Efficacy and Safety Of Different Regimens In Patients With Type 2 Diabetes Receiving Intensive Insulin Therapy

Central South University

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: IDegLira; Drug: premixed insulin analogues; Drug: metformin+empagliflozin+insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT05545800

202206361

Details and patient eligibility

About

The purpose of this studay is to compare the efficacy of different hypoglycemic regimens versus twice-daily premixed insulin in type 2 diabetes mellitus (T2DM) patients after short-term ntensive Insulin Therapy by using continuous glucose monitoring.

Full description

This randomized, positive-controlled, open-label, parallel-group study will enroll approximately 78 male and female patients aged 18-70 years with poorly-controlled T2DM (HbA1c >9% or FBS>11.1mmol/L) after short-term intensive insulin therapy. Eligible patients will then be randomized in a 1:1:1 ratio to insulin glargine plus OADs or twice-daily premixed insulin or Insulin Degludec & Liraglutide for 3 months with metformin maintained throughout the study in both treatment groups. All the patients will wear CGM during short-term intensive insulin therapy and after treatment for 7 days. The primary endpoint is plasma glucose change from baseline to month 3. Secondary endpoints include assessment of fasting plasma glucose, total daily insulin dose, hypoglycemia incidence, body weight change, adverse events, and patient satisfaction.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 18-70 years with poorly-controlled T2DM (World Health Organization diagnostic criteria)
• BMI 21~32Kg/m2
• duration of T2DM more than 1 year
• FPG≥11.1mmol/L or HbA1c ≥9% for three months
• fasting C-peptide >1 ng/mL

Exclusion criteria

• acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 1 month;
• impaired renal function,defined as (but not limited to) serum creatinine levels ≥1.5 mg/dL for males and ≥1.4 mg/dL for females, or the presence of macroproteinuria (> 2 g/day)
• pregnancy
• inability to perform self-monitoring of BG (SMBG)
• acute disease or surgery in the past 3months or preparation for the surgey

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 3 patient groups

metformin+empagliflozin+insulin glargine

Experimental group

Description:

metformin+empagliflozin+insulin glargine

Treatment:

Drug: metformin+empagliflozin+insulin glargine

IDegLira

Experimental group

Description:

IDegLira

Treatment:

Drug: IDegLira

premixed insulin analogues

Active Comparator group

Description:

premixed insulin analogues

Treatment:

Drug: premixed insulin analogues