Study of AC-201 in Patients With Type 2 Diabetes Mellitus
24. april 2018 oppdatert av: TWi Biotechnology, Inc.
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
259
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Chino, California, Forente stater
- Catalina Research Institute, LLC
-
Los Angeles, California, Forente stater
- National Research Institute
-
-
Florida
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Coral Gables, Florida, Forente stater
- Clinical Research of South Florida
-
Jacksonville, Florida, Forente stater
- Jacksonville Impotence Treatment Center
-
-
Illinois
-
Chicago, Illinois, Forente stater
- Chicago Clinical Research Institute, Inc.
-
Gurnee, Illinois, Forente stater
- Clinical Investigation Specialists, Inc.
-
-
Indiana
-
Indianapolis, Indiana, Forente stater
- Midwest Institute for Clinical Research, Inc.
-
-
Kentucky
-
Louisville, Kentucky, Forente stater
- L-MARC Research Center
-
-
Louisiana
-
New Orleans, Louisiana, Forente stater
- New Orleans Center for Clinical Research
-
-
Ohio
-
Cincinnati, Ohio, Forente stater
- Sterling Research Group, Ltd
-
Kettering, Ohio, Forente stater
- PriMED Clinical Research
-
-
Virginia
-
Richmond, Virginia, Forente stater
- National Clinical Research-Richmond, Inc.
-
-
Washington
-
Renton, Washington, Forente stater
- Rainier Clinical Research Center, Inc.
-
-
-
-
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Changhua, Taiwan
- Changhua Christian Hospital
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Taichung, Taiwan
- Cheng Ching General Hospital
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Taichung, Taiwan
- Chung Shan Medical University Hospital
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Taichung, Taiwan
- Kuang Tien General Hospital
-
Taipei, Taiwan
- Tri-Service General Hospital
-
Taipei, Taiwan
- Taipei Medical University Hospital
-
Taipei, Taiwan
- Taipei Medical University-Shuang Ho Hospital
-
Taipei, Taiwan
- Cardinal Tien Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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)
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: AC-201, 25mg
25mg BID for 24 weeks
|
Capsule, 25mg BID
|
|
Eksperimentell: AC-201, 50mg
50mg BID for 24 weeks
|
Capsule, 50mg BID
|
|
Eksperimentell: AC-201, 75mg
75mg BID for 24 weeks
|
Capsule, 75mg BID
|
|
Placebo komparator: Placebo
Placebo BID for 24 weeks
|
Placebo BID
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in HbA1c From Baseline
Tidsramme: 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.
|
24 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. februar 2012
Studiet fullført (Faktiske)
1. mars 2012
Datoer for studieregistrering
Først innsendt
11. januar 2011
Først innsendt som oppfylte QC-kriteriene
12. januar 2011
Først lagt ut (Anslag)
13. januar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AC-201-DM-001
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