A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
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)
1 other identifier
interventional
179
3 countries
35
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes
Started Feb 2021
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2022
CompletedDecember 21, 2022
January 1, 2022
1.3 years
December 2, 2020
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
Week 0 to Week 16
Secondary Outcomes (13)
Proportion of subjects reaching HbA1c targets
Week 0 to Week 16
Change in FPG
Week 0 to Week 16
9-point SMPG profiles
Week 0 to Week 16
Pre-breakfast SMPG
Week 0 to Week 16
Titration target
Week 0 to Week 16
- +8 more secondary outcomes
Study Arms (2)
INS068
EXPERIMENTALIntervention: Drug: INS068 injection
IDeg
ACTIVE COMPARATORIntervention: Drug: insulin Degludec
Interventions
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
- Systemic or intra-articular corticosteroids treatment within the last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
National Research Institute - Huntington Park
Huntington Park, California, 90255, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Torrance Clinical Research Institute Inc
Lomita, California, 90717, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
New Generation of Medical Research
Hialeah, Florida, 33016, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014-3616, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Endocrinology Associates, Inc
Columbus, Ohio, 43201, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Juno Research, LL
Houston, Texas, 77040, United States
Juno Research, LLC - Medical Center Office
Houston, Texas, 77054, United States
Juno Research, LLC - Southwest Houston Site
Houston, Texas, 77074, United States
Endeavor Clinical Trials
San Antonio, Texas, 78229, United States
Core Research Group Pty Ltd
Brisbane, Queensland, 4064, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Austin Health (Heidelberg Repatriation Hospital)
Melbourne, Victoria, 3081, Australia
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404100, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology
Wuhan, Hubei, 430030, China
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, 210009, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110004, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200031, China
Shanghai Putuo District Central Hospital
Shanghai, Shanghai Municipality, 200062, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital,Sichuan University
Chengdu, Sichuan, 610000, China
Yibin Second People's Hospital
Yibin, Sichuan, 644000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2020
First Posted
December 10, 2020
Study Start
February 4, 2021
Primary Completion
May 28, 2022
Study Completion
May 28, 2022
Last Updated
December 21, 2022
Record last verified: 2022-01