Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 September 15, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action