Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, exenatide, Amylin, Lilly
Brief summary
The purpose of this study is the examine the effect of taking exenatide on the blood levels (pharmacokinetics) of orally-administered contraceptives.
Interventions
DRUGethinyl estradiol and levonorgestrel; exenatide
Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pre-menopausal female of child-bearing potential. * Body Mass Index (BMI) between 19 and 35 kg/m\^2, inclusive.
Exclusion criteria
* On implanted contraceptives for 6 months, or injectable contraceptives for 12 months prior to the study. * Evidence of diabetes mellitus. * Participation in a study involving administration of an investigational compound within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax | Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48 | To evaluate the effect of exenatide on the multiple-dose pharmacokinetics of a combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pharmacokinetics profile of exenatide measured by AUC and Cmax | Day 8 and Day 22 of each treatment period hours of sampling: Predose, 0.5, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6,8, 10, 12, 16, 24, 48 | To evaluate the effect of exenatide on the single-dose pharmacokinetics of the combination oral contraceptive when administered one hour prior or 30 minutes after the exenatide dose. |
| Safety and Tolerability assessment by Adverse events, clinical laboratory evaluations, vital signs, ECG blood glucose, body weight, physical examination and exenatide antibodies. | Baseline through Day 84 | Assessment of the safety and tolerability of concomitant administration of exenatide and the combination oral contraceptive by incidence of adverse events, Adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram (ECG), blood glucose, body weight, physical examination and exenatide antibodies. |
Countries
United Kingdom
Outcome results
None listed