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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04965051

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus With Diabetic Gastroparesis HbA1c Time in Range	Drug: insulin degludec/insulin aspart (IDegAsp) Drug: basal insulin plus pre-prandial insulin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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