Effect of premixed insulin combined with mulberry twig alkaloids tablet or metformin on blood glucose fluctuation in type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes patients with poor blood glucose control; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN20835488
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

2023 Results article in https://doi.org/10.3389/fendo.2023.1272112 (added 01/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-04
• Study Completion: 2023-07-20
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Aged between 18 and 70 years old, regardless of gender
2. Body mass index (BMI) between 19 and 30kg/m2
3. Diagnosed as type 2 diabetes according to the diagnostic criteria for type 2 diabetes formulated by the 1999 World Health Organization
4. Type 2 diabetes patients with poor blood glucose control 7% = HbA1c = 10%
5. Able to understand the procedures and methods of this clinical study, participate voluntarily and sign the informed consent form

Exclusion Criteria

1. Ineffective, allergy or intolerance to a-glucosidase inhibitors
2. Severe diabetic complications
3. Secondary diabetes mellitus, specific types of diabetes, type 1 diabetes
4. Chronic gastrointestinal dysfunction, obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, Cushing syndrome, acromegaly, etc
5. Patients with diseases that may worsen due to flatulence (such as Roeheld syndrome, severe hernia, intestinal obstruction, after gastrointestinal surgery and intestinal ulcer)
6. Unstable angina pectoris within half a year, have serious heart diseases and are likely to die in the treatment and follow-up period
7. People with mental and neurological disorders who cannot correctly express their will
8. Alcoholics, drug abusers and addicts
9. Women of childbearing age who are pregnant, lactating, intending to be pregnant or positive in a pregnancy test (urine HCG or blood HCG), and cannot take effective contraceptive measures during the test (effective contraceptive measures include sterilization, intrauterine device, oral contraceptives etc
10. Those who have participated in clinical trials of other drugs or medical devices in the past three months

Study & Design

• Study Type: Interventional
• Study Design: Not specified