Trial · Interventional
Status unknownPhase 2Registry dataARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)
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
- Ph 2
ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)
NCT01933529Oct 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.
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.
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)
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.
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
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