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

NCT04091854 | Unknown

• 1 other identifier: KY20190530-01-KS-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes Mellitus

Keywords

Glucokinase Activator; Glucose control

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• TNF-α

  52 weeks

• IL-6

  52 weeks

• 8-iso PGF2α

  52 weeks

Study Arms (1)

HMS5552 treatment

Drug: HMS5552

Interventions

HMS5552 DRUG

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

HMS5552 treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Majianhua: lead

Study Sites (1)

Nanjing First hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

Dorzagliatin

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Endocrinology department, Clinical Professor

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 17, 2019
• Study Start: December 12, 2018
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 26, 2021

Record last verified: 2020-12

Locations

CN (1)