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Trial · Interventional

Status unknownPhase 2Registry data

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

NCTNCT01933529 (opens ClinicalTrials.gov in a new tab)Other idAPCP-115Other id2012-003207-35

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
24 participants (estimated)
Sponsor
Claes-Göran Östenson · Other
Design
Randomized · Triple masking
Countries
1 country

Sweden

Start
Oct 2013
Primary completion
Jun 2014
Completion
Dec 2015 (estimated)
First posted
2 Sept 2013 (estimated)
Last update posted
3 Sept 2015 (estimated)
Conditions
Diabetes Type 2 · Impaired Glucose Tolerance · Impaired Fasting Glucose

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 2

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

    NCT01933529

    Oct 2013 to est. Dec 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether a non-hematopoietic erythropoietin analogue, ARA 290, exerts beneficial effects on blood glucose levels and insulin secretion in persons with prediabetes (impaired glucose tolerance, IGT, or impaired fasting glucose, IFG), or drug-naive type 2 diabetes. 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.

Interventions

  • ARA 290Drug

Arms2

  • Experimental

    ARA 290

    ARA 290, 4.0 mg, injected subcutaneously once every morning during 28 days.

  • Placebo comparator

    Placebo

    Placebo, injected subcutaneously once every morning during 28 days,

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. oral glucose tolerance

    Time frame · 28 days

    Registry description

    Oral glucose tolerance tests are performed before and after 2 and 4 weeks of treatment. In addition, glucose tolerance will be monitored by checking glycosylated hemoglobin (HbA1c) at the same timepoints, and the participants will perform home blood glucose testing one day every week at home.

  2. Insulin secretion

    Time frame · 28 days

    Registry description

    Plasma insulin levels will be measured at the oral glucose tolerance tests. In addition, insulin secretion will be assessed by HOMA-beta, using fasting glucose and insulin values.

Secondary outcomes(2)
  1. Insulin sensitivity

    Time frame · 28 days

    Registry description

    Insulin sensitivity will be assessed by the HOMA-IR, using fasting glucose and insulin levels at the oral glucose tolerance tests.

  2. Inflammation

    Time frame · 28 days

    Registry description

    Assessment of cytokine levels in serum is reduced by ARA290 treatment.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. IFG = fasting P-glucose 5.6-6.9 mmol/L and 2 hr P-glucose \< 7.8 mmol/L; IGT = fasting P-glucose \<5.6 mmol/L and 2 hr P-glucose in OGTT 7.8-11.0 mmol/L;diabetes = fasting P-glucose ≥ 7.0 mmol/L and/or 2 hr P-glucose ≥ 11.1 mmol/L. * Fasting P-glucose ≤ 9 mmol/L. * 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 * Refrigerator at home for storage of study medication Exclusion Criteria: * 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. * Impaired hepatic function defined as plasma alanine aminotransferase (P-ALT) ≥ three times the upper reference limit. * Cardiac disease defined as unstable angina pectoris, or myocardial infarction within the last 6 months, or congestive heart failure NYHA (New York Heart Association) class III or IV. * Cerebral stroke within the last 6 months. * Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg). * Cancer diagnosed and/or treated within the last 5 years. * Females of childbearing potential. * Known or suspected abuse of alcohol or narcotic drugs. * Patients should not have received a vaccination or immunization within the month prior to screening * The use of Anti-TNF (anti-tumour necrosis factor) therapy or other biological anti-inflammatory agents administered within 3 months prior to screening is not allowed * The use of erythropoiesis stimulating agents within the two months prior to screening or during the trial is not allowed. * Administration of an investigational drug trial in the 3 months prior to administration of the initial dose of investigational medicinal product or more than 4 times per year.

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