A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

Steno Diabetes Centers

Status and phase: Unknown; Phase 4

Conditions: Nephropathy; Diabetes Mellitus; Blood Pressure

Treatments: Drug: placebo tablet; Drug: Spironolacton (hexalacton(R))

Study type: Interventional

Funder types: Other

Identifiers

NCT00843388

Eudra CT: 2008-004839-38

2306

Details and patient eligibility

About

A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 1 diabetes
• age 18-80 years
• microalbuminuria

Exclusion criteria

• blood pressure> 160/100 mmHg
• persistent macroalbuminuria
• pregnancy or in risc of this
• P-Potassium>5.7 mmol/l
• Eplerone treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

60 days treatment with tablet hexalacton 25 mg OD.

Treatment:

Drug: Spironolacton (hexalacton(R))

2

Placebo Comparator group

Description:

Inactive drug of 25 mg OD

Treatment:

Drug: placebo tablet