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

July 7, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Prospective, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With Type 1 Diabetes Mellitus

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDegAsp group
IDegAsp twice daily
Drug: insulin degludec/insulin aspart (IDegAsp)
To evaluate the efficacy and safety of the IDegAsp in T1DM
Other Names:
  • Ryzodeg
Active Comparator: basal insulin plus pre-prandial insulin group
basal insulin once or twice daily plus pre-prandial insulin
Drug: basal insulin plus pre-prandial insulin
To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM
Other Names:
  • Levemir/Lantus/Tresiba plus NovoLog/Humalog/Apidra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 16 weeks
the change from baseline in HbA1c after 16 weeks of treatment in all patients
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time In Range (TIR)
Time Frame: 16 weeks
The change from baseline in Time in Range (3.9-10mmol/L) after 16 weeks of treatment in all patients (using flash continuous glucose monitoring (FCGM)).
16 weeks
Time to occurrence of treat to target
Time Frame: 16 weeks
Fasting glucose on treatment <7mmol/L and non-fasting glucose <10mmol/L, or TIR >70%) (SMBG or FCGM)
16 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Time Frame: 16 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
16 weeks
EQ-5D Health Questionnaire
Time Frame: 16 weeks
the EQ-5D descriptive system The change from baseline after 16 weeks of treatment
16 weeks
Short Form 36 (SF-36)
Time Frame: 16 weeks
The change from baseline after 16 weeks of treatment
16 weeks
Insulin dose
Time Frame: 16 weeks
The change from baseline after 16 weeks of treatment
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Yuezhong Ren, MD, 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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