- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02150824
Safety and Tolerability, Efficacy, Pharmacokinetic and Pharmacodynamic Study of Three Doses of BI 187004 Over 28 Days in Patients With Type 2 Diabetes Mellitus With and Without Metformin
12. august 2015 oppdatert av: Boehringer Ingelheim
A Randomized, Double-blind, Placebo-controlled, Parallel Groups Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of Three BI 187004 Doses Given Once Daily as Mono-therapy and of the Highest BI 187004 Dose Given Once Daily as Add on Treatment to Metformin Over 28 Days in Patients With Type 2 Diabetes Mellitus
Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days.
Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
103
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Berlin, Tyskland
- 1307.4.49003 Boehringer Ingelheim Investigational Site
-
Mainz, Tyskland
- 1307.4.49002 Boehringer Ingelheim Investigational Site
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Neuss, Tyskland
- 1307.4.49001 Boehringer Ingelheim Investigational Site
-
-
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 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion criteria:
- Male or postmenopausal or hysterectomised female patients with diagnosis of Type 2 Diabetes Mellitus (T2DM) before informed consent
To be eligible for Arm 1
- Oral antidiabetic mono-therapy for the last 12 weeks prior to Informed Consent AND Glycosylated haemoglobin (HbA1c) >= 6.5% and <= 8.5% at Visit 1a
- Therapy-naïve patients or no antidiabetic treatment within 4 weeks prior to Informed Consent AND HbA1c >= 7.0% and <= 9.5% at Visit 1a.
To be eligible for Arm 2:
a. Antidiabetic treatment with metformin with an unchanged daily dose for 12 weeks prior to Informed Consent AND patient´s willingness to keep this therapy stable during the course of the trial AND HbA1c >= 7.0% and <= 9.5% at Visit 1a
- Age >=18 and <=80 years for female hysterectomised and male patients at Visit 1a
- Age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at Visit 1a
- Body mass index (BMI) >= 28 and <= 40 kg/m2 at Visit 1a
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion criteria:
- Treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a.
- Fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (Visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug
- Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment
- Any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension
- Medical history of cancer or treatment for cancer in the last five years prior to the Visit 1a.
- History of Cushing syndrome, Addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome
- Treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug.
- Treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance.
- Use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication.
- Surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial
- Any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. Smoking habits interfering with hospitalization. Patients not willing to abstain from alcoholic beverages during inpatient visits
- Male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
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: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: BI 187004 low dose mono QD
patient to receive one tablet containing low dose of BI 187004 or matching placebo
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
Eksperimentell: BI 187004 medium dose mono QD
patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
Eksperimentell: BI 187004 high dose mono QD
patient to receive one tablet containing high dose of BI 187004 or matching placebo
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
Eksperimentell: BI 187004 high dose QD add on
patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose
|
BI 187004 high dose matching placebo once daily
BI 187004 medium dose matching placebo once daily
BI 187004 high dose matching placebo once daily add on to background metformin
BI 187004 high dose once daily add on to background metformin
BI 187004 low dose matching placebo once daily
BI 187004 medium dose once daily
BI 187004 low dose once daily
BI 187004 high dose once daily
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The percentage of patients with drug- related adverse events
Tidsramme: 6 weeks
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment
Tidsramme: 4 weeks
|
4 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. juli 2014
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. august 2015
Datoer for studieregistrering
Først innsendt
28. mai 2014
Først innsendt som oppfylte QC-kriteriene
29. mai 2014
Først lagt ut (Anslag)
30. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. august 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1307.4
- 2013-003646-16 (EudraCT-nummer: EudraCT)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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