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

NCT05545800 | Unknown Phase 3

• 1 other identifier: 202206361
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Percentage of hypoglycemia incidence

  Month 0 to 3

• Percentage of adverse events

  Month 0 to 3

Study Arms (3)

metformin+empagliflozin+insulin glargine

EXPERIMENTAL

metformin+empagliflozin+insulin glargine

Drug: metformin+empagliflozin+insulin glargine

IDegLira

EXPERIMENTAL

IDegLira

Drug: IDegLira

premixed insulin analogues

ACTIVE COMPARATOR

premixed insulin analogues

Drug: premixed insulin analogues

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.

metformin+empagliflozin+insulin glargine

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.

IDegLira

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.

premixed insulin analogues

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

IDegLira

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jing Wu

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wu

CONTACT

+86-13574120508; wujing0731@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (1)