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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: metformin+empagliflozin+insulin glargine; Drug: IDegLira; Drug: premixed insulin analogues

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 Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of hypoglycemia incidence	Percentage of hypoglycemia incidence from month 0 to 3	Month 0 to 3
Percentage of adverse events	Percentage of adverse events from month 0 to 3	Month 0 to 3

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (ACTUAL): September 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Empagliflozin
• Other Study ID Numbers: 202206361

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No