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IMPROVE

A study to assess the anti-albuminuric effects and variability in response to dapagliflozin in subjects with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23733
Enrollment
36
Registered
2014-02-16
Start date
2014-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes High Albuminuria

Interventions

Dapagliflozin 10 mg/day or placebo

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Age ≥18 and ≤75 years -Diagnosis of type 2 diabetes mellitus -HbA1c ≥ 6.6% and 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

Exclusion criteria: Type 1 diabetes Urinary albumin excretion > 3500 mg/day Active malignancy Pregnancy or breast feeding

Design outcomes

Primary

MeasureTime frame
Reduction in 24-hr urinary albumin excretion

Secondary

MeasureTime frame
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.

Contacts

Public ContactS. Petrykiv

University Medical Center Groningen

s.petrykiv@umcg.nl+31 50 363 2810

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)