A Two-Cohort, Single- and Repeat Dose Study to Examine the Pharmacokinetics, Tolerability, and Safety of Ready to Use Exenatide Once Weekly in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Registration

Registration

NCT00894322

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1; PHASE2

Masking

SINGLE

Status

COMPLETED

Enrollment

65

Start

2009-04

Primary completion

2009-08

Lead sponsor

AstraZeneca

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG:exenatide once weekly; OTHER:Placebo

Results posted

TRUE

Registered primary outcomes

• Area Under the Curve (AUC) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population [Day 1, Week 12]
• Maximum Concentration (Cmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population [Day 1, Week 12]
• Time to Maximum Concentration (Tmax) for Single Dose of 10 mg Exenatide (Cohort 1) in Healthy Participants in the Pharmacokinetic Evaluable Population [Day 1, Week 12]
• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Injection Site TEAEs, Serious Adverse Events (SAEs), Deaths, and Withdrawals Due to AEs in Cohort 1 and Cohort 2 in Intent to Treat (ITT) Population [Day 1 to Week12]
• Number of Participants With Concomitant Medications in Cohort 1 and Cohort 2 in ITT Population [Day 1 to 12 weeks]
• Mean Change From Baseline to End of Study in Sitting Diastolic and Systolic Blood Pressure in Cohorts 1 and 2 in ITT Population [Day 1 to Week 12]
• Mean Change From Baseline to End of Study in Sitting Heart Rate in Cohorts 1 and 2 in ITT Population [Day 1 to Week 12]
• Number of Participants With Hematology and Serum Chemistry Laboratory Values of Potential Clinical Importance in Cohorts 1 and 2 in ITT Population [Day 1 to Week 12]
• Antibody Titers for Participants With Treatment Emergent Positive Antibodies to Exenatide in Participants Who Received Exenatide in Cohorts 1 and 2 [Day 1 to Week 12]
• Area Under the Curve (AUC) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population [Week 10-11; Weeks 10 - 12]
• Average Exenatide Concentration (Cave) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population [Week 10 - Week 11; Week 10 - Week 12]
• Maximum Concentration (Cmax) for 2 mg Exenatide (Cohort 2) in Participants With Diabetes in the Pharmacokinetic Evaluable Population [Week 10, Weeks 10-11, Weeks 10-12]
• Time to Maximum Concentration (Tmax) of 2 mg Exenatide (Cohort 2) in Participants With Diabetes in Pharmacokinetic Evaluable Population [Week 10, Weeks 10-11, Weeks 10-12]