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

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    40
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 23 July 2021

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).

Description

The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 40 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group. Duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.

Details
Condition Glycosylated hemoglobin, glycosylated haemoglobin, hba1c, hemoglobin a1c, Time in Range, Type 1 Diabetes Mellitus With Diabetic Gastroparesis
Treatment insulin degludec/insulin aspart (IDegAsp), basal insulin plus pre-prandial insulin
Clinical Study IdentifierNCT04965051
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

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
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