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

NCT01768208 | Unknown Phase 4

• 1 other identifier: CCEMD016
• Study Type: interventional
• Target: 569
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Saxagliptin

EXPERIMENTAL

Drug: Saxagliptin

Interventions

Saxagliptin DRUG

Saxagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Briefly
• 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%

You may not qualify if:

• Briefly
• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the vice-president of Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: January 15, 2013
• Study Start: October 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CN (1)