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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

Primary Purpose

Type 2 Diabetes

Status
Enrolling by invitation
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
INS068 injection
Insulin Glargine
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

INS068 injection

Insulin Glargine

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment

Secondary Outcome Measures

Change in FPG(fasting plasma glucose)
Change from baseline in FPG after 26 weeks and 52 weeks of treatment
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
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
Change in HbA1c
per-breakfast SMPG
8-point SMPG profiles
Average daily Insulin dose
Proportion of Subjects requiring rescue therapy during treatment
Frequency and severity of adverse events
Incidence and rate of Hypoglycemic events
Change in weight
Anti-drug Antibodies
Serum INS068 concentration
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)

Full Information

First Posted
January 17, 2023
Last Updated
April 18, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05699408
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
September 23, 2025 (Anticipated)
Study Completion Date
September 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Open-Label, Controlled, Parallel-group, Multicenter Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
501 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INS068 injection
Arm Type
Experimental
Arm Title
Insulin Glargine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
INS068 injection
Intervention Description
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
Insulin Glargine injected subcutaneously once daily. Treat-to-target dose titration during the trial
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change from baseline in Glycosylated Haemoglobin after 26 weeks of treatment
Time Frame
Week 0 to Week 26
Secondary Outcome Measure Information:
Title
Change in FPG(fasting plasma glucose)
Description
Change from baseline in FPG after 26 weeks and 52 weeks of treatment
Time Frame
Week 0 to Week 26, Week 0 to Week 52
Title
Proportion of Subjects with HbA1c<7% and HbA1c≤6.5%
Description
Proportion of subjects with HbA1c<7% and HbA1c≤6.5% after 26 weeks and 52 weeks of treatment
Time Frame
Week 0 to Week 26 、Week 0 to Week 52
Title
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
Title
Change in HbA1c
Time Frame
Week 0 to Week 52
Title
per-breakfast SMPG
Time Frame
Week 0 to Week 26 、Week 0 to Week 52
Title
8-point SMPG profiles
Time Frame
Week 0 to Week 26 、Week 0 to Week 52
Title
Average daily Insulin dose
Time Frame
Week 0 to Week 26 、Week 0 to Week 52
Title
Proportion of Subjects requiring rescue therapy during treatment
Time Frame
Week 0 to Week 26 、Week 0 to Week 52
Title
Frequency and severity of adverse events
Time Frame
Week 0 to Week 52 + 14 days follow-up
Title
Incidence and rate of Hypoglycemic events
Time Frame
Week 0 to Week 52 + 14 days follow-up
Title
Change in weight
Time Frame
Week 0 to Week 26、Week 0 to Week 52
Title
Anti-drug Antibodies
Time Frame
Week 0 to Week 52 + 14 days follow-up
Title
Serum INS068 concentration
Time Frame
Week 0 to Week 52
Title
Change in scores of diabetes treatment satisfaction questionnaire status version (DTSQs)
Time Frame
Week 0 to Week 26 、Week 0 to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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