A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00517283
First received: August 14, 2007
Last updated: September 18, 2013
Last verified: September 2013

August 14, 2007
September 18, 2013
January 2005
June 2005   (final data collection date for primary outcome measure)
To detect the mean difference in half gastric emptying time for a solid meal between any treatment and placebo [ Time Frame: up to 12 hours post meal consumption ] [ Designated as safety issue: No ]
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.
To evaluate the gastric emptying of a test meal by scintigraphy after subcutaneous (sc) administration of multiple doses of exenatide or placebo in subjects with type 2 diabetes. [ Time Frame: 21 days ]
Complete list of historical versions of study NCT00517283 on ClinicalTrials.gov Archive Site
Not Provided
  • To explore the relationship between plasma exenatide exposure and measures of gastric emptying following sc administration of exenatide. [ Time Frame: 21 days ]
  • To further explore the safety and tolerability of exenatide administered sc to subjects with type 2 diabetes. [ Time Frame: 21 days ]
  • To explore a possible effect of sc administration of exenatide on gastric emptying in type 2 diabetic subjects with autonomic neuropathy. [ Time Frame: 21 days ]
Not Provided
Not Provided
 
A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes
A Study by Scintigraphy to Evaluate the Effect of Exenatide on Gastric Emptying in Subjects With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide and placebo
    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.
    Other Names:
    • Byetta
    • AC2993
    • synthetic exendin-4
  • Drug: Exenatide and placebo
    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.
    Other Names:
    • Byetta
    • AC2993
    • synthetic exendin-4
  • Drug: Exenatide and placebo
    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.
    Other Names:
    • Byetta
    • AC2993
    • synthetic exendin-4
  • Experimental: Sequence 1
    Exenatide 5 mcg - Exentatide 10 mcg - Placebo
    Intervention: Drug: exenatide and placebo
  • Experimental: Sequence 2
    Exenatide 10 mcg - Placebo - Exenatide 5 mcg
    Intervention: Drug: Exenatide and placebo
  • Experimental: Sequence 3
    Placebo - Exenatide 5 mcg - Exenatide 10 mcg
    Intervention: Drug: Exenatide and placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
June 2005
June 2005   (final data collection date for primary outcome measure)

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.
Both
25 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00517283
H8O-EW-GWAM
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP