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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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23 March 2015 |
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Main ID: |
NCT02386943 |
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Date of registration:
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07/03/2015 |
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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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Study on Exploring the Effect of DPP-4 Inhibitors on ß-cell Function by Using the Two-step Hyperglycemic Clamp
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Scientific title:
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An Open-label, Randomized,Three-way Cross-over, Single Dose Study to Explore the Effect of DPP-4 Inhibitors on ß-cell Function by Using the Two-step Hyperglycemic Clamp |
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Date of first enrolment:
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December 2013 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02386943 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Contacts
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Name:
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Ning Guang, MD,PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Guang Ning, MD. PHD |
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Address:
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Telephone:
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+86021-64370045 |
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Email:
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Affiliation:
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Name:
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Guang Ning, MD. PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shanghai Jiao Tong University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 40-60 years old;
2. Diagnosed as T2DM according to the 1999 World Health Organization criteria within 2
years;
3. Free of any antihypoglycemia therapy ever;
4. No weight fluctuation greater than 5% in late 3 months.
5. Understand and voluntarily sign an informed consent document.
6. Good study compliance.
Exclusion Criteria:
1. With any significant medical condition (within 3 years), laboratory abnormality, or
psychiatric illness that would prevent the subject from participating in the study;
2. Used any prescribed systemic or topical medication within 30 days of the first dose
administration;
3. Any medical or surgical conditions possibly affecting study drug absorption,
distribution, metabolism and excretion;
4. Participated in a clinical study involving administration of an investigational drug
within 90 days preceding the first dose administration or within five half-lives of
the first dose administration (whichever is longer);
5. Donated blood or plasma or had any other significant blood loss within 2 months
preceding the first dose administration;
6. History of multiple drug allergies;
7. Any clinically significant allergic disease;
8. Recently drug or alcohol abuse (>35 unit/week, 1 unit=8g alcohol @ 1 standard drink @
250ml beer @ 140ml wine @ 25ml strong alcohol drink like whiskey); Smokers or users
of other tobacco products in the 3 months prior to screening.
Age minimum:
40 Years
Age maximum:
60 Years
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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Drug: Sitagliptin
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Drug: Blank control
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Primary Outcome(s)
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ß-cell function (measurement of insulin and c-peptide during the clamp study)
[Time Frame: 15 months]
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Secondary Outcome(s)
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a-cell function (measurement of glucagon during the clamp study)
[Time Frame: 15 months]
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Incretin effect (measurement of active GLP-1 during the clamp study)
[Time Frame: 15 months]
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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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