The Progress of Diabetes Mellitus After HMS5552 Treatment in Type 2 Diabetes Mellitus

Type2 Diabetes Mellitus Clinical Trial

Official title:

A Study to Observe the Progress of Diabetes Mellitus After 52 or 28 Weeks of HMS5552 Treatment for Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04091854
• Other study ID #: KY20190530-01-KS-01
• Status: Active, not recruiting
• Start date: December 12, 2018
• Est. completion date: March 2022

Study information

• Verified date: December 2020
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

At present, there are few studies on the clinical remission rate of diabetes after one year discontinuation of oral hypoglycemic drugs after intensive treatment. HMS5552 is a kind of GKA hypoglycemic drug. This study intends to observe the clinical remission rate of diabetes mellitus, beta cell function and blood sugar fluctuation of patients with type 2 diabetes mellitus who have been treated with HMS5552 for 52W or 28W and whose glucose control is up to the standard.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Complete HMS5552 treatment and safety visit;
• HbA1c < 8.0% was detected in our laboratory;
• Researchers judged the stability of glucose control based on the data of subjects'visits during HMS5552 treatment and the indicators of our hospital;
• Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise;
• Willing to sign written informed consent and abide by the research program.

Exclusion Criteria:

• There was a state of illness in the subjects who could not complete the follow-up during the observation period.
• The researchers judged that subjects'compliance with HMS5552 was affected during treatment.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• HMS5552
To observe the progress of diabetes mellitus after 52 or 28 weeks of HMS5552 treatment for type 2 diabetes mellitus

Locations

Country	Name	City	State
China	Nanjing First hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Majianhua

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Changes of HbA1c	4 weeks
Primary	Fasting glucose	Changes of fasting glucose	4 weeks
Primary	Postprandial glucose	Changes of postprandial glucose	4 weeks
Primary	C peptide	Changes of C peptide	4-8 weeks
Secondary	TNF-a	Changes of TNF-a	52 weeks
Secondary	IL-6	Changes of IL-6	52 weeks
Secondary	8-iso PGF2a	Changes of 8-iso PGF2a	52 weeks