Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Saxagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the subject Inclusion Criteria should be referred to STUDY: D168L00008. Briefly Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes Men or women who are 18 years of age. Patients should be drug naïve or treated with metformin alone on stable doses of for at least continues 8 weeks. HbA1c are between 7.5% and 11.0% Exclusion Criteria: All the subject Exclusion Criteria should be referred to STUDY: D168L00008. Briefly Pregnant or breastfeeding patients. Insulin therapy within one year of enrolment(with the exception of insulin therapy during a hospitalization or use in gestational diabetes). Previous treatment with any dipeptidyl peptidase-IV (DPP-IV) inhibitors or Glucagon-like peptide-1 (GLP-1) analogue. History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD). Treatment with systemic glucocorticoids other than replacement therapy. Inhaled,local injected and topical use of glucocorticoids is allowed. Treatment with strong cytochrome P450 inhibitors. Gastrointestinal surgery that could impact the absorption of study drug. Contraindications to therapy as outlined in the saxagliptin package insert. Hypersensitivity to saxagliptin Have a history of, or currently have, acute or chronic pancreatitis. Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study. Fasting plasma glucose >15mmol/l.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saxagliptin<br> | Drug: Saxagliptin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 weeks |