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

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Drug: Saxagliptin

• Registration Number: NCT01768208
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-15
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-12
• Last Update Posted: 2016-06-14
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 569

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saxagliptin	Saxagliptin	-

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China