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Een dubbelblind, placebo-gecontroleerd fase 2 onderzoek naar de effecten van ARA 290 op neuropathische symptomen in patiënten met type 2 diabetes.

Conditions
type 2 diabetes mellitussmall fiber neuropathy (dunne vezel neuropathie)pain (pijn)eye exams (oogonderzoek)skin biopsy (huidbiopten)
Registration Number
NL-OMON21147
Lead Sponsor
eiden University Medical Center
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

1. Established diagnosis of diabetes mellitus type 2;

2. Screening HbA1c between 7.5 % and 10 % inclusive;

Exclusion Criteria

1. Clinically relevant abnormal history of physical and mental health other than conditions related to diabetes, as determined by medical history taking (as judged by the investigator);

2. Clinically relevant abnormal laboratory results, vital signs, or physical findings other than conditions related to diabetes (as judged by the investigator);

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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