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

NCT01933529 | Unknown Phase 2

• 2 other identifiers: APCP-1152012-003207-35
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Type 2; Impaired Glucose Tolerance; Impaired Fasting Glucose

Keywords

diabetes; glucose tolerance; insulin secretion; insulin sensitivity; erythropoietin; inflammation; cytokines

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Insulin sensitivity

  28 days

• Inflammation

  28 days

Other Outcomes (1)

• Clinical chemistry parameter

  28 days

Study Arms (2)

ARA 290

EXPERIMENTAL

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

Drug: ARA 290

Placebo

PLACEBO COMPARATOR

Placebo, injected subcutaneously once every morning during 28 days,

Drug: ARA 290

Interventions

ARA 290 DRUG

ARA 290 is injected s.c. once daily during the study period

ARA 290; Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claes-Göran Östenson: lead
• Araim Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Dept of Endocrinology and Diabetes, Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Diabetes Mellitus; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Hyperinsulinism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claes-Göran Ostenson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 3, 2015

Record last verified: 2015-09

Locations

SE (1)