Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients
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ClinicalTrials.gov Identifier: NCT01768208
Recruitment Status : Unknown
Verified June 2016 by Guang Ning, Shanghai Jiao Tong University School of Medicine. Recruitment status was: Active, not recruiting
First Posted : January 15, 2013
Last Update Posted : June 14, 2016
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
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.
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. [ Time Frame: 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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
All the subject Inclusion Criteria should be referred to STUDY: D168L00008.
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%
All the subject Exclusion Criteria should be referred to STUDY: D168L00008.
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.