Status:
COMPLETED
A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ins...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2022
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04663282
Start Date
February 4 2021
End Date
May 28 2022
Last Update
December 21 2022
Active Locations (35)
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1
National Research Institute - Huntington Park
Huntington Park, California, United States, 90255
2
Clinical Trials Research
Lincoln, California, United States, 95648
3
Torrance Clinical Research Institute Inc
Lomita, California, United States, 90717
4
National Research Institute - Wilshire
Los Angeles, California, United States, 90057