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

HbA1c Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965051
• Other study ID #: 2021-0407
• Status: Recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: December 2023

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuezhong Ren, MD
• Phone: +86 0571 87783516
• Email: renyuez[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Gastroparesis
• HbA1c
• Time in Range

Intervention

Drug:
• insulin degludec/insulin aspart (IDegAsp)
To evaluate the efficacy and safety of the IDegAsp in T1DM
• basal insulin plus pre-prandial insulin
To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	the change from baseline in HbA1c after 16 weeks of treatment in all patients	16 weeks
Secondary	Time In Range (TIR)	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
Secondary	Time to occurrence of treat to target	Fasting glucose on treatment <7mmol/L and non-fasting glucose <10mmol/L, or TIR >70%) (SMBG or FCGM)	16 weeks
Secondary	Occurrence of a treat to target response and without any hypoglycemic episodes	Occurrence of a treat to target response and without any hypoglycemic episodes	16 weeks
Secondary	EQ-5D Health Questionnaire	the EQ-5D descriptive system The change from baseline after 16 weeks of treatment	16 weeks
Secondary	Short Form 36 (SF-36)	The change from baseline after 16 weeks of treatment	16 weeks
Secondary	Insulin dose	The change from baseline after 16 weeks of treatment	16 weeks