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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2016 |
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Main ID: |
NCT01768208 |
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Date of registration:
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13/12/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Metabolomic Variations in the Saxagliptin-Treated Type 2 Diabetes Mellitus Patients
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Scientific title:
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Date of first enrolment:
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October 2012 |
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Target sample size:
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569 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01768208 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 4
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Drug: Saxagliptin
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Primary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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