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Het effect van een DPP-4 remmer op de reactie van het lichaam bij een hypoglykemie bij patiŽnten met type 1 diabetes.


- candidate number8543
- NTR NumberNTR2563
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2010
- Secondary IDs10/202 MEC AMC
- Public TitleHet effect van een DPP-4 remmer op de reactie van het lichaam bij een hypoglykemie bij patiŽnten met type 1 diabetes.
- Scientific TitleDipeptidyl peptidase-4 inhibitors and Alpha-cell Recovery.
- ACRONYMDARE
- hypothesisWe hypothesize that treatment with a DPP-4 inhibitor will enhance the glucagon response to hypoglycaemia in patients with type 1 diabetes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I), Hypoglycemia, Glucagon
- Inclusion criteria1. Male;
2. Age 18-40 years;
3. Type 1 Diabetes Mellitus 5-20 years duration;
4. C-peptide negative;
5. Willing and able to give written informed consent.
- Exclusion criteria1. Impaired awareness of hypoglycaemia;
2. BMI > 27 kg/m2;
3. Evidence of severe diabetes complications (autonomic neuropathy, macroalbuminuria, proliferative retinopathy);
4. Acute illness within 3 months before the study;
5. Significant renal impairment (creatinine clearance <50ml/min);
6. Use of beta-adrenoreceptor blockers;
7. Cardiac history (previous arrhythmia);
8. History of epilepsy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-nov-2011
- Target number of participants16
- InterventionsThe 16 type 1 patients will be randomised to one of two treatment sequences: DPP-4 inhibitor followed by placebo or placebo followed by a DPP-4 inhibitor. Each treatment period lasts 6 weeks, so all patients will receive treatment for 12 weeks in total. Induction of hypoglycaemia will take place at 0 weeks, 6 weeks and 12 weeks to determine the glucagon response.
- Primary outcomeGlucagon response to insulin induced hypoglycaemia measured as AUC (area under the curve).
- Secondary outcome1. Other counterregulatory hormone responses to insulin induced hypoglycaemia measured as AUC;
2. Symptomatic hormone responses to insulin induced hypoglycaemia.
- Timepoints0, 6 and 12 weeks.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES F. Holleman
- CONTACT for SCIENTIFIC QUERIES F. Holleman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Merck Sharp & Dohme BV (MSD)
- PublicationsN/A
- Brief summaryHypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory response to hypoglycaemia, with glucagon as the most important mediator, is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus increasing the risk of hypoglycaemia. DPP-4 inhibitors augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. We hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will recover the alpha cell response to hypoglycaemia.
- Main changes (audit trail)
- RECORD8-okt-2010 - 9-mrt-2012


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