Type 2 DiabetesPhase 3NCT05699408
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
A Phase 3 study testing INS068 injection and Insulin Glargine in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- INS068 injection and Insulin Glargine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2023to 23 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes ≥ 6 months；
- Stable daily dose(s) for ≥8 weeks prior to screening of any of the following anti-diabetic drug(s) or combination regimen(s): 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any of the following oral antidiabetic drugs with dose ≥half of the maximum approved dose according to local label or maximum tolerated): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones and Alpha-glucosidase inhibitors.
- Glycated hemoglobin was 7.0%~11.0% (both inclusive) at screening
Who cannot join
- Known or suspected allergy or intolerance to the investigational medicinal products or related products；
- Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；
- Potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；
- Have used insulin therapy anytime in the past 2 years, except for short-term insulin treatment and prior treatment for gestational diabetes.
- Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 1 month or 5 half-lives, whichever is longer, prior to screening;
- Women who are pregnant, breastfeeding or planning to conceive, or women of childbearing potential are reluctant to use appropriate contraception during the trial and for at least 14 days after the last dose of the investigational medicinal drug;
- Any conditions that the Investigator judges might not besuitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial Comparing the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
The study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- INS068 injection, Insulin Glargine
- 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.
INS068 injectionDrug
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Insulin GlargineDrug
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
| Study group | Role | What they receive |
|---|---|---|
| INS068 injection | Experimental | Not described Receives: Drug: INS068 injection |
| Insulin Glargine | Active comparator | Not described Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
Measured: Week 0 to Week 26
Secondary outcomes (14)
Change in FPG(fasting plasma glucose)
Change from baseline in FPG after 26 weeks and 52 weeks of treatment
Measured: Week 0 to Week 26, Week 0 to Week 52
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks and 52 weeks of treatment
Measured: Week 0 to Week 26 、Week 0 to Week 52
Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period
Measured: Week 0 to Week 26, Week 0 to Week 52
Change in HbA1c
Measured: Week 0 to Week 52
per-breakfast SMPG
Measured: Week 0 to Week 26 、Week 0 to Week 52
8-point SMPG profiles
Measured: Week 0 to Week 26 、Week 0 to Week 52
Average daily Insulin dose
Measured: Week 0 to Week 26 、Week 0 to Week 52
Proportion of Subjects requiring rescue therapy during treatment
Measured: Week 0 to Week 26 、Week 0 to Week 52
Frequency and severity of adverse events
Measured: Week 0 to Week 52 + 14 days follow-up
Incidence and rate of Hypoglycemic events
Measured: Week 0 to Week 52 + 14 days follow-up
Change in weight
Measured: Week 0 to Week 26、Week 0 to Week 52
Anti-drug Antibodies
Measured: Week 0 to Week 52 + 14 days follow-up
Serum INS068 concentration
Measured: Week 0 to Week 52
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Measured: Week 0 to Week 26 、Week 0 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start31 Mar 2023
- Primary completion23 Nov 2024
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Model description
- Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
- Masking
- None (open label)
- Enrolment
- 513 participants (actual)
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
- NCT05699408
- Sponsor's protocol ID
- INS068-302
- Status last verified
- Feb 2025
- First submitted
- 17 Jan 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial Comparing the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs
- ClinicalTrials.gov ID
- NCT05699408
- Acronym / sponsor ID
- INS068-302
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 26 Jan 2023 (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 study is being conducted to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with oral antidiabetic drugs compared to insulin Glargine QD for 26+26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
| Arm | Type | Receives |
|---|---|---|
| INS068 injection | Experimental | Drug: INS068 injection |
| Insulin Glargine | Active comparator | Drug: Insulin Glargine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes ≥ 6 months；
- Stable daily dose(s) for ≥8 weeks prior to screening of any of the following anti-diabetic drug(s) or combination regimen(s): 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any of the following oral antidiabetic drugs with dose ≥half of the maximum approved dose according to local label or maximum tolerated): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones and Alpha-glucosidase inhibitors.
- Glycated hemoglobin was 7.0%~11.0% (both inclusive) at screening
Key exclusion criteria (7 listed)
- Known or suspected allergy or intolerance to the investigational medicinal products or related products；
- Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；
- Potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；
- Have used insulin therapy anytime in the past 2 years, except for short-term insulin treatment and prior treatment for gestational diabetes.
- Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 1 month or 5 half-lives, whichever is longer, prior to screening;
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 |
|---|---|---|
| INS068 injectionINS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial | Drug | INS068 injection |
| Insulin GlargineInsulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial | Drug | Insulin Glargine |
Primary outcome
Change in HbA1c
Time frame: Week 0 to Week 26
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
14 secondary outcomes
Change in FPG(fasting plasma glucose)
Time frame: Week 0 to Week 26, Week 0 to Week 52
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Proportion of Subjects achieving HbA1c targets (HbA1c<7%; HbA1c≤6.5%) and without grade 2 or 3 hypoglycaemia in the last 12 weeks of the treatment period
Time frame: Week 0 to Week 26, Week 0 to Week 52
Change in HbA1c
Time frame: Week 0 to Week 52
per-breakfast SMPG
Time frame: Week 0 to Week 26 、Week 0 to Week 52
8-point SMPG profiles
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Average daily Insulin dose
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Proportion of Subjects requiring rescue therapy during treatment
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Frequency and severity of adverse events
Time frame: Week 0 to Week 52 + 14 days follow-up
Incidence and rate of Hypoglycemic events
Time frame: Week 0 to Week 52 + 14 days follow-up
Change in weight
Time frame: Week 0 to Week 26、Week 0 to Week 52
Anti-drug Antibodies
Time frame: Week 0 to Week 52 + 14 days follow-up
Serum INS068 concentration
Time frame: Week 0 to Week 52
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Time frame: Week 0 to Week 26 、Week 0 to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 INS068 injection and Insulin Glargine in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., 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 3 inclusion and 7 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 18 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in HbA1c (time frame: Week 0 to Week 26). 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 18 Feb 2025.