A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
- Registration Number
- NCT04663282
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INS068 INS068 injection Intervention: Drug: INS068 injection IDeg Insulin Degludec Intervention: Drug: insulin Degludec
- Primary Outcome Measures
Name Time Method Change in HbA1c Week 0 to Week 16 Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment
- Secondary Outcome Measures
Name Time Method 9-point SMPG profiles Week 0 to Week 16 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.
Changes in Body Mass Index Week 0 to Week 16 Change of Body Mass Index was evaluated from Week 0 to Week 16
Proportion of subjects reaching HbA1c targets Week 0 to Week 16 HbA1c \<7% or HbA1c ≤6.5%
Frequency and severity of adverse events Week 0 to Week 16 + 14 days follow-up 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.
Anti-drug Antibodies: Anti-INS068 Antibodies Week 0 to Week 16+14 days follow-up Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.
Changes in Body Weight Week 0 to Week 16 Change of body weight was evaluated from Week 0 to Week 16
Change in FPG Week 0 to Week 16 Change from baseline in FPG after 16 weeks of treatment
Titration target Week 0 to Week 16 Proportion of subjects and time reaching titration targets
Pre-breakfast SMPG Week 0 to Week 16 Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.
Change in Health Related Quality of Life Questionnaire (SF -36) Week 0 to Week 16 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)
Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication Week 0 to Week 16 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).
Numbers of injection site reactions Week 0 to Week 16 The injection site reactions was assessed during the treatment period of 16 weeks.
Serum INS068 concentration Week 0 to Week 16 To evaluate PK of INS068
Trial Locations
- Locations (35)
Torrance Clinical Research Institute Inc
🇺🇸Lomita, California, United States
Core Research Group Pty Ltd
🇦🇺Brisbane, Queensland, Australia
The Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Austin Health (Heidelberg Repatriation Hospital)
🇦🇺Melbourne, Victoria, Australia
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology
🇨🇳Wuhan, Hubei, China
Yibin Second People's Hospital
🇨🇳Yibin, Sichuan, China
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Shengjing Hospital Of China Medical University
🇨🇳Shenyang, Liaoning, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
Zhongda Hospital Affiliated to Southeast University
🇨🇳Nanjing, Jiangsu, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Shanghai Xuhui District Central Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
National Research Institute - Huntington Park
🇺🇸Huntington Park, California, United States
ALL Medical Research, LLC
🇺🇸Cooper City, Florida, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Shanghai Putuo District Central Hospital
🇨🇳Shanghai, Shanghai, China
Clinical Trials Research
🇺🇸Lincoln, California, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
National Research Institute - Wilshire
🇺🇸Los Angeles, California, United States
New Generation of Medical Research
🇺🇸Hialeah, Florida, United States
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States
Endocrinology Associates, Inc
🇺🇸Columbus, Ohio, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Juno Research, LL
🇺🇸Houston, Texas, United States
Juno Research, LLC - Medical Center Office
🇺🇸Houston, Texas, United States
Juno Research, LLC - Southwest Houston Site
🇺🇸Houston, Texas, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China