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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40930

Enrollment

Registered

2014-03-27

Start date

2014-08-06

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Albuminuria in patients with type 2 diabetes

Interventions

Dapagliflozin tablets and matching placebo*s are provided by Bristol-Myers-Squibb. Patients take 10 mg dapagliflozin (once daily) or matching placebo according to randomised treatment scheme. Study

on those days, the study drug will be taken after the patient visit.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age >=18 and = 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

Measure	Time frame
Primary study goal is to assess the change from baseline in 24-hr albuminuria with dapagliflozin for six weeks relative to placebo treatment in patients with diabetes and albuminuria > 100 mg/day on stable ACEi or ARB treatment.	—

Secondary

Measure	Time frame
Secondary Objective(s): 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.	—

Measure

Time frame

Secondary Objective(s): 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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)