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

Sponsor
Xiangya Hospital of Central South University
Study ID
NCT05545800
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • metformin+empagliflozin+insulin glargine — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Sep 2022
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: metformin+empagliflozin+insulin glargine
    metformin+empagliflozin+insulin glargine
  • Experimental: IDegLira
    IDegLira
  • Active Comparator: premixed insulin analogues
    premixed insulin analogues

Primary Outcome Measure

Mean Change From Baseline in HbA1c [ Time Frame: Month 0 to 3 ]

Central Contacts

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