Overview

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