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Completed

NCT Number: NCT00516048

An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes

The primary purpose of this study is 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Keswick, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with type 2 diabetes.
  • Have been exposed to exenatide for at least 3 months in previous Amylin/Lilly Studies H8O-MC-GWAO, H8O-MC-GWAP, H8O-MC-GWAT, or H8O-MC-GWBA.
  • Have interrupted exenatide treatment for a period of at least 2 months.
  • HbA1c of ≤10.5%.

Exclusion criteria

  • 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.
  • Have previously completed or withdrawn from this study.
  • Have taken marketed exenatide (Byetta) during the interim period between studies GWAO, GWAP, GWAT, or GWBA and the current study.
  • Used drugs for weight loss (for example, Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], Accomplia® [rimonabant], or similar over-the-counter medications) within 3 months of screening.
  • Are currently treated with any of the following excluded medications: Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
  • Use insulin with daily dosage exceeding 1 U/kg.

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5mcg or 10mcg, twice a day

Other names: Byetta, AC2993, LY2148568

Primary outcomes

  1. Treatment-emergent Antibody Status (Maximum Titer Level Experienced)

    Time frame: 24 weeks

    Patients who experienced specified treatment-emergent antibody status at any point during the study (grouped by maximum titer level experienced)

  2. Incidence of Potentially Immune-related Treatment-emergent Adverse Events

    Time frame: 24 weeks

    Number of patients experiencing a potentially immune-related treatment-emergent adverse event at any point during the study

Secondary outcomes

  1. Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint

    Time frame: 24 weeks

    Change in HbA1c from baseline (Week 0) to endpoint (Week 24) by treatment-emergent antibody status

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 14, 2007
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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