- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00672386
A Study of the Safety and Effectiveness of a R256918 in Patients With Type 2 Diabetes
10. juli 2014 oppdatert av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A 12-Week, Double-Blind, Randomized, Placebo-Controlled Study in Type 2 Diabetes Mellitus Subjects to Evaluate the Efficacy, Safety and Tolerability of MTP Inhibitor JNJ-16269110 (R256918)
The purpose of this study is to investigate the effectiveness and safety of 12 weeks of treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin.
The primary measure of effectiveness is the change in concentration of glycated hemoglobin (HbA1c) during treatment.
Glycated hemoglobin is a substance in red blood cells that is formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status.
Additional measures include fasting glucose, and lipid levels, and body weight.
Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
This is a randomized (assigned study drug by chance), double-blind (both the patient and investigator do not know whether patient is assigned to receive study drug or placebo), placebo-controlled study involving patients with Type 2 Diabetes Mellitus who are taking metformin.
Patients are randomized to one of 4 treatment groups and receive study drug (R256918: 5 mg, 10 mg, or 15 mg twice daily) or placebo for a period of 12 weeks.
The study consists of a screening period, a baseline visit, the treatment period of 12 weeks, and a follow-up visit.
During the treatment period, patients visit the center every two weeks.
On each visit, patients come to the clinic after 8 hours fasting.
Effectiveness assessments from a blood sample include levels of fasting hemoglobin type A1c (HbA1c), glucose, cholesterol, triglycerides, insulin, C-peptide, and gastrointestinal hormones.
Patients monitor their fasting blood glucose and record it in a diary.
Insulin sensitivity and beta cell (insulin-producing cells in the pancreas) function are evaluated.
Waist and hip circumference are measured.
Safety evaluations, including incidence of adverse events, clinical laboratory results, vital signs, and electrocardiograms, are performed during the study.
Patients complete a questionnaire related to treatment satisfaction of study medication.
Patients receive dietary counseling and will be instructed to remain on a calorically appropriate diet with a maximum of 30 percent (%) of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus), during the entire study.
Patients continue taking metformin in the same dose and according to the same dosing regimen as before the study.
The overall duration of the study for each patient is approximately 18 weeks.
The study will evaluate the effect of R25691 on glucose-dependent insulin secretion, weight loss and changes in insulin sensitivity and tolerability in type 2 diabetic patients.
Studietype
Intervensjonell
Registrering (Faktiske)
352
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Edegem, Belgia
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Hellerup N/A, Danmark
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Vipperroed, Danmark
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Moscow, Den russiske føderasjonen
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Saratov, Den russiske føderasjonen
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St Petersburg N/A, Den russiske føderasjonen
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St-Petersburg, Den russiske føderasjonen
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Helsinki, Finland
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Hyvinkaa, Finland
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Kuopio, Finland
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Oulu, Finland
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Bangalore, India
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Chennai, India
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Hyderabad, India
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Mumbai, India
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Nagpur, India
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Pune, India
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Breda, Nederland
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Eindhoven, Nederland
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Leiden, Nederland
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Nijmegen, Nederland
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Rotterdam, Nederland
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Velp Gld, Nederland
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Zoetermeer, Nederland
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Oslo, Norge
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Paradis N/A, Norge
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Bialystok, Polen
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Bydgoszcz, Polen
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Elblag, Polen
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Kutno 001, Polen
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Lodz, Polen
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Olsztyn, Polen
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Pruszkow, Polen
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Torun, Polen
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Warszawa, Polen
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Wroclaw, Polen
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Zielona Gora, Polen
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Bangor, Storbritannia
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Belfast, Storbritannia
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Birmingham, Storbritannia
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Cambridge, Storbritannia
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Cardiff, Storbritannia
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Clydebank, Storbritannia
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Dundee, Storbritannia
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Liverpool, Storbritannia
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London, Storbritannia
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Randalstown, Storbritannia
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Reading, Storbritannia
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Salford, Storbritannia
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Göteborg, Sverige
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Härnösand, Sverige
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Linköping, Sverige
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Lund, Sverige
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Stockholm, Sverige
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Ängelholm N/A, Sverige
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Örebro, Sverige
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Berlin Buch, Tyskland
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Dresden, Tyskland
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Düsseldorf, Tyskland
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Hamburg, Tyskland
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Mainz, Tyskland
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Munchen, Tyskland
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Ulm, Tyskland
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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
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- History of Type 2 Diabetes Mellitus and treated with a stable dose of metformin for at least 2 months
- Women must be postmenopausal or surgically incapable of childbearing or if sexually active, be practicing an effective method of birth control
- BMI between 25 and 45 kg/m2
- HbA1c between 7% and 10%, inclusive
- Fasting plasma glucose not exceeding 240mg/dL (13.3mmol/L)
Exclusion Criteria:
- Diabetes other than type 2 diabetes mellitus
- Treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit
- History of intolerance or hypersensitivity to sulfonylurea or sitagliptin
- History of clinically significant gastrointestinal, hepatic or cardiovascular disease
- Active proliferative diabetic retinopathy
- History of diabetic gastroparesis
- concurrent use of systemic corticosteroid
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: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 001
JNJ16269110 5 mg twice daily for 12 weeks
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5 mg twice daily for 12 weeks
10 mg twice daily for 12 weeks
15 mg twice daily for 12 weeks
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
|
Eksperimentell: 002
JNJ16269110 10 mg twice daily for 12 weeks
|
5 mg twice daily for 12 weeks
10 mg twice daily for 12 weeks
15 mg twice daily for 12 weeks
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
|
Eksperimentell: 003
JNJ16269110 15 mg twice daily for 12 weeks
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5 mg twice daily for 12 weeks
10 mg twice daily for 12 weeks
15 mg twice daily for 12 weeks
Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
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Placebo komparator: 004
Placebo twice daily for 12 weeks
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Participants will continue taking metformin at the same dose and according to the same dosing regimen as before the study.
Participants will receive dietary counseling at Screening, Week 4, 8, 12, and will be instructed to remain on a calorically appropriate diet with a maximum of 30% of calories derived from fat (in accordance with local practice guidelines for the treatment of type 2 diabetes mellitus) during the entire study.
twice daily for 12 weeks
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Mean change in HbA1c from baseline to week 12
Tidsramme: baseline, week 4, 6, 8, 10 and 12
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baseline, week 4, 6, 8, 10 and 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Changes in fasting plasma glucose
Tidsramme: every 2 weeks
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every 2 weeks
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Changes in body weight
Tidsramme: every 2 weeks
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every 2 weeks
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Changes in plasma lipids
Tidsramme: baseline, week 6 and 12
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baseline, week 6 and 12
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Changes in systolic and diastolic blood pressure
Tidsramme: every 2 weeks
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every 2 weeks
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Changes in insulin sensitivity and beta cell function (homeostatic model assessment 2 - HOMA-2 and MMTT); Changes in GLP-1 (glucagon-like peptide 1) and PYY (peptide tyrosine tyrozine) levels in the MMTT; Changes in insulin and glucagon
Tidsramme: baseline and Week 12
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baseline and Week 12
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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. desember 2007
Primær fullføring (Faktiske)
1. september 2008
Studiet fullført (Faktiske)
1. september 2008
Datoer for studieregistrering
Først innsendt
2. mai 2008
Først innsendt som oppfylte QC-kriteriene
2. mai 2008
Først lagt ut (Anslag)
6. mai 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. juli 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. juli 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR013051
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