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

Sponsor

Xiangya Hospital of Central South University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05545800

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: metformin+empagliflozin+insulin glargine Drug: IDegLira Drug: premixed insulin analogues	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metformin+empagliflozin+insulin glargine metformin+empagliflozin+insulin glargine	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.
Experimental: IDegLira IDegLira	Drug: 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.
Active Comparator: premixed insulin analogues premixed insulin analogues	Drug: 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.

Arm

Intervention/Treatment

Experimental: metformin+empagliflozin+insulin glargine

metformin+empagliflozin+insulin glargine

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.

Experimental: IDegLira

IDegLira

Drug: 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.

Active Comparator: premixed insulin analogues

premixed insulin analogues

Drug: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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