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A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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)

NCT04663282•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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)
•Systemic or intra-articular corticosteroids treatment within the last 3 months.

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.

Locations (35)

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

ALL Medical Research, LLC

Cooper City, Florida, United States

New Generation of Medical Research

Hialeah, Florida, United States

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Endocrinology Associates, Inc

Columbus, Ohio, United States

Key Dates

Start Date

February 4, 2021

Primary Completion Date

May 28, 2022

Completion Date

May 28, 2022

Last Updated

December 21, 2022

Enrollment

179

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

INS068 injection

DRUG

Insulin Degludec

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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