Type 2 Diabetes MellitusPhase 2NCT01276106
Study of AC-201 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing AC-201, 25mg, AC-201, 50mg and AC-201, 75mg in people with Type 2 Diabetes Mellitus, run by TWi Biotechnology, Inc. at 21 sites in 2 countries.
Trial summary
This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- AC-201, 25mg, AC-201, 50mg and AC-201, 75mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Jan 2011to Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understanding of the study procedures and agreement to participate in the study by giving written informed consent
- Males and females age 20 to 75 years, inclusive
- HbA1c ≥7.5% and ≤10%
- BMI ≤45 kg/m2
- FPG ≤270 mg/dL
- Diagnosis of type 2 diabetes mellitus for ≥6 months
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- On a stable regimen of oral anti-diabetic medications for ≥3 months
- Willingness to maintain stable diet and exercise throughout the study
- Willingness to maintain current doses/regimens of vitamins and dietary supplements throughout the study
- Female patients of childbearing potential and female partners of male patients must be willing to use adequate contraception during the study. All females of childbearing potential must have a negative urine pregnancy test at screening.
Who cannot join
- History of type 1 diabetes and/or history of ketoacidosis
- History of diabetic neuropathy resulting in significant functional impairment and/or requiring active medical or surgical management, including chronic pain syndromes, gastroparesis, skin ulceration, or amputation
- History of long-term therapy with insulin (>30 days) within 1 year of screening;
- Pregnancy or lactation
- Current treatment with any of the following medications within 2 months of screening
- Anti inflammatory drugs, including chronic daily use of systemic corticosteroids (aspirin ≤325 mg per day is allowed)
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- IL-1 modulators: anakinra and rilonacept
- Immunosuppressive drugs: TNF inhibitors and IL-6 monoclonal antibody
- History of severe hypoglycemic episodes within 6 months of screening
- Hypersensitivity to AC-201 or anthraquinone derivatives
- Surgery within 30 days prior to screening
- Serum creatinine >1.5 mg/dL for males or >1.4 mg/dL for females
- Presence of cancer or history of cancer within the past 5 years other than basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix
- Advanced stage heart failure: New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure
- History of unstable angina, myocardial infarction, uncontrolled arrhythmias, cerebrovascular accident, transient ischemic attack, or any revascularization, including percutaneous transluminal coronary angioplasty, within 6 months of screening
- Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg on ≥3 assessments at screening)
- Known to be infected with human immunodeficiency virus (HIV)
- History of acquired immune deficiency syndrome
- History of TB, active TB (pulmonary, extra-pulmonary, or military), or a positive test for TB confirmed by a PA chest x-ray within 6 months prior to screening
- History of acute infection with Epstein-Barr Virus (EBV), cytomegalovirus (CMV), or hepatitis C virus (HCV) within 4 weeks prior to screening
- History of chronic active (not latent) hepatitis B virus, HCV, or CMV infection;
- History of drug or alcohol abuse
- Aspartate aminotransferase >3 × the upper limit of normal (ULN) or alanine aminotransferase >3 × ULN at screening
- Total bilirubin >1.5 × ULN at screening
- Triglycerides >500 mg/dL at screening
- Poor mental function or any other reason to expect patient difficulty in complying with the study requirements
- Acute infections that may affect blood glucose control within 4 weeks prior to screening
- Known bilateral renal artery stenosis, patient with a solitary kidney, or a post renal transplant
- History of autoimmune disease or collagen vascular disease
- History of hyperthyroidism or hypocorticism
- Participation in any AC-201 studies within 1 year prior to screening
- Participation in an investigational drug study within 30 days prior to screening
- Any other serious diseases which, in the opinion of the investigator, might pose a risk to the patient or make participation not in the patient's best interest.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States13 sites
Chicago Clinical Research Institute, Inc.
Chicago, Illinois
Catalina Research Institute, LLC
Chino, California
Sterling Research Group, Ltd
Cincinnati, Ohio
Clinical Research of South Florida
Coral Gables, Florida
Clinical Investigation Specialists, Inc.
Gurnee, Illinois
Midwest Institute for Clinical Research, Inc.
Indianapolis, Indiana
Jacksonville Impotence Treatment Center
Jacksonville, Florida
PriMed Clinical Research
Kettering, Ohio
National Research Institute
Los Angeles, California
L-MARC Research Center
Louisville, Kentucky
New Orleans Center for Clinical Research
New Orleans, Louisiana
Rainier Clinical Research Center, Inc.
Renton, Washington
National Clinical Research-Richmond, Inc.
Richmond, Virginia
Taiwan8 sites
Changhua Christian Hospital
Changhua
Cheng Ching General Hospital
Taichung
Chung Shan Medical University Hospital
Taichung
Kuang Tien General Hospital
Taichung
Cardinal Tien Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Medical University-Shuang Ho Hospital
Taipei
Tri-Service General Hospital
Taipei
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of AC-201 in Patients With Type 2 Diabetes Mellitus
This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- AC-201, 25mg, AC-201, 50mg, AC-201, 75mg, Placebo
- Keywords
- AC-201, Interleukin 1 inhibitor
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-201, 25mgDrug
Capsule, 25mg BID
AC-201, 50mgDrug
Capsule, 50mg BID
AC-201, 75mgDrug
Capsule, 75mg BID
PlaceboDrug
Placebo BID
| Study group | Role | What they receive |
|---|---|---|
| AC-201, 25mg | Experimental | 25mg BID for 24 weeks Receives: Drug: AC-201, 25mg |
| AC-201, 50mg | Experimental | 50mg BID for 24 weeks Receives: Drug: AC-201, 50mg |
| AC-201, 75mg | Experimental | 75mg BID for 24 weeks Receives: Drug: AC-201, 75mg |
| Placebo | Placebo comparator | Placebo BID for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Baseline
For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p<0.05.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies 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, Care provider, Investigator
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- TWi Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276106
- Sponsor's protocol ID
- AC-201-DM-001
- Status last verified
- Apr 2018
- First submitted
- 11 Jan 2011
- Last updated
- 22 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase II Study of AC-201 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01276106
- Acronym / sponsor ID
- AC-201-DM-001
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- AC-201, Interleukin 1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- TWi Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 18 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AC-201, 25mg | Experimental | Drug: AC-201, 25mg25mg BID for 24 weeks |
| AC-201, 50mg | Experimental | Drug: AC-201, 50mg50mg BID for 24 weeks |
| AC-201, 75mg | Experimental | Drug: AC-201, 75mg75mg BID for 24 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo BID for 24 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understanding of the study procedures and agreement to participate in the study by giving written informed consent
- Males and females age 20 to 75 years, inclusive
- HbA1c ≥7.5% and ≤10%
- BMI ≤45 kg/m2
- FPG ≤270 mg/dL
Key exclusion criteria (33 listed)
- History of type 1 diabetes and/or history of ketoacidosis
- History of diabetic neuropathy resulting in significant functional impairment and/or requiring active medical or surgical management, including chronic pain syndromes, gastroparesis, skin ulceration, or amputation
- History of long-term therapy with insulin (>30 days) within 1 year of screening;
- Pregnancy or lactation
- Current treatment with any of the following medications within 2 months of screening
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 |
|---|---|---|
| AC-201, 25mgCapsule, 25mg BID | Drug | AC-201, 25mg |
| AC-201, 50mgCapsule, 50mg BID | Drug | AC-201, 50mg |
| AC-201, 75mgCapsule, 75mg BID | Drug | AC-201, 75mg |
| PlaceboPlacebo BID | Drug | Placebo |
Primary outcome
Change in HbA1c From Baseline
Time frame: 24 weeks
For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p<0.05.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AC-201, 25mg, AC-201, 50mg and AC-201, 75mg in people with Type 2 Diabetes Mellitus, run by TWi Biotechnology, Inc. at 21 sites in 2 countries.
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 10 inclusion and 33 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: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Taiwan. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in HbA1c From Baseline (time frame: 24 weeks). 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 22 May 2018.