Study to Evaluate the Efficacy and Safety of Daglutril Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension

A Randomized, Double-Blind, Placebo Controlled, Two-Treatment and Two-Period Cross-Over, Mono-Center Study to Evaluate the Efficacy and Safety of Daglutril 300 mg Once Daily Compared to Placebo on Top of Losartan in Type 2 Diabetics With Overt Nephropathy and Well Controlled Hypertension

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160225

Enrollment

Unknown

Registered

2005-09-12

Start date

2005-07-31

Completion date

Unknown

Last updated

2007-11-14

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

Conditions

Hypertension

Keywords

blood pressure, diabetic nephropathy, proteinuria

Brief summary

This study is to evaluate the end of treatment effect of Daglutril compared to placebo on top of losartan.

Interventions

DRUGDaglutril

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* treated with optimized dose of losartan (constant dose for at least four weeks before randomization and throughout the whole study period) for at least four weeks * urinary albumin excretion ≥ 20 and \< 1000 µg/min * sitting systolic/diastolic blood pressure (SBP/DBP) \< 140/90 mmHg at the end of placebo run-in phase

Exclusion criteria

* known secondary hypertension * decompensated congestive heart failure

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026