Glucose IntoleranceNCT01285232
The Effect of Anakinra on Insulin Secretion
A study testing Anakinra in people with Glucose Intolerance and Impaired Insulin Secretion, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Impaired Insulin Secretion, Diabetes Mellitus Type 2
- What is being tested?
- Anakinra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
- BMI >25 kg/m2
- Age 40-70 years
Who cannot join
- Known diabetes mellitus
- Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
- Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
- Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
- Signs of current infection (fever, C-reactive protein >30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
- A history of recurrent infections
Show all 13Show fewer
- Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
- Renal disease defined as MDRD < 60 ml/min/1.73m2
- Neutropenia < 2x 109/L
- Inability to understand the nature and extent of the trial and the procedures required.
- Any medical condition that might interfere with the current study protocol
- Participation in a drug trial within 60 days prior to the first dose
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
Official title: The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction
Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.
Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.
- Being tested
- Anakinra
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnakinraDrug
Also called Kineret, Interleukin1-receptor antagonist
150 mg sc once daily during four weeks
| Study group | Role | What they receive |
|---|---|---|
| Anakinra | Experimental | Anakinra 150 mg/day during four weeks Receives: Drug: Anakinra |
| Placebo | Placebo comparator | Placebo during four weeks Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .
Measured: after 4 weeks of treatment with anakinra
Secondary outcomes (2)
To determine the effect on anakinra on insulin sensitivity.
Oral glucose tolerance test
Measured: after 4 week treatment of anakinra
Effects of anakinra on fat cell morphology and gene expression
Fatbiopsy
Measured: after 4 weeks of treatment with anakinra
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C.J. Tack, MD, PhD, Prof. of Diabetology, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285232
- Sponsor's protocol ID
- Anakinra1
- Status last verified
- Sep 2010
- First submitted
- 8 Nov 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction
- ClinicalTrials.gov ID
- NCT01285232
- Acronym / sponsor ID
- Anakinra1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Jan 2011 (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.
Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.
Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anakinra | Experimental | Drug: AnakinraAnakinra 150 mg/day during four weeks |
| Placebo | Placebo comparator | Drug: AnakinraPlacebo during four weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
- BMI >25 kg/m2
- Age 40-70 years
Key exclusion criteria (13 listed)
- Known diabetes mellitus
- Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
- Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
- Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
- Signs of current infection (fever, C-reactive protein >30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
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 |
|---|---|---|
| AnakinraAlso: Kineret, Interleukin1-receptor antagonist150 mg sc once daily during four weeks | Drug | Anakinra, Placebo |
Primary outcome
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .
Time frame: after 4 weeks of treatment with anakinra
2 secondary outcomes
To determine the effect on anakinra on insulin sensitivity.
Time frame: after 4 week treatment of anakinra
Effects of anakinra on fat cell morphology and gene expression
Time frame: after 4 weeks of treatment with anakinra
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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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.
C.J. Tack, MD, PhD, Prof. of Diabetology principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anakinra in people with Glucose Intolerance and Impaired Insulin Secretion, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 13 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 26 Mar 2012. 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 Netherlands. 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.
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?
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps . (time frame: after 4 weeks of treatment with anakinra). 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 26 Mar 2012.