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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Efficacy and Safety Of Different Hypoglycemic Regimens Compared With Premixed Insulin In Patients With Type 2 Diabetes Receiving Short-term Intensive Insulin Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545800
• Other study ID #: 202206361
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2022
• Source: Xiangya Hospital of Central South University
• Contact: Jing Wu
• Phone: +86-13574120508
• Email: wujing0731[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• metformin+empagliflozin+insulin glargine
Randomization was performed with the use of a computer-generated system provided by the sponsor. The dose of metformin will be initiated at 0.5 grams three times a day (the maximum dose is 2g/day); the dose of empagliflozin will be 10 milligrams once a day; insulin glargine will be received once daily at bedtime and the dose will be initiated at the 50% of 0.4-0.5 units/kg/day. All groups received counseling on lifestyle modification.
• IDegLira
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients will be initiated on 16 units (16 units degludec/0.58 mg liraglutide) and titrated twice weekly. The maximum dose of IDegLira was 50 units (50 units degludec/1.8 mg liraglutide). All groups received counseling on lifestyle modification.
• premixed insulin analogues
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients will received twice a day. The total daily insulin dose will be initiated at 0.4-0.5 units/kg/day and adjusted according to the plasma glucose. All groups received counseling on lifestyle modification.

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in HbA1c	mean change from baseline in HbA1c after 3-months of treatment.	Month 0 to 3
Primary	Percentage of patients achieving HbA1c <7%	Percentage of patients achieving HbA1c <7% after 3-months of treatment.	Month 0 to 3
Primary	Amplitude of glycemic excursions	Amplitude of glycemic excursions from month 0 to 3	Month 0 to 3
Secondary	Percentage of hypoglycemia incidence	Percentage of hypoglycemia incidence from month 0 to 3	Month 0 to 3
Secondary	Percentage of adverse events	Percentage of adverse events from month 0 to 3	Month 0 to 3