A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
20 februari 2015 uppdaterad av: AstraZeneca
As exenatide slows the rate at which materials leave the stomach, it is likely to alter the rate of intestinal absorption of oral drugs when administered within a certain timeframe relative to exenatide.
In addition, the residence time within the stomach of other medication may be prolonged and data from this study will help assess the change in residence time in the presence of therapeutic doses of exenatide.
This study will also evaluate the relationship between blood levels of exenatide and parameters measuring rate of stomach emptying.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Nottingham, Storbritannien
- Research Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
25 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subjects with at least 1 year history of type 2 diabetes mellitus.
- Subjects controlled by oral antidiabetic agents or diet and exercise demonstrated by a screening HbA1c ≥7.0% and ≤10.0%.
- Between the body mass index (BMI) of 19 kg/m2 and 40 kg/m2, inclusive.
Exclusion Criteria:
- Within 4 months of the initial dose of study drug, have received a drug that has not received regulatory approval for any indication.
- Persons who have previously completed or withdrawn from this study or any other study investigating exenatide.
- Subjects who are using drugs that significantly affect gastrointestinal motility (including acarbose, metoclopramide, and macrolide antibiotics).
- Subjects who intend to start new concomitant medication during the study, including over-the counter medication, apart from occasional intake of paracetamol or vitamin/mineral supplements. Anti-emetic medication may be permitted at the investigator's discretion, except those that affect gastrointestinal motility.
- Subjects who have used insulin for more than 4 weeks within 3 months prior to screening.
- Blood donation of more than 500 mL in the last 3 months of screening or any blood donation within the last month.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Sequence 1
Exenatide 5 mcg - Exentatide 10 mcg - Placebo
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Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
Period 3 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
Andra namn:
|
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Experimentell: Sequence 2
Exenatide 10 mcg - Placebo - Exenatide 5 mcg
|
Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
Period 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
Andra namn:
Period 1 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
Andra namn:
|
|
Experimentell: Sequence 3
Placebo - Exenatide 5 mcg - Exenatide 10 mcg
|
Period 1 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
Period 2 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
Andra namn:
Period 1 = Subcutaneous injections of placebo in an amount equivalent to exenatide twice daily for 4 days and once in the morning of the 5th day.
Period 2 = Subcutaneous injections of exenatide 5mcg twice daily for 4 days and once in the morning of the 5th day.
Period 3 = Subcutaneous injections of exenatide 5mcg twice daily for 2 days, followed by 2 days of twice daily 10 mcg doses, 10mcg once in the morning of the 5th day.
A washout of at least 2.5 days will occur between each treatment period.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo
Tidsram: up to 12 hours post meal consumption
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A dose of exenatide or placebo is given before the morning meal.
After eating the test meal, images will be recorded at approximately 5 minute intervals from ingestion of the test meal until 3 hours after the meal, then every 10 minutes until 6 hours after the meal.
In cases where significant radioactivity is observed at 6 hours after the meal, additional scintigraphic images may be taken periodically at the discretion of the investigator, until counts approach low values for up to 12 hours after the meal.
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up to 12 hours post meal consumption
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: James Malone, MD, Eli Lilly and Company
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2005
Primärt slutförande (Faktisk)
1 juni 2005
Avslutad studie (Faktisk)
1 juni 2005
Studieregistreringsdatum
Först inskickad
14 augusti 2007
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2007
Första postat (Uppskatta)
16 augusti 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 februari 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 februari 2015
Senast verifierad
1 januari 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H8O-EW-GWAM
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .