| Trial ID: | L2993 |
| Source ID: | NCT01933529
|
| Associated Drug: |
Ara 290
|
| Title: |
ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 2|Impaired Glucose Tolerance|Impaired Fasting Glucose
|
| Interventions: |
DRUG: ARA 290
|
| Outcome Measures: |
Primary: oral glucose tolerance, 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., 28 days|Insulin secretion, 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., 28 days | Secondary: Insulin sensitivity, Insulin sensitivity will be assessed by the HOMA-IR, using fasting glucose and insulin levels at the oral glucose tolerance tests., 28 days|Inflammation, Assessment of cytokine levels in serum is reduced by ARA290 treatment., 28 days | Other: Clinical chemistry parameter, Determination of parameters related to hematology, kidney and liver function as well as lipids at baseline and after 28 days of treatment., 28 days
|
| Sponsor/Collaborators: |
Sponsor: Claes-Göran Östenson | Collaborators: Araim Pharmaceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-10
|
| Completion Date: |
2015-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-09-03
|
| Locations: |
Dept of Endocrinology and Diabetes, Karolinska University Hospital, Stockholm, 17176, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT01933529
|
