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

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ClinicalTrials.gov Identifier: NCT04965051
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


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 Name: 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 Name: Levemir/Lantus/Tresiba plus NovoLog/Humalog/Apidra




Primary Outcome Measures :
  1. HbA1c [ Time Frame: 16 weeks ]
    the change from baseline in HbA1c after 16 weeks of treatment in all patients


Secondary Outcome Measures :
  1. 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)).

  2. 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)

  3. 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

  4. EQ-5D Health Questionnaire [ Time Frame: 16 weeks ]
    the EQ-5D descriptive system The change from baseline after 16 weeks of treatment

  5. Short Form 36 (SF-36) [ Time Frame: 16 weeks ]
    The change from baseline after 16 weeks of treatment

  6. Insulin dose [ Time Frame: 16 weeks ]
    The change from baseline after 16 weeks of treatment



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965051


Contacts
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Contact: Yuezhong Ren, MD +86 0571 87783516 renyuez@zju.edu.cn

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Yuezhong Ren    +8657189713764    renyuez@zju.edu.cn   
Principal Investigator: Yuezhong Z Ren, MD         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Yuezhong Ren, MD 2nd Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04965051    
Other Study ID Numbers: 2021-0407
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Type 1 Diabetes
insulin degludec/insulin aspart
HbA1c
Time in Range
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs