Type 2 diabetes mellitus
Conditions
Interventions
Product Name: Exenatide
Product Code: AC2993, LY2148568
Pharmaceutical Form: Solution for injection
CAS Number: 141732-76-5
Current Spon
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the study (Visit 9 of Study H8O-MC-GWAA or Visit 11 of Study H8O-MC-GWAD). [2] Patients must have given informed consent for Study H8O-MC-GWAN in accordance with local regulations. Are the trial subjects under 18? 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
Exclusion criteria: 1. Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD. 2. Female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause): · intend to become pregnant during the study, or · refuse to use a reliable method of birth control during the study, as determined by the investigator. 3. Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that renders them unable to understand the nature, scope, and possible consequences of the study or precludes them from following and completing the protocol, in the opinion of the investigator. 4. Patients fail to satisfy the investigator of suitability to participate for any other reason. 5. Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry. 6. Patients are investigative site personnel directly affiliated with the study, or are immediate family of investigative site personnel directly affiliated with the study. 7. Patients are employed by Lilly or Amylin. Immediate family of Lilly or Amylin employees may participate in Lilly-sponsored or Lilly-managed clinical trials, but are not permitted to participate at a Lilly facility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome measure of this study will be the the summary of adverse events. ;Main Objective: The objective of this study is to assess the long term safety of twice daily exenatide treatment, as defined by the occurrence of adverse events, in patients with type 2 diabetes mellitus.;Secondary Objective: None | — |
Countries
Finland, Italy, United Kingdom
Outcome results
None listed