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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04091854
Other study ID # KY20190530-01-KS-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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