For the complementary visits
Conditions
Interventions
Product Name: ARA 290
Product Code: ARA 290
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Innate repair activator peptide
Other descriptive name: ARA 290
Concentration un
Sponsors
Karolinska University Hospital Solna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Informed consent obtained prior to any trial-related activities b. 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; IGT = 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. c. Age 40-75 years, of both sexes, however women only above 50 year and in menopause. d. BMI (body mass index) = 35 kg/m2. e. Fasting P-glucose = 9 mmol/l. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Anticipated change in concomitant medication that may interfere with blood glucose homeostasis, such as systemic glucocorticoids, non-selective beta blockers and anabolic steroids. b. Anti-diabetic (anti-hyperglycemic) medication of any kind. c. Impaired renal function, defined as S-creatinine = 125 umol/l for men and = 115 umol/l for women. d. Impaired hepatic function defined as plasma alanin aminotransferase (P-ALT) = three times the upper reference limit. e. Cardiac disease defined as unstable angina pectoris, or myocardial infarction within the last 6 months, or congestive heart failure NYHA class III or IV. f. Cerebral stroke within the last 6 months. g. Uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg). h. Cancer, diagnosed and/or treated within the last 5 years. i. Females of childbearing potential. j. Known or suspected abuse of alcohol or narcotic drugs. k. Patients should not have received a vaccination or immunization within the month peior screening. l. The use of Anti-TNF therapy or other biological anti-inflammatory agents administered within 3 months to screening is not allowed. m. The use of erythropoiesis stimulating agents within the two months prior to screening or during the trial is not allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the already approved study was to assess the effects of ARA 290, administered as a daily s.c. injection over 4 weeks, on oral glucose tolerance evaluated by OGTT in individuals with prediabetes (impaired fasting glucose, impaired glucose tolerance) and/or diet-treated type 2 diabetes. The objective of the 2 complementary visits is to observe the effect of one single dose of ARA 290 on the insulin and blood sugar levels when 300 mg/kg glucose is injected intavenously, compared to placebo.;Secondary Objective: Approved study: To assess the effects of ARA 290 on: a) insulin sensitivity, evaluated by HOMA-IR modeling b) insulin secretion and long-term glucose-tolerance c) anti-inflammatory factors, cytokines etc., and d) other hormones, e.g. glucagon-like peptide-1 (GLP-1), glucagon. e) safety by registering reported AE and regular monitoring of vitale signs, hematology and Clinical chemistry For the complementary visits: No additional secondary objectives.;Primary end point(s): To test whether there is a significant difference between persons receiving ARA290 vs.persons receiving placebo in glucose tolerance, evaluated by OGTT at baseline, and after 2 and 4 weeks. For the complementary visits: To test the effect of one single injection of ARA290 on insulin and blood sugar levels compared to one single injection of placebo. ;Timepoint(s) of evaluation of this end point: Pre-treatment, at two weeks and at the end of four weeks of treatment. For the complementary visits: 2, 5, 7, 10, 20, 30, 60 and 120 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effects of ARA290 on: a. Insulin sensitivity, evaluated by HOMA-IR (13). b. Insulin secretion, examined both by measuring the early insulin response in OGTT and using HOMA-beta assessment. c. Long-term glucose Control, determined as glycosylated hemoglobin, HbA1c. d. Serum levels of inflammatory agents, e.g. cytokine levels. e. Serum levels of glucoregulatory hormones, such as glucagon-like peptide-1 (GLP-1), glucagon, and urinary levels of cortisol. f. Safety by registering reported adverse events, and by monitoring clinical chemistry parameters related to hematology, kidney function, liver function and lipid levels. For the complementary visits: No additional secondary endpoints;Timepoint(s) of evaluation of this end point: Pre-treatment, at 2 weeks and at the end of four weeks of treatment. N/A for the complementary visits | — |
Countries
Sweden
Contacts
Public ContactPrincipal Investigator
Karolinska University Hospital Solna
Outcome results
None listed