Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients
This study is currently recruiting participants.
Verified January 2013 by Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
First received: December 13, 2012
Last updated: January 14, 2013
Last verified: January 2013
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.
Type 2 Diabetes
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders 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.
- Fasting plasma glucose >15mmol/l.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768208
|Shanghai Jiao Tong University School of Medicine
|Shanghai, Shanghai, China, 200025 |
|Contact: Guang Ning, MD, PHD 64370045 ext 665340 firstname.lastname@example.org |
Shanghai Jiao Tong University School of Medicine
No publications provided
||Guang Ning, the vice-president of Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai Jiao Tong University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 13, 2012
||January 14, 2013
||China: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs