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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiangya Hospital of Central South University
• Treatments: Empagliflozin; Insulin; Insulin Glargine; Insulin, Globin Zinc; Metformin

Criteria

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