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

• Conditions: Type2 Diabetes Mellitus
• Interventions: Drug: HMS5552

• Registration Number: NCT04091854
• Lead Sponsor: Majianhua

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-15
• Study First Posted: 2019-09-17
• Status Verified: 2020-12
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HMS5552 treatment	HMS5552	-

Primary Outcome Measures

Name	Time	Method
HbA1c	4 weeks	Changes of HbA1c
Fasting glucose	4 weeks	Changes of fasting glucose
Postprandial glucose	4 weeks	Changes of postprandial glucose
C peptide	4-8 weeks	Changes of C peptide

Secondary Outcome Measures

Name	Time	Method
8-iso PGF2α	52 weeks	Changes of 8-iso PGF2α
TNF-α	52 weeks	Changes of TNF-α
IL-6	52 weeks	Changes of IL-6

Trial Locations

Locations (1)

Nanjing First hospital; 🇨🇳 Nanjing, Jiangsu, China