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
NCT number | NCT04965051 |
Other study ID # | 2021-0407 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2021 |
Est. completion date | December 2023 |
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).
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 |
Country | Name | City | State |
---|---|---|---|
China | 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
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 |
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