Clinical trial NCT04663282: A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: INS068 campared with Insulin degludec, both in Combination with One or Two Oral Antidiabetics
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: Week 0 to Week 16
Secondary outcomes:
measure: Proportion of subjects reaching HbA1c targets
timeFrame: Week 0 to Week 16
measure: Change in FPG
timeFrame: Week 0 to Week 16
measure: 9-point SMPG profiles
timeFrame: Week 0 to Week 16
measure: Pre-breakfast SMPG
timeFrame: Week 0 to Week 16
measure: Titration target
timeFrame: Week 0 to Week 16
measure: Numbers of hypoglycaemic episodes according to 2017 ADA/EASD classfication
timeFrame: Week 0 to Week 16
measure: Numbers of injection site reactions
timeFrame: Week 0 to Week 16
measure: Frequency and severity of adverse events
timeFrame: Week 0 to Week 16 + 14 days follow-up
measure: Anti-drug Antibodies: Anti-INS068 Antibodies
timeFrame: Week 0 to Week 16+14 days follow-up
measure: Changes in Body Weight
timeFrame: Week 0 to Week 16
measure: Changes in Body Mass Index
timeFrame: Week 0 to Week 16
measure: Change in Health Related Quality of Life Questionnaire (SF -36)
timeFrame: Week 0 to Week 16
measure: Serum INS068 concentration
timeFrame: Week 0 to Week 16
Other outcomes:
Locations:
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: New Generation of Medical Research
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Columbus
country: United States
facility: Endocrinology Associates, Inc
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Houston
country: United States
facility: Juno Research, LL
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC - Medical Center Office
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC - Southwest Houston Site
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: Brisbane
country: Australia
facility: Core Research Group Pty Ltd
state: Queensland
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health (Heidelberg Repatriation Hospital)
state: Victoria
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Scince and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Affiliated to Southeast University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Xuhui District Central Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Putuo District Central Hospital
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
Study officials:
References: