The effect of treatment interruption on safety and efficacy of exenatide in patients with Type 2 Diabetes. - GWBO
- Conditions
- Type 2 Diabetes
- Registration Number
- EUCTR2006-006149-15-HU
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1. Patients with Type 2 diabetes
2. Previous exposure to exenatide for at least 3 months in previous studies GWAO , GWAP or GWAT (114).
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
1. Are Lilly or Amylin employees.
2. 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.
3. Have previously completed or withdrawn from this study.
4. 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 3 months prior to screening.
•Do not agree to continue to use a reliable method of birth control during the study, as determined by the investigator.
5. Has poorly controlled blood pressure (>=180 mm Hg, systolic value; >=110 mm Hg, diastolic value).
6. Have a known allergy to exenatide.
7. Have taken marketed exenatide during the interim period between studies GWAO, GWAP, or GWAT and the current study.
8. 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.
9. Have a history of renal transplantation or are currently receiving renal dialysis or have an estimated creatinine clearance of <50 mL/min.
10. Have obvious clinical signs or symptoms of liver disease, chronic hepatitis, or (ALT/SGPT) >2.5 times the upper limit of the reference range.
11. Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar otc medications) within 3 months of screening.
12. Are currently treated with any of the following excluded medications:
•Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride and chronic macrolide antibiotics.
13. 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.
14. Have had an organ transplant.
15. 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: To 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, in patients previously exposed to exenatide in clinical trials H80-MC-GWAO and H80-MC-GWAP or GWAT (114).;Secondary Objective: To evaluate the impact of anti-exenatide antibodies on patients' safety and efficacy as assessed by incidence of adverse events and change in HbA1c.;Primary end point(s): Treatment-emergent anti-exenatide antibodies titre and relationship to adverse events particularly allergy and hypersensitivity.
- Secondary Outcome Measures
Name Time Method