Type 2 Diabetes
Conditions
Brief summary
This study is an open-label, cohort study to evaluate the potential mechanisms of Saxagliptin in the treatment of patients with type 2 diabetes (T2DM) using a comprehensive metabolomic method, in combination with fingerprint analysis and target analysis. It is a sub-study of STUDY: D168L00008.
Interventions
DRUGSaxagliptin
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All the subject Inclusion Criteria should be referred to STUDY: D168L00008. Briefly 1. Provision of informed consent prior to any study specific procedures 2. Diagnosed with type 2 diabetes 3. Men or women who are 18 years of age. 4. Patients should be drug naïve or treated with metformin alone on stable doses of for at least continues 8 weeks. 5. HbA1c are between 7.5% and 11.0%
Exclusion criteria
* All the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of the study is to evaluate the changes in the metabolomic parameters before and after Saxagliptin treatment in type 2 diabetic patients. | 24 weeks | The primary objective of the study is to compare the different metabolomic profiling at baseline (before treatment) and at the end of the study drug administration(24 weeks) using a Liquid Chromatography-Mass Spectrometry (LC-MS) analysis. |
Countries
China
Outcome results
None listed