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

Type 2 Diabetes Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01768208
• Other study ID #: CCEMD016
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 13, 2012
• Last updated: June 12, 2016
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 569
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No