- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01843127
A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.
28. marts 2014 opdateret af: Gilead Sciences
A Phase 1, Randomized, Single-blind, Placebo-controlled, Multiple-dose, Two-sequence, Cross-over Study to Evaluate the Effect of Ranolazine on Glucagon Secretion in Subjects With Type 2 Diabetes Mellitus, Followed by An Open-label, Single Dose, Exenatide Active-control Period
To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes mellitus (T2DM).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Chula Vista, California, Forenede Stater, 91911
- Profil Institute for Clinical Research, Inc.
-
-
Florida
-
Miami, Florida, Forenede Stater, 33126
- SeaView Research, Inc
-
Orlando, Florida, Forenede Stater, 32804
- Translational Research Institute-Florida Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Males and females, 18 to 65 years old, inclusive
- Documented history of T2DM for ≥5 years
- Body mass index (BMI) 20.0 to 40.0 kg/m2, inclusive, at Screening
- Stable treatment (≥ 12 weeks) with metformin alone, a sulfonylurea alone, a meglitinide alone, or a combination of metformin with either a sulfonylurea or a meglitinide
- HbA1c ≥ 7.0% and ≤ 10.5%, inclusive, at Screening
- Fasting glucose within specific ranges, at Screening and after 14 +/-2 days of wash-out from prior oral anti-diabetic agents
- Fasting serum C-peptide ≥0.8 ng/mL, at Screening
- Estimated glomerular filtration rate (eGFR)≥60 mL/min/1.73 m2
- Ability and willingness to comply with all study procedures during the course of the study, including washout from oral anti-diabetic (OAD) agents approximately 2 weeks prior to Day -2 admission
- Females of childbearing potential must have a negative pregnancy test at Screening and on Day -2 admission and must agree to use highly effective contraception methods from Screening throughout study participation and for 14 days following the last dose of study drug.
Exclusion Criteria:
- History of type 1 diabetes mellitus or secondary forms of diabetes
- History of acute diabetes complications
- Recent or significant heart conditions
- Uncontrolled hypertension
- QTc interval > 500 msec by ECG at Screening or on Day -2 admission, a personal or family history of QTc prolongation, congenital long QT syndrome, or use of drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
- History of severe GI disease (e.g., gastroparesis)
- History of pancreatitis (acute or chronic)
- Current consumption of > 14 alcoholic drinks per week, or more than 4 alcoholic drinks on any one day
- Current regular use of tobacco- or nicotine-containing products in excess of 10 cigarettes per day or equivalent
- History of substance abuse within 12 months prior to Screening
- Significant hepatic disease, including, but not limited to, chronic active hepatitis and liver cirrhosis (Child-Pugh Class A, B, or C)
- History of malignancy within 5 years prior to Screening
- Significant thyroid disease
- Treatment with selected medications, as indicated in the protocol
- Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine or its excipients
- Known hypersensitivity or intolerance to GLP-1 mimetics
- Known hypersensitivity or intolerance to acetaminophen
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 X upper limit of normal (ULN)
- Total Bilirubin (TB) > 2 mg/dL
- Hemoglobin < 12 g/dL (for males) or < 11 g/dL (for females)
- Positive for hepatitis B surface antigen
- Positive for anti-hepatitis C virus antibody
- Positive for human immunodeficiency virus-1 (HIV-1) antibody
- Positive urine drug screen
- Positive alcohol test
- Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 500 mL of blood during the 6 weeks prior to Screening
- Females who are pregnant or breastfeeding
- Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol, or would compromise the quality of the clinical study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Placebo, Ranolazine, Exenatide
|
|
|
Aktiv komparator: Ranolazine, Placebo, Exenatide
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Area under the concentration-time curve (AUC) of plasma glucagon during the standard meal test (SMT)
Tidsramme: Days 5, 10, and 14
|
Days 5, 10, and 14
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plasma glucose, serum insulin, and serum C-peptide AUCs during the SMT
Tidsramme: Days 5, 10, and 14
|
Days 5, 10, and 14
|
|
Collapse under Acetaminophen PK
Tidsramme: Days 5 and 10
|
Days 5 and 10
|
|
Area under the plasma acetaminophen concentration-time curve from time 0 to 240 min (AUC0-240 min)
Tidsramme: Days 5 and 10
|
Days 5 and 10
|
|
Collapse all under ranolazine pharmacokinetics (PK)
Tidsramme: Days 5 and 10
|
Days 5 and 10
|
|
Trough plasma ranolazine concentrations (Ctrough)
Tidsramme: Days 5 and 10
|
Days 5 and 10
|
|
Average plasma ranolazine concentration during a dosing interval at steady state (Css,ave)
Tidsramme: Days 5 and 10
|
Days 5 and 10
|
|
Area under the plasma ranolazine concentration-time curve over dosing interval (AUCtau)
Tidsramme: Days 5 and 10
|
Days 5 and 10
|
|
Apparent elimination half-life (t1/2) of ranolazine
Tidsramme: Days 5 and 10
|
Days 5 and 10
|
|
Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments.
Tidsramme: From Screening to 7 days after the final dose
|
From Screening to 7 days after the final dose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2013
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. september 2013
Datoer for studieregistrering
Først indsendt
17. april 2013
Først indsendt, der opfyldte QC-kriterier
29. april 2013
Først opslået (Skøn)
30. april 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Membrantransportmodulatorer
- Natriumkanalblokkere
- Midler mod fedme
- Inkretiner
- Exenatid
- Ranolazin
Andre undersøgelses-id-numre
- GS-US-259-0165
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .