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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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12 December 2020 |
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Main ID: |
NCT01922817 |
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Date of registration:
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06/08/2013 |
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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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DPP4inhibitors in Type 1 Diabetes
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Scientific title:
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A Dipeptidyl Peptidase 4 (DPP-4) Inhibitor in Type 1 Diabetes |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01922817 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria;
- Type 1 diabetes over 5 years duration
- HbA1c less than 10%
- Age 18 and over
- Current use of intensive insulin therapy (injections or pump)
- BMI 19-35
- Ability to give written informed consent to participate in the study
Exclusion criteria;
- Previous history of pancreatic disease/cancer
- Significant renal disease estimated glomerular filtration rate (eGFR) less than 50
- Significant microvascular disease
- Personal/family history of Medullary thyroid cancer
- Personal/family history of multiple endocrine neoplasia (MEN) Type 2
- Moderate/Severe hepatic impairment
- Pregnancy or breast feeding
- History of epilepsy/hypoglycaemia induced seizure
- Those on any other hypoglycaemia drug apart from insulin for their diabetes.
- Currently on CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital,
phenytoin, rifampicin
- Currently on CYP3A4 inhibitors like ketoconazole, diltiazem
- Less than 30 days since participation in another drug trial or longer depending on the
drug half life.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypoglycaemia
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Type 1 Diabetes
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Intervention(s)
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Drug: Saxagliptin
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Primary Outcome(s)
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Magnitude of epinephrine release at 2.5mmol/L
[Time Frame: During hyperinsulinaemic hypoglycaemia clamp]
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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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