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

NCT04965051 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-16

No results posted yet for this study

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).

Conditions

  • Type 1 Diabetes Mellitus With Diabetic Gastroparesis
  • HbA1c
  • Time in Range

Interventions

DRUG

insulin degludec/insulin aspart (IDegAsp)

To evaluate the efficacy and safety of the IDegAsp in T1DM

DRUG

basal insulin plus pre-prandial insulin

To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yuezhong Ren, MD · 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965051 on ClinicalTrials.gov