Clinical trial
Effectiveness of Sitagliptin for the Treatment of Newly Diagnosed Type 2 Diabetes
Name
2020-DM-Sitagliptin
Description
Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment for 3 months. The gut microbiome of the participants before and after the treatment and the effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.
Trial arms
Trial start
2020-01-01
Estimated PCD
2025-06-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Sitagliptin 100mg
Sitagliptin 100mg Qd
Arms:
sitagliptin
Size
50
Primary endpoint
HbA1c change
Changes in HbA1c from baseline at 1 month and 3 months during follow-up
Eligibility criteria
Inclusion Criteria:
* Patients 18-65 years old newly diagnosed with type 2 diabetes
* HbA1c ≥ 7%
Exclusion Criteria:
* The positive of diabetes antibodies
* Anti-diabetic drugs therapy before participation
* Pancreatitis
* Coronary artery disease
* Liver function impairment
* Renal function impairment
* History of intestinal surgery
* Chronic hypoxic diseases (emphysema and cor pulmonale)
* Infectious disease
* Hematological disease
* Systemic inflammatory disease
* Cancer
* Pregnant
* Ingesting agents known to influence glucose or lipid metabolism;
* Any antibiotics or probiotics in the past three months prior to the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-07-28
1 organization
1 product
1 indication
Organization
Beijing Chao Yang HospitalProduct
SitagliptinIndication
Type 2 Diabetes