|---|
| Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR | Experimental | Not described Receives: Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR | Experimental | Not described Receives: Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR | Experimental | Not described Receives: Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR | Experimental | Not described Receives: Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR | Experimental | Not described Receives: Drug: Retagliptin, Henagliflozein, metformin XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in HbA1c at Week 24
- To compare the mean change from baseline in HbA1c achieved with concurrent addition of Retagliptin Plus Henagliflozein to metformin vs the addition of Retagliptin or Henagliflozein to metformin after 24 weeks of double-blind treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionOct 2022 (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 IIStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667143
- Sponsor's protocol ID
- SHR3824-SP2086-MET-301
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein Added to Metformin Compared to Retagliptin or Henagliflozein in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
- ClinicalTrials.gov ID
- NCT04667143
- Acronym / sponsor ID
- SHR3824-SP2086-MET-301
- Conditions
- Diabetes Mellitus, Type II
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 14 Dec 2020 (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.
2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein added to Metformin compared to Retagliptin or Henagliflozein in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR | Experimental | Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR | Experimental | Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR | Experimental | Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR | Experimental | Drug: Retagliptin, Henagliflozein, metformin XR |
| Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR | Experimental | Drug: Retagliptin, Henagliflozein, metformin XR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, 18-75 years old (both inclusive) at time of screening visit;
- Subjects with T2DM with inadequate glycemic control defined as central laboratory HbA1c ≥ 7.5 and ≤ 10.5 % at the screening visit;
- FPG ≤ 15mmol/L at the screening visit;
- Stable metformin therapy for at least 8 weeks prior to screening at a dose ≥ 1500 mg per day;
- 19.0<BMI ≤ 40.0 kg/m2 at the screening visit;
Key exclusion criteria (8 listed)
- Moderate or severe impairment of renal function [defined as eGFR<60mL/min/1.73 m2 (estimated by MDRD);
- Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg;
- Cardiovascular diseases within 6 months of the screening visit;
- ALT and/or AST > 1.5 x ULN and or Total Bilirubin > 1.2 x ULN;
- Hemoglobin ≤ 100 g/L;
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 |
|---|---|---|
| Retagliptin, Henagliflozein, metformin XRRetagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR | Drug | Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR, Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR, Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR, Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR, Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR |
Primary outcome
Mean change from baseline in HbA1c at Week 24
Time frame: 24 weeks
• To compare the mean change from baseline in HbA1c achieved with concurrent addition of Retagliptin Plus Henagliflozein to metformin vs the addition of Retagliptin or Henagliflozein to metformin after 24 weeks of double-blind treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Retagliptin, Henagliflozein, metformin XR in people with Diabetes Mellitus, Type II, run by Jiangsu HengRui Medicine Co., Ltd..
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 5 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 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Mean change from baseline in HbA1c at Week 24 (time frame: 24 weeks). 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 14 Dec 2020.