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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: IDegLira; Drug: metformin+empagliflozin+insulin glargine; Drug: premixed insulin analogues

• Registration Number: NCT05545800
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-01
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDegLira	IDegLira	IDegLira
metformin+empagliflozin+insulin glargine	metformin+empagliflozin+insulin glargine	metformin+empagliflozin+insulin glargine
premixed insulin analogues	premixed insulin analogues	premixed insulin analogues

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in HbA1c	Month 0 to 3	mean change from baseline in HbA1c after 3-months of treatment.
Percentage of patients achieving HbA1c <7%	Month 0 to 3	Percentage of patients achieving HbA1c \<7% after 3-months of treatment.
Amplitude of glycemic excursions	Month 0 to 3	Amplitude of glycemic excursions from month 0 to 3

Secondary Outcome Measures

Name	Time	Method
Percentage of hypoglycemia incidence	Month 0 to 3	Percentage of hypoglycemia incidence from month 0 to 3
Percentage of adverse events	Month 0 to 3	Percentage of adverse events from month 0 to 3

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China