A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus

Summary

A randomized open, positive parallel controlled clinical study design was adopted. Participants were randomly assigned 1:1 according to inclusion criteria and exclusion criteria into two treatment regiments: Delu insulin liraglupeptide injection group and premixed insulin (or premixed insulin analogue). After fasting blood glucose was controlled at 7.5mmol /l in the morning, blood glucose was monitored by CGM (14d), and the Time in Range (3.9-10 mmol/l) was compared. Glycated albumin was measured and stool samples were taken before treatment and at 4 weeks.

Conditions

• Type 2 Diabetic Patients

Interventions

DRUG

Degludec insulin

The pre-mixed human insulin or insulin analogues were stopped, and the treatment was switched to Delgol insulin liraglutide injection. The initial dose was subcutaneous injection of 80% (not more than 16 units) of the full daily dose of medium-acting insulin in the original insulin, once a day, and the dose of Delgol insulin liraglutide injection was adjusted according to the fasting blood glucose level. Example 1: If the patient is currently using Novorin 30 20iu bid, the conversion calculation is 40\*70%\*80%=22.4 units, which should be 16 units; In example 2, the patient applied eubrine 50 20 IU bid, and the conversion calculation was 40\*50%\*80%=16 units.

Sponsors & Collaborators

• Taizhou First People's Hospital

  collaborator OTHER

• Wenzhou Central Hospital

  collaborator OTHER

• Wenzhou People's Hospital

  collaborator OTHER

• Chaohu Hospital of Anhui Medical University

  collaborator OTHER

• Affiliated Zhoushan Hospital of Wenzhou Medical University

  collaborator OTHER

• Yiwu Central Hospital

  collaborator OTHER

• Jinhua Municipal Central Hospital

  collaborator OTHER

• Dongyang People's Hospital

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• Jinhua People's Hospital

  collaborator OTHER

• Wuhu City Second People's Hospital

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Beijing Tsinghua Chang Gung Hospital

  lead OTHER

Principal Investigators

• WenHui ZHAO · Beijing Tsinghua Chang Gung Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-20

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Drug

Yes

Countries

• China

Study Locations