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

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Claes-Göran Östenson
• Collaborator: Araim Pharmaceuticals, Inc.
• Treatments: Epoetin Alfa; Insulin; Insulin, Globin Zinc

Criteria

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.