Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Insulin; Insulin Aspart; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Patients ≥ 18 and ≤75 years with type 1 diabetes;

• Diagnosed as T1DM ≥ 12 months before enrollment in the study;

• HbA1c ≥ 7.0 to ≤10.0%;

• Receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study;

• BMI ≤ 35kg / m2.

Exclusion Criteria:

• Patients with any of the following conditions will be excluded:

• Pregnant or lactating women

• Severe hypoglycemia within one month;

• Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent

• Receipt of Sulfonylureas, Meglitinides derivatives, Thiazolidinediones, Dpp-4 inhibitors or GLP-1 agonists within 3 months prior to informed consent;

• Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent

• Severe mental instability, or alcohol abuse, or drug abuse

• Cancer within 5 years prior to informed consent

• Pancreatitis of severe infectious diseases within 1 months prior to informed consent

• Known hypersensitivity or allergy to the insulin

• Renal impairment (CKD-EPI eGFR<60ml/min)

• Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined

• Participation in another trial within 2 months prior to informed consent

• Patients that investigators believe may fail to complete the study