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

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

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.

Study Overview

• Status: Unknown
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: HMS5552

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In this study, subjects with type 2 diabetes mellitus treated with HMS5552 were screened to meet the target of glucose control when they completed 52 or 28 weeks of HMS5552 treatment respectively.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HMS5552 treatment	Drug: HMS5552; To observe the progress of diabetes mellitus after 52 or 28 weeks of HMS5552 treatment for type 2 diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Changes of HbA1c	4 weeks
Fasting glucose	Changes of fasting glucose	4 weeks
Postprandial glucose	Changes of postprandial glucose	4 weeks
C peptide	Changes of C peptide	4-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNF-α	Changes of TNF-α	52 weeks
IL-6	Changes of IL-6	52 weeks
8-iso PGF2α	Changes of 8-iso PGF2α	52 weeks

Collaborators and Investigators

• Sponsor: Majianhua

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: September 15, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Glucose control; Glucokinase Activator
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KY20190530-01-KS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No