An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients with Type 2 Diabetes - ND

Eli lilly and Company0 sites53 target enrollmentAugust 6, 2007

ConditionsType 2 diabetes MedDRA version: 9.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 diabetes
Sponsor: Eli lilly and Company
Enrollment: 53
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 6, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Eli lilly and Company

Eligibility Criteria

Inclusion Criteria

•1\.Presents with type 2 diabetes based on the disease diagnostic criteria
•2\.Have been exposed to exenatide for at least 3 months in previous Studies GWAO, GWAP, or GWAT.
•3\.Have interrupted their exenatide treatment for a period of 2 months to 2\.5 years.
•4\.HbA1c of ≤10\.5%.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•1\.Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
•2\.Are Lilly or Amylin employees.
•3\.Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
•4\.Have previously completed or withdrawn from this study.
•5\.Exclusion criterion \[8] applies to females of child\-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) only: Are breastfeeding, Test positive for pregnancy at the time of enrollment based on a blood serum pregnancy test, Intend to become pregnant during the study, Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening, Do not agree to continue to use a reliable method of birth control (see above) during the study, as determined by the investigator.
•6\.Has poorly controlled blood pressure (≥ 180 mm Hg, systolic value; ≥110 mm Hg, diastolic value).
•7\.Have a known allergy to exenatide.
•8\.Have taken marketed exenatide during the interim period between studies GWAO, GWAP, or GWAT and the current study.
•9\.Have a clinically significant coronary artery disease history or presence of Class III or IV cardiac disease, coronary artery bypass surgery, or angioplasty within the year prior to inclusion in the study; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
•10\.Have a history of renal transplantation or are currently receiving renal dialysis or have an estimated creatinine clearance of \<50 mL/min, as estimated by the Cockcroft\-Gault equation.