Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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)
Query!
Secondary ID [1]
0
0
INS068-201
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in HbA1c
Query!
Assessment method [1]
0
0
Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
Query!
Timepoint [1]
0
0
Week 0 to Week 16
Query!
Secondary outcome [1]
0
0
Proportion of subjects reaching HbA1c targets
Query!
Assessment method [1]
0
0
HbA1c \<7% or HbA1c =6.5%
Query!
Timepoint [1]
0
0
Week 0 to Week 16
Query!
Secondary outcome [2]
0
0
Change in FPG
Query!
Assessment method [2]
0
0
Change from baseline in FPG after 16 weeks of treatment
Query!
Timepoint [2]
0
0
Week 0 to Week 16
Query!
Secondary outcome [3]
0
0
9-point SMPG profiles
Query!
Assessment method [3]
0
0
Mean plasma glucose, Postprandial and nocturnal increments, Fluctuation of 9-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
Query!
Timepoint [3]
0
0
Week 0 to Week 16
Query!
Secondary outcome [4]
0
0
Pre-breakfast SMPG
Query!
Assessment method [4]
0
0
Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.
Query!
Timepoint [4]
0
0
Week 0 to Week 16
Query!
Secondary outcome [5]
0
0
Titration target
Query!
Assessment method [5]
0
0
Proportion of subjects and time reaching titration targets
Query!
Timepoint [5]
0
0
Week 0 to Week 16
Query!
Secondary outcome [6]
0
0
Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication
Query!
Assessment method [6]
0
0
Classification of hypoglycaemia: Level 1(glucose level below 3.9 mmol/L), Level 2(glucose level below 3.0 mmol/L) and Level 3(Severe hypoglycemia, denotes severe cognitive impairment requiring external assistance for recovery).
Query!
Timepoint [6]
0
0
Week 0 to Week 16
Query!
Secondary outcome [7]
0
0
Numbers of injection site reactions
Query!
Assessment method [7]
0
0
The injection site reactions was assessed during the treatment period of 16 weeks.
Query!
Timepoint [7]
0
0
Week 0 to Week 16
Query!
Secondary outcome [8]
0
0
Frequency and severity of adverse events
Query!
Assessment method [8]
0
0
Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities, no or minimal medical treatment. Moderate: marked symptoms, interference with subject's daily activities,and medical treatment for alleviation without grave or permanent injury to the subject. . Severe: considerable interference with subject's daily activities, and intensive treatment and intervention needed.
Query!
Timepoint [8]
0
0
Week 0 to Week 16 + 14 days follow-up
Query!
Secondary outcome [9]
0
0
Anti-drug Antibodies: Anti-INS068 Antibodies
Query!
Assessment method [9]
0
0
Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.
Query!
Timepoint [9]
0
0
Week 0 to Week 16+14 days follow-up
Query!
Secondary outcome [10]
0
0
Changes in Body Weight
Query!
Assessment method [10]
0
0
Change of body weight was evaluated from Week 0 to Week 16
Query!
Timepoint [10]
0
0
Week 0 to Week 16
Query!
Secondary outcome [11]
0
0
Changes in Body Mass Index
Query!
Assessment method [11]
0
0
Change of Body Mass Index was evaluated from Week 0 to Week 16
Query!
Timepoint [11]
0
0
Week 0 to Week 16
Query!
Secondary outcome [12]
0
0
Change in Health Related Quality of Life Questionnaire (SF -36)
Query!
Assessment method [12]
0
0
Change from baseline in scores of Health-Related Quality of Life Questionnaire after 16 weeks of treatment. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score)
Query!
Timepoint [12]
0
0
Week 0 to Week 16
Query!
Secondary outcome [13]
0
0
Serum INS068 concentration
Query!
Assessment method [13]
0
0
To evaluate PK of INS068
Query!
Timepoint [13]
0
0
Week 0 to Week 16
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/02/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/05/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
179
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
Core Research Group Pty Ltd - Brisbane
Query!
Recruitment hospital [2]
0
0
The Royal Melbourne Hospital - Melbourne
Query!
Recruitment hospital [3]
0
0
Austin Health (Heidelberg Repatriation Hospital) - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
4064 - Brisbane
Query!
Recruitment postcode(s) [2]
0
0
3050 - Melbourne
Query!
Recruitment postcode(s) [3]
0
0
3081 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Iowa
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Ohio
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Texas
Query!
Country [6]
0
0
China
Query!
State/province [6]
0
0
Beijing
Query!
Country [7]
0
0
China
Query!
State/province [7]
0
0
Chongqing
Query!
Country [8]
0
0
China
Query!
State/province [8]
0
0
Hainan
Query!
Country [9]
0
0
China
Query!
State/province [9]
0
0
Hebei
Query!
Country [10]
0
0
China
Query!
State/province [10]
0
0
Henan
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Hubei
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Jiangsu
Query!
Country [13]
0
0
China
Query!
State/province [13]
0
0
Jiangxi
Query!
Country [14]
0
0
China
Query!
State/province [14]
0
0
Liaoning
Query!
Country [15]
0
0
China
Query!
State/province [15]
0
0
Shaanxi
Query!
Country [16]
0
0
China
Query!
State/province [16]
0
0
Shanghai
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Shanxi
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Sichuan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Jiangsu HengRui Medicine Co., Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04663282
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04663282
Download to PDF