A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension

AstraZeneca

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Placebo; Drug: exenatide once weekly

Study type: Interventional

Funder types: Industry

Identifiers

NCT00894322

BCB110

Details and patient eligibility

About

This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.

Enrollment: 65 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cohort 1:

• Is 19 to 65 years old
• Has a body mass index (BMI) of 23 kg/m2 to 35 kg/m2, inclusive, at study start

Cohort 2:

• Is 19 to 75 years old

• Has been diagnosed with type 2 diabetes mellitus

• Has HbA1c of 7.1% to 10.0%, inclusive, at study start

• Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at study start

• Has been treated with diet and exercise alone or with a stable regimen of metformin, a TZD, or a combination of metformin and a TZD, for a minimum of 2 months prior to study start

• Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:

  • Hormone replacement therapy (female subjects)
  • Oral contraceptives (female subjects)
  • Antihypertensive agents
  • Lipid-lowering agents
  • Thyroid replacement therapy
  • Antidepressant agents

Exclusion criteria

Cohort 1:

• Has a personal history of diabetes mellitus (including impaired glucose tolerance, impaired fasting glucose, or gestational diabetes)
• Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
• Has ever been exposed to exenatide (BYETTA, exenatide once weekly, or any other formulation of exenatide) or any GLP 1 analog

Cohort 2:

• Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start

• Has ever been exposed to exenatide (BYETTA, exenatide once weekly, or any other formulation of exenatide) or any GLP 1 analog

• Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:

  • Any DPP-4 inhibitor or sulfonylurea (SU) within 3 months prior to study start
  • Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start
  • Insulin within 2 weeks prior to study start or for more than 1 week within 3 months prior to study start
  • Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
  • Prescription or over-the-counter weight loss medications within 3 months prior to study start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups, including a placebo group

Cohort 1: Healthy Participants

Experimental group

Description:

A single 10-mg dose of exenatide once weekly suspension given to healthy participants via 3 subcutaneous (SC) injections at Day 1.

Treatment:

Drug: exenatide once weekly

Drug: exenatide once weekly

Cohort 2: Diabetes Participants

Experimental group

Description:

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks.

Treatment:

Drug: exenatide once weekly

Drug: exenatide once weekly

Cohort 2: Diabetes Participants Placebo

Placebo Comparator group

Description:

On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks.

Treatment:

Other: Placebo