Clinical trial NCT05545800: Efficacy and Safety Of Different Regimens In Patients With Type 2 Diabetes Receiving Intensive Insulin Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline in HbA1c
timeFrame: Month 0 to 3
measure: Percentage of patients achieving HbA1c <7%
timeFrame: Month 0 to 3
measure: Amplitude of glycemic excursions
timeFrame: Month 0 to 3
Secondary outcomes:
measure: Percentage of hypoglycemia incidence
timeFrame: Month 0 to 3
measure: Percentage of adverse events
timeFrame: Month 0 to 3
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Jing Wu
role: PRINCIPAL_INVESTIGATOR
References: