search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


IMPROVE


- candidate number16475
- NTR NumberNTR4439
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2014
- Secondary IDs2014/111 METc Universitair Medisch Centrum Groningen
- Public TitleIMPROVE
- Scientific TitleA study to assess the anti-albuminuric effects and variability in response to dapagliflozin in subjects with type 2 diabetes
- ACRONYMIMPROVE
- hypothesis- Dapagliflozin decreases albuminuria - The response to dapagliflozin is variable in albuminuria - The response in blood glucose, blood pressure, body weight and albuminuria varies within an individual
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Albuminuria
- Inclusion criteria-Age ≥18 and ≤75 years -Diagnosis of type 2 diabetes mellitus -HbA1c ≥ 6.6% and <11.0% -Urinary albumin excretion > 100 mg/g -On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization -On a stable dose of blood glucose lowering medication for at least 4 weeks prior to randomization -eGFR ≥ 45 mL/min/1.73m2 -Willing to sign informed consent
- Exclusion criteriaType 1 diabetes Urinary albumin excretion > 3500 mg/day Active malignancy Pregnancy or breast feeding
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-feb-2016
- Target number of participants36
- InterventionsDapagliflozin 10 mg/day or placebo
- Primary outcomeReduction in 24-hr urinary albumin excretion
- Secondary outcomeTo assess: -To assess the within-patient variability in HbA1c, 24-hr blood pressure, body weight, and albuminuria response to dapagliflozin. -To assess the between-patient variability in HbA1c, 24-hr blood pressure, body weight, and albuminuria response to dapagliflozin. -The variability in HbA1c, blood pressure, body weight, and albuminuria in response to dapagliflozin during the first and second treatment period.
- TimepointsAlbuminuria and variability will be assessed after 6 weeks therapy
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES S. Petrykiv
- CONTACT for SCIENTIFIC QUERIES H. Lambers Heerspink
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publicationsn/a
- Brief summaryAlbuminuria is a risk marker of renal and cardiovascular disease progression. The variability in reponse with drugs that decrease albuminuria is large. This study is designed to assess the anti-albuminuric effects of dapagliflozin, a sodium-glucose transport inhibitor, and the variability in drug response
- Main changes (audit trail)
- RECORD16-feb-2014 - 7-apr-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl