A study the effects of ARA 290 administered subcutaneously on nerve disease in patients with type 2 diabetes

• Conditions: Diabetes type 2: neuropathic symptoms; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-005590-32-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-10
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Established diagnosis of diabetes mellitus type 2
Screening HbA1c between 7.5 % and 10 % inclusive [retest of HbA1c allowed for patients with borderline values]
Quantitative sensory testing shows allodynia and altered temperature thresholds
Spontaneous discomfort level of 6 or greater on Pain Now (Pain Detect; 0 (least discomfort)-10 (worst discomfort))
and small fiber neuropathy screening list (SFNSL; [1]) > 22,
or spontaneous discomfort level on Pain Now (Pain Detect) < 5 and SFNSL > 44 at screening AND at first dosing visit.
Discomfort defined as distal pain/discomfort plus one of the following: 1) paresthesia 2) burning/painful feet worsening at night, or 3) intolerance of sheets or clothes touching the legs or feet
Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff
Be willing to comply with study restrictions
Be willing to check in with the study center via the telephone
Between 18 and 70 years of age (inclusive)
Body Mass Index (BMI) < 40 kg/m2 (inclusive)
If female of childbearing potential, a negative urine pregnancy test at screening and acceptable contraception will be maintained during the screening and dosing period and 1 month beyond. Acceptable contraception consists of hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient’s usual menstrual cycle period) before study entry, intrauterine device (IUD), or double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
Able to complete self-administered questionnaires (RAND-36, SFNSL, Pain Detect)
Refrigerator at home for storage of study medication.

Amendments (May2014): HbA1c >8% at screening, able to visit the hospital sober
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 88

Exclusion Criteria

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)
Clinically relevant abnormal laboratory results, vital signs, or physical findings other than conditions related to diabetes (as judged by the investigator)
Known clinically relevant abnormalities in ECG (as judged by the investigator)
Episodes of significant hypoglycemia (as judged by the investigator)
Illicit drug abuse or excessive alcohol consumption (as judged by the investigator)
History of serious malignancy (as judged by the investigator)
History of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food (as judged by the investigator)
Subjects that received a vaccination or immunization within the month prior to screening.
Anti-TNF therapy or other biological anti-inflammatory agents administered within the 6 months prior to screening.
Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year
Inadequate venous accessibility as judged by clinicians (physician or nurse)
Inability or unwillingness to self-administer ARA 290 via subcutaneous injections (or not have access to home health care for assistance in administration; also see 6.9)
If female, pregnant or breast-feeding
Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified