Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM
- Conditions
- Type 1 Diabetes Mellitus With Diabetic GastroparesisHbA1cTime in Range
- Interventions
- Drug: insulin degludec/insulin aspart (IDegAsp)Drug: basal insulin plus pre-prandial insulin
- Registration Number
- NCT04965051
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDegAsp group insulin degludec/insulin aspart (IDegAsp) IDegAsp twice daily basal insulin plus pre-prandial insulin group basal insulin plus pre-prandial insulin basal insulin once or twice daily plus pre-prandial insulin
- Primary Outcome Measures
Name Time Method HbA1c 16 weeks the change from baseline in HbA1c after 16 weeks of treatment in all patients
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China