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

NCT04965051 | Unknown

• 1 other identifier: 2021-0407
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Type 1 Diabetes; insulin degludec/insulin aspart; HbA1c; Time in Range

Outcome Measures

Primary Outcomes (1)

• HbA1c

  the change from baseline in HbA1c after 16 weeks of treatment in all patients

  16 weeks

Secondary Outcomes (6)

• Time In Range (TIR)

  16 weeks

• Time to occurrence of treat to target

  16 weeks

• Occurrence of a treat to target response and without any hypoglycemic episodes

  16 weeks

• EQ-5D Health Questionnaire

  16 weeks

• Short Form 36 (SF-36)

  16 weeks

Study Arms (2)

IDegAsp group

EXPERIMENTAL

IDegAsp twice daily

Drug: insulin degludec/insulin aspart (IDegAsp)

basal insulin plus pre-prandial insulin group

ACTIVE COMPARATOR

basal insulin once or twice daily plus pre-prandial insulin

Drug: basal insulin plus pre-prandial insulin

Interventions

insulin degludec/insulin aspart (IDegAsp) DRUG

To evaluate the efficacy and safety of the IDegAsp in T1DM

Also known as: Ryzodeg

IDegAsp group

basal insulin plus pre-prandial insulin DRUG

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

Also known as: Levemir/Lantus/Tresiba plus NovoLog/Humalog/Apidra

basal insulin plus pre-prandial insulin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Aspart; insulin degludec, insulin aspart drug combination; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Yuezhong Ren, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuezhong Ren, MD

CONTACT

+86 0571 87783516; renyuez@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)