No registrations found.
ID
Source
Brief title
Health condition
Type 2 diabetes
High Albuminuria
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction in 24-hr urinary albumin excretion
Secondary outcome
To 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.
Background summary
Albuminuria 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
Study objective
- 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
Study design
Albuminuria and variability will be assessed after 6 weeks therapy
Intervention
Dapagliflozin 10 mg/day or placebo
S. Petrykiv
Groningen
The Netherlands
+31 50 363 2810
s.petrykiv@umcg.nl
S. Petrykiv
Groningen
The Netherlands
+31 50 363 2810
s.petrykiv@umcg.nl
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 criteria
Type 1 diabetes
Urinary albumin excretion > 3500 mg/day
Active malignancy
Pregnancy or breast feeding
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4295 |
| NTR-old | NTR4439 |
| Other | METc Universitair Medisch Centrum Groningen : 2014/111 |