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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04663282




Registration number
NCT04663282
Ethics application status
Date submitted
2/12/2020
Date registered
10/12/2020
Date last updated
21/12/2022

Titles & IDs
Public title
A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
Scientific title
Evaluation of the Efficacy and Safety of INS068 Injection and Insulin Degludec Subcutaneous Injection Once Daily in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With One or Two Oral Antidiabetics (A Randomized, Open-Label, Two-Arm, Treat-to-Target, Parallel Controlled Trial)
Secondary ID [1] 0 0
INS068-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INS068 injection
Treatment: Drugs - Insulin Degludec

Experimental: INS068 - Intervention: Drug: INS068 injection

Active Comparator: IDeg - Intervention: Drug: insulin Degludec


Treatment: Drugs: INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial

Treatment: Drugs: Insulin Degludec
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in HbA1c
Timepoint [1] 0 0
Week 0 to Week 16
Secondary outcome [1] 0 0
Proportion of subjects reaching HbA1c targets
Timepoint [1] 0 0
Week 0 to Week 16
Secondary outcome [2] 0 0
Change in FPG
Timepoint [2] 0 0
Week 0 to Week 16
Secondary outcome [3] 0 0
9-point SMPG profiles
Timepoint [3] 0 0
Week 0 to Week 16
Secondary outcome [4] 0 0
Pre-breakfast SMPG
Timepoint [4] 0 0
Week 0 to Week 16
Secondary outcome [5] 0 0
Titration target
Timepoint [5] 0 0
Week 0 to Week 16
Secondary outcome [6] 0 0
Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication
Timepoint [6] 0 0
Week 0 to Week 16
Secondary outcome [7] 0 0
Numbers of injection site reactions
Timepoint [7] 0 0
Week 0 to Week 16
Secondary outcome [8] 0 0
Frequency and severity of adverse events
Timepoint [8] 0 0
Week 0 to Week 16 + 14 days follow-up
Secondary outcome [9] 0 0
Anti-drug Antibodies: Anti-INS068 Antibodies
Timepoint [9] 0 0
Week 0 to Week 16+14 days follow-up
Secondary outcome [10] 0 0
Changes in Body Weight
Timepoint [10] 0 0
Week 0 to Week 16
Secondary outcome [11] 0 0
Changes in Body Mass Index
Timepoint [11] 0 0
Week 0 to Week 16
Secondary outcome [12] 0 0
Change in Health Related Quality of Life Questionnaire (SF -36)
Timepoint [12] 0 0
Week 0 to Week 16
Secondary outcome [13] 0 0
Serum INS068 concentration
Timepoint [13] 0 0
Week 0 to Week 16

Eligibility
Key inclusion criteria
- Informed consent obtained before any trial-related activities. (Trial-related
activities are any procedure that will not have been performed during normal
management of the subject.)

- Age is 18-75 years

- Diagnosed with Type 2 diabetes (according to the diagnosis criteria applicable
locally) for at least 3 months

- Treatment with one or two oral anti-diabetic drug (OADs): metformin at astable daily
dose of = 1500 mg or maximum tolerated dose (at least 1000mg daily), with or without
insulin secretagogue (SU or glinides) or DPP-4 inhibitors or SGLT-2 inhibitors or
alpha-glucosidase inhibitors for at least 8 weeks at a stable dose. The dose(s) of OAD
other than metformin should be minimum half of the daily maximal dose according to
local labelling or maximum tolerated dose.

- Insulin naïve. short-term insulin treatment (consecutive or cumulative treatment of
=14 days) and insulin treatment for gestational diabetes are allowed.

- HbA1c 7.0-10.0 % (53-85 mmol/mol) (both inclusive)

- BMI 19-40 kg/m2 (both inclusive)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known or suspected allergy or intolerance to the active substance or to any of the
excipients of the investigational medical products

- Severe hypoglycemia during the previous 6 months.

- Hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
during the previous 6 months.

- Cardiovascular disease within the last 12 months, defined as: stroke, decompensated
heart failure (New York Heart Association [NYHA] class III or IV), myocardial
infarction, or hospitalization for unstable angina pectoris or transient ischemic
attack.

- Diagnosis of malignant neoplasms (except basal cell or squamous cell skin cancer,
polyps and in-situ carcinomas) within the last 5 years or increased risk of cancer or
relapse of cancer.

- Any antidiabetic medication other than permitted in the inclusion criteria or any
weight-loss drug within the last 8 weeks..

- Systemic or intra-articular corticosteroids treatment within the last 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/05/2022
Sample size
Target
Accrual to date
Final
179
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Core Research Group Pty Ltd - Brisbane
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [3] 0 0
Austin Health (Heidelberg Repatriation Hospital) - Melbourne
Recruitment postcode(s) [1] 0 0
4064 - Brisbane
Recruitment postcode(s) [2] 0 0
3050 - Melbourne
Recruitment postcode(s) [3] 0 0
3081 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Chongqing
Country [8] 0 0
China
State/province [8] 0 0
Hainan
Country [9] 0 0
China
State/province [9] 0 0
Hebei
Country [10] 0 0
China
State/province [10] 0 0
Henan
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Jiangsu
Country [13] 0 0
China
State/province [13] 0 0
Jiangxi
Country [14] 0 0
China
State/province [14] 0 0
Liaoning
Country [15] 0 0
China
State/province [15] 0 0
Shaanxi
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Shanxi
Country [18] 0 0
China
State/province [18] 0 0
Sichuan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Jiangsu HengRui Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is being conducted to evaluate the efficacy and safety of IND068 once daily (QD) in
subjects with type 2 diabetes not adequately controlled with one or two oral antidiabetics
compared to insulin degludec QD for 16 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04663282
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries