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

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ClinicalTrials.gov Identifier: NCT01768208
Recruitment Status : Active, not recruiting
First Posted : January 15, 2013
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):
Guang Ning, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Saxagliptin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 569 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : October 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Saxagliptin Drug: Saxagliptin

Primary Outcome Measures :
  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. [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All the subject Inclusion Criteria should be referred to STUDY: D168L00008.


  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.


  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768208

China, Shanghai
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine

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
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

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