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
Verified date | December 2020 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Nanjing First hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Majianhua |
China,
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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