A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics

Type 2 Diabetes Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663282
• Other study ID #: INS068-201
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 2021
• Est. completion date: May 28, 2022

Study information

• Verified date: January 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: May 28, 2022
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• INS068 injection
INS068 injected subcutaneously once daily. Treat-to-target dose titration during the trial
• Insulin Degludec
Insulin Degludec injected subcutaneously once daily. Treat-to-target dose titration during the trial

Locations

Country	Name	City	State
Australia	Core Research Group Pty Ltd	Brisbane	Queensland
Australia	Austin Health (Heidelberg Repatriation Hospital)	Melbourne	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria
China	Peking University People's Hospital	Beijing	Beijing
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chongqing University Three Gorges Hospital	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Hainan General Hospital	Haikou	Hainan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Zhongda Hospital Affiliated to Southeast University	Nanjing	Jiangsu
China	Shanghai Putuo District Central Hospital	Shanghai	Shanghai
China	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai
China	Shengjing Hospital Of China Medical University	Shenyang	Liaoning
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology	Wuhan	Hubei
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Yibin Second People's Hospital	Yibin	Sichuan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
United States	Endocrinology Associates, Inc	Columbus	Ohio
United States	ALL Medical Research, LLC	Cooper City	Florida
United States	Prestige Clinical Research	Franklin	Ohio
United States	New Generation of Medical Research	Hialeah	Florida
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	National Research Institute - Huntington Park	Huntington Park	California
United States	Clinical Trials Research	Lincoln	California
United States	Torrance Clinical Research Institute Inc	Lomita	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Clinical Pharmacology of Miami, LLC	Miami	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change from baseline in Glycosylated Haemoglobin after 16 weeks of treatment	Week 0 to Week 16
Secondary	Proportion of subjects reaching HbA1c targets	HbA1c <7% or HbA1c =6.5%	Week 0 to Week 16
Secondary	Change in FPG	Change from baseline in FPG after 16 weeks of treatment	Week 0 to Week 16
Secondary	9-point SMPG profiles	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.	Week 0 to Week 16
Secondary	Pre-breakfast SMPG	Mean plasma glucose, Within-subject variability of pre-breakfast SMPG.	Week 0 to Week 16
Secondary	Titration target	Proportion of subjects and time reaching titration targets	Week 0 to Week 16
Secondary	Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication	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).	Week 0 to Week 16
Secondary	Numbers of injection site reactions	The injection site reactions was assessed during the treatment period of 16 weeks.	Week 0 to Week 16
Secondary	Frequency and severity of adverse events	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.	Week 0 to Week 16 + 14 days follow-up
Secondary	Anti-drug Antibodies: Anti-INS068 Antibodies	Number of Participants Positive or Negative for Anti-INS068 Antibodies were reported.	Week 0 to Week 16+14 days follow-up
Secondary	Changes in Body Weight	Change of body weight was evaluated from Week 0 to Week 16	Week 0 to Week 16
Secondary	Changes in Body Mass Index	Change of Body Mass Index was evaluated from Week 0 to Week 16	Week 0 to Week 16
Secondary	Change in Health Related Quality of Life Questionnaire (SF -36)	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)	Week 0 to Week 16
Secondary	Serum INS068 concentration	To evaluate PK of INS068	Week 0 to Week 16