ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)

What Was Tested

The trial (phase 2) is built around ARA-290.

The study will also evaluate effects of ARA 290 on insulin sensitivity and serum levels of inflammatory agents, e.g. cytokines.

In addition, safety will be monitored by following parameters related to hematology, kidney and liver function and lipid levels.

It had two arms (groups): ARA 290 (experimental) and Placebo (placebo comparator).

Placebo, injected subcutaneously once every morning during 28 days,.

The registry classes the interventions as drug.

More on the Plan

Study Design: This is a single-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of ARA 290 on glucose homeostasis in persons with pre-diabetes or early, dietary treated type 2 diabetes.

The trial has two parallel arms with 12 subjects in each group, and with a 4-week-intervention period.

At screening, a baseline investigation will include a physical examination and the following tests: oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA1c).

Participating subjects meeting inclusion criteria, and not fulfilling any exclusion criterion on screening, will be randomized double-blind within one week following screening 1:1 to either treatment with ARA 290 or with placebo.

Who Took Part

Enrollment: 24 planned participants were the target.

It was open to people of any sex aged from 40 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained prior to any trial-related activities. Meeting criteria for impaired fasting glucose (IFG), impaired glucose tolerance (IGT), IGF+IFG, or type 2 diabetes at the screening OGTT. BMI (body mass index) ≤ 35 kg/m2. Males aged 40-75 years; women aged 50-75 years and in menopause. Able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: anticipated change in concomitant medication that may interfere with blood glucose homeostasis, such as systemic glucocorticoids, non-selective beta blockers and anabolic steroids; anti-diabetic (anti-hyperglycemic) medication of any kind; impaired renal function, defined as s-creatinine ≥ 125 μmol/l for men and ≥ 115 μmol/l for women.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this ARA-290 study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received ARA-290.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2013-10 with completion listed for 2014-06.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): oral glucose tolerance (time frame: 28 days). Insulin secretion (time frame: 28 days).

It also tracked 2 secondary outcomes, for example Insulin sensitivity and Inflammation.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ARA-290 in 24 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ARA-290 compound page, all human trials.