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

Hengrui Medicine

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Insulin Degludec

Drug: INS068 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT04663282

INS068-201

Details and patient eligibility

About

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.

Enrollment

179 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.