Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM
NCT ID: NCT04965051
Last Updated: 2021-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-08-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IDegAsp group
IDegAsp twice daily
insulin degludec/insulin aspart (IDegAsp)
To evaluate the efficacy and safety of the IDegAsp in T1DM
basal insulin plus pre-prandial insulin group
basal insulin once or twice daily plus pre-prandial insulin
basal insulin plus pre-prandial insulin
To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Yuezhong Ren, MD
Role: PRINCIPAL_INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-0407
Identifier Type: -
Identifier Source: org_study_id
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