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

Primary Purpose

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

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

insulin degludec/insulin aspart (IDegAsp)

basal insulin plus pre-prandial insulin

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus With Diabetic Gastroparesis focused on measuring Type 1 Diabetes, insulin degludec/insulin aspart, HbA1c, Time in Range

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IDegAsp group

basal insulin plus pre-prandial insulin group

Arm Description

IDegAsp twice daily

basal insulin once or twice daily plus pre-prandial insulin

Outcomes

Primary Outcome Measures

HbA1c

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

Secondary Outcome Measures

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)).

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)

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

EQ-5D Health Questionnaire

the EQ-5D descriptive system The change from baseline after 16 weeks of treatment

Short Form 36 (SF-36)

The change from baseline after 16 weeks of treatment

Insulin dose

The change from baseline after 16 weeks of treatment

Full Information

NCT ID

NCT04965051

First Posted

July 7, 2021

Last Updated

July 7, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04965051

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 2021 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IDegAsp group

Arm Type

Experimental

Arm Description

IDegAsp twice daily

Arm Title

basal insulin plus pre-prandial insulin group

Arm Type

Active Comparator

Arm Description

basal insulin once or twice daily plus pre-prandial insulin

Intervention Type

Drug

Intervention Name(s)

insulin degludec/insulin aspart (IDegAsp)

Other Intervention Name(s)

Ryzodeg

Intervention Description

To evaluate the efficacy and safety of the IDegAsp in T1DM

Intervention Type

Drug

Intervention Name(s)

basal insulin plus pre-prandial insulin

Other Intervention Name(s)

Levemir/Lantus/Tresiba plus NovoLog/Humalog/Apidra

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1c

Description

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

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Time In Range (TIR)

Description

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 Frame

16 weeks

Title

Time to occurrence of treat to target

Description

Fasting glucose on treatment <7mmol/L and non-fasting glucose <10mmol/L, or TIR >70%) (SMBG or FCGM)

Time Frame

16 weeks

Title

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

Description

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

Time Frame

16 weeks

Title

EQ-5D Health Questionnaire

Description

the EQ-5D descriptive system The change from baseline after 16 weeks of treatment

Time Frame

16 weeks

Title

Short Form 36 (SF-36)

Description

The change from baseline after 16 weeks of treatment

Time Frame

16 weeks

Title

Insulin dose

Description

The change from baseline after 16 weeks of treatment

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuezhong Ren, MD

Phone

+86 0571 87783516

renyuez@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuezhong Ren, MD

Organizational Affiliation

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

2nd Affiliated Hospital, School of Medicine, Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuezhong Ren

Phone

+8657189713764

renyuez@zju.edu.cn

First Name & Middle Initial & Last Name & Degree

Yuezhong Z Ren, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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