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.
Aims of the study:
The primary purpose of this double blind study is to determine in individuals with
pre-diabetes (IGT, impaired glucose tolerance; or IFG, impaired fasting glucose) and
drug-naïve type 2 diabetes whether ARA 290 reduces disease activity by improving oral
glucose tolerance, and insulin secretion, and thereby improves long-term glucose control.
Secondary objectives are to evaluate the effects of ARA 290 on insulin sensitivity; serum
levels of inflammatory agents, e.g. cytokine levels; serum levels of gluco-regulatory
hormones, such as glucagon-like peptide-1 (GLP-1), glucagon; and safety by registering
reported adverse events, and by monitoring clinical chemistry parameters related to
hematology, kidney function, liver function and lipid levels.
Study Design:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial to
evaluate the effects of ARA 290 on glucose homeostasis in persons with pre-diabetes or
early, dietary treated type 2 diabetes. The trial has two parallel arms with 12 subjects in
each group, and with a 4-week-intervention period. At screening, a baseline investigation
will include a physical examination and the following tests: oral glucose tolerance test
(OGTT), and glycosylated hemoglobin (HbA1c).
The investigational medicinal product (ARA 290, 4.0 mg) or placebo will be self-administered
by a once daily injection s.c. for 28 days. Participating subjects meeting inclusion
criteria, and not fulfilling any exclusion criterion on screening, will be randomized
double-blind within one week following screening 1:1 to either treatment with ARA 290 or
with placebo. Before the first treatment, serum for determination of cytokines, adipokines,
and hormones will be collected. Participants will be investigated further with OGTT, HbA1c
and clinical assessment after 2 weeks and at study end, after 4 weeks. They should also
perform a self-monitoring blood glucose (SMBG) curve once weekly during the treatment
period, e.g., altogether 6 blood glucose tests during one day. Four weeks after the last
dose, patients will return for HbA1c and fasting blood glucose levels.
The primary endpoint of the study is to test whether there is a significant difference
between persons receiving ARA 290 vs. persons receiving placebo in: glucose tolerance,
evaluated by OGTT at baseline, and after 2 and 4 weeks. . The secondary endpoints of the
study include effects of ARA 290 on: insulin sensitivity, evaluated by HOMA-IR (homeostasis
model assessment of insulin resistance); insulin secretion, examined both by measuring the
early insulin response (at 15 and 30 min) in OGTT, and using the HOMA-beta (homeostasis
model assessment of beta cell function); and long-term glucose control, determined as
glycosylated hemoglobin, HbA1c; assessment of serum levels of inflammatory agents, e.g.
cytokine levels; serum levels of gluco-regulatory hormones, such as glucagon-like peptide-1
(GLP-1), and glucagon; and safety by registering reported adverse events, and by monitoring
clinical chemistry parameters related to hematology, kidney function, liver function and
lipid levels.
Patients:
24 patients will be enrolled in one single center; 12 patients will be administered ARA 290
active ingredient product as daily doses for 28 days, and 12 patients will be administered a
placebo as daily doses for 28 days. Individuals with IGT (impaired glucose tolerance), IFG
(impaired fasting glucose) or drug-naïve type 2 diabetes will be included in the study. The
population will consist of individuals of either gender, males aged 40-75 years; women aged
50-75 years and menopausal.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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