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

• Conditions: Type 2 diabetes; MedDRA version: 9.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitus

• Registration Number: EUCTR2006-006149-15-IT
• Lead Sponsor: Eli lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 53

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4.Have previously completed or withdrawn from this study.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.

11.Have obvious clinical signs or symptoms of liver disease, chronic hepatitis, or alanine aminotransaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.5 times the upper limit of the reference range.

12.Used drugs for weight loss (for example, Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], or similar over-the-counter medications) within 3 months of screening.

13.Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan (metoclopramide), Propulsid (cisapride), and chronic macrolide antibiotics.

14.Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.

15.Have had an organ transplant.

16.Use insulin with daily dosage exceeding 1 U/kg.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the anti-exenatide-antibody response to exenatide re-exposure as measured by anti-exenatide antibodies and incidence of treatment-emergent allergy and hypersensitivity reactions following a period of treatment interruption;Secondary Objective: Evaluate the impact of anti-exenatide antibodies on patient's safety and efficay, as assessed by: incidence of the adverse events and change in hemoglobin A1c (HbA1c);Primary end point(s): Changes in HbA1c ang changes in body weight.