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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01768208
First received: December 13, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Saxagliptin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1708
Study Start Date: October 2012
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saxagliptin Drug: Saxagliptin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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

Contacts
Contact: Guang Ning, MD, PHD 64370045 ext 665340 guangning@medmail.com.cn

Locations
China, Shanghai
Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, MD, PHD    64370045 ext 665340    guangning@medmail.com.cn   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Guang Ning, the vice-president of Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01768208     History of Changes
Other Study ID Numbers: CCEMD016
Study First Received: December 13, 2012
Last Updated: January 14, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Saxagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014