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

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01768208

CCEMD016

Details and patient eligibility

About

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.

Enrollment: 569 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Exclusion Criteria should be referred to STUDY: D168L00008.

Briefly

1. Pregnant or breastfeeding patients.
2. Insulin therapy within one year of enrolment(with the exception of insulin therapy during a hospitalization or use in gestational diabetes).
3. Previous treatment with any dipeptidyl peptidase-IV (DPP-IV) inhibitors or Glucagon-like peptide-1 (GLP-1) analogue.
4. History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD).
5. Treatment with systemic glucocorticoids other than replacement therapy. Inhaled,local injected and topical use of glucocorticoids is allowed.
6. Treatment with strong cytochrome P450 inhibitors.
7. Gastrointestinal surgery that could impact the absorption of study drug.
8. Contraindications to therapy as outlined in the saxagliptin package insert.
9. Hypersensitivity to saxagliptin
10. Have a history of, or currently have, acute or chronic pancreatitis.
11. Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
12. 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.
13. Fasting plasma glucose >15mmol/l.

Trial design

569 participants in 1 patient group

Saxagliptin

Experimental group

Treatment:

Drug: Saxagliptin