Impaired Glucose Tolerance Clinical Trial
Official title:
Effects of ARA 290, a Non-hematopoietic Erythropoietin Analogue, on Glucose Tolerance, Insulin Secretion, Insulin Sensitivity and Long-term Glucose Control in Individuals With Prediabetes and/or Drug-naive Type 2 Diabetes; a Phase II Study.
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.
Status | Active, not recruiting |
Enrollment | 24 |
Est. completion date | December 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Endocrinology and Diabetes, Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Claes-Göran Östenson | Araim Pharmaceuticals, Inc. |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | Yes |
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 | No |
Primary | 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 | No |
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 | No |
Secondary | Inflammation | Assessment of cytokine levels in serum is reduced by ARA290 treatment. | 28 days | No |
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