Diabetes Type 2Phase 2NCT01933529
ARA290 in T2D (Effects of ARA 290, an Erythropoietin Analogue) in Prediabetes and Type 2 Diabetes)
A Phase 2 study testing ARA 290 in people with Diabetes Type 2 and Impaired Glucose Tolerance, run by Claes-Göran Östenson at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Type 2, Impaired Glucose Tolerance, Impaired Fasting Glucose
- What is being tested?
- ARA 290
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Endocrinology and Diabetes, Karolinska University Hospital
Stockholm, 17176
About this study
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.
Read the detailed description
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.
- Being tested
- ARA 290
- Keywords
- diabetes, glucose tolerance, insulin secretion, insulin sensitivity, erythropoietin, inflammation, cytokines
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Diabetes Mellitus, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARA 290Drug
ARA 290 is injected s.c. once daily during the study period
| Study group | Role | What they receive |
|---|---|---|
| ARA 290 | Experimental | ARA 290, 4.0 mg, injected subcutaneously once every morning during 28 days. Receives: Drug: ARA 290 |
| Placebo | Placebo comparator | Placebo, injected subcutaneously once every morning during 28 days, Receives: Drug: ARA 290 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 days
Secondary outcomes (2)
Insulin sensitivity
Insulin sensitivity will be assessed by the HOMA-IR, using fasting glucose and insulin levels at the oral glucose tolerance tests.
Measured: 28 days
Inflammation
Assessment of cytokine levels in serum is reduced by ARA290 treatment.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claes-Göran Östenson
- Sponsor type
- University, hospital or other
- Collaborators
- Araim Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Claes-Göran Östenson, Karolinska Institutet
- Investigators
- Claes-Göran Ostenson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933529
- Sponsor's protocol ID
- APCP-115
- Other IDs
- 2012-003207-35
- Status last verified
- Sep 2015
- First submitted
- 28 Aug 2013
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01933529
- Acronym / sponsor ID
- APCP-115
- Keywords
- diabetes, glucose tolerance, insulin secretion, insulin sensitivity, erythropoietin, inflammation, cytokines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Claes-Göran ÖstensonUniversity, hospital or other
- Collaborators
- Araim Pharmaceuticals, Inc.
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARA 290 | Experimental | Drug: ARA 290ARA 290, 4.0 mg, injected subcutaneously once every morning during 28 days. |
| Placebo | Placebo comparator | Drug: ARA 290Placebo, injected subcutaneously once every morning during 28 days, |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARA 290ARA 290 is injected s.c. once daily during the study period | Drug | ARA 290, Placebo |
Primary outcome
oral glucose tolerance
Time frame: 28 days
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.
Insulin secretion
Time frame: 28 days
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.
2 secondary outcomes
Insulin sensitivity
Time frame: 28 days
Inflammation
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
Related trials for Diabetes Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claes-Göran Ostenson, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARA 290 in people with Diabetes Type 2 and Impaired Glucose Tolerance, run by Claes-Göran Östenson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral glucose tolerance (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2015.