Type 2 Diabetes MellitusPhase 3NCT05702073
To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
A Phase 3 study testing INS068 injection and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 423 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2023to 11 Jun 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;
- HbA1c 7.0% ~ 10.0% (Both inclusive) at screening;
- Treated with Basal insulin ≥10U /day for at least 8 weeks prior to screening.
Who cannot join
- Known or suspected allergy or intolerance to investigational medicinal products or related products.
- Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- Potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
- Received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening.
- Participated in clinical trials of any approved or unapproved investigational drug/treatment within the previous 1 month or 5 half-life period, 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; Anycircumstances that the investigator judges might not be suitable to participate in the trial..
Trial locations and contacts
1 site in 1 country.
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 Basal Insulin
The study aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks.
- Conditions
- Type 2 Diabetes Mellitus
- 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 | Experimental | Not described Receives: Drug: INS068 injection |
| IGlar | 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 (12)
Change in FPG(fasting plasma glucose)
Change from baseline in FPG after 26 weeks of treatment
Measured: Week 0 to Week 26
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks of treatment
Measured: Week 0 to Week 26
per-breakfast SMPG
Mean and Within-subject variability of pre-breakfast SMPG after 26 weeks of treatment
Measured: Week 0 to Week 26
8-point SMPG profiles
Measured: Week 0 to Week 26
Average daily Insulin dose
Average daily Insulin dose after 26 weeks of treatment.
Measured: Week 0 to Week 26
Proportion of Subjects requiring rescue therapy during treatment
Proportion of subejcts requiring rescue therapy during 26 weeks of treatment
Measured: Week 0 to Week 26
Frequency and severity of adverse events
Severity (mild, moderate and severe) is assessed by investigator.
Measured: Week 0 to Week26 +14 days follow-up
Incidence and rate of Hypoglycemic events
Incidence and rate of of Hypoglycemic events
Measured: Week 0 to Week 26+14 days follow-up
Change in weight
Change from baseline in weight after 26weeks of treatment
Measured: Week 0 to Week 26
Anti-drug Antibodies
Number of subjects with Positive Anti-drug Antibodies
Measured: Week 0 to Week26 + 14 days follow-up
Serum INS068 concentration
To evaluate PK of INS068
Measured: Week 0 to Week 26
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Change from baseline in scores of DTSQs after 26 weeks of treatment.
Measured: Week 0 to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start31 Mar 2023
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 423 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
- NCT05702073
- Sponsor's protocol ID
- INS068-301
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2023
- Last updated
- 13 Mar 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 13 Mar 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 Basal Insulin
- ClinicalTrials.gov ID
- NCT05702073
- Acronym / sponsor ID
- INS068-301
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 27 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 aims to evaluate the efficacy and safety of INS068 once daily (QD) in subjects with type 2 diabetes not adequately controlled with basal insulin compared to insulin Glargine QD for 26weeks.
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 | Experimental | Drug: INS068 injection |
| IGlar | 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;
- HbA1c 7.0% ~ 10.0% (Both inclusive) at screening;
- Treated with Basal insulin ≥10U /day for at least 8 weeks prior to screening.
Key exclusion criteria (6 listed)
- Known or suspected allergy or intolerance to investigational medicinal products or related products.
- Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
- Potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
- Received premixed insulin, mealtime insulin, or insulin pump therapy within 8 weeks prior to screening.
- Participated in clinical trials of any approved or unapproved investigational drug/treatment within the previous 1 month or 5 half-life period, 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 |
| Insulin GlargineInsulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial | Drug | IGlar |
Primary outcome
Change in HbA1c
Time frame: Week 0 to Week 26
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
12 secondary outcomes
Change in FPG(fasting plasma glucose)
Time frame: Week 0 to Week 26
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Time frame: Week 0 to Week 26
per-breakfast SMPG
Time frame: Week 0 to Week 26
8-point SMPG profiles
Time frame: Week 0 to Week 26
Average daily Insulin dose
Time frame: Week 0 to Week 26
Proportion of Subjects requiring rescue therapy during treatment
Time frame: Week 0 to Week 26
Frequency and severity of adverse events
Time frame: Week 0 to Week26 +14 days follow-up
Incidence and rate of Hypoglycemic events
Time frame: Week 0 to Week 26+14 days follow-up
Change in weight
Time frame: Week 0 to Week 26
Anti-drug Antibodies
Time frame: Week 0 to Week26 + 14 days follow-up
Serum INS068 concentration
Time frame: Week 0 to Week 26
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Time frame: Week 0 to Week 26
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 13 Mar 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 Mellitus, 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 6 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 13 Mar 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 13 Mar 2025.