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OpenTrials
Completed

NCT Number: NCT01876849

An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

The aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies H8O-MC-GWAA and H8O-MC-GWAD.

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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

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site

Renton, Washington, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the respective study.

Exclusion criteria

  • Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD.
  • 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.

Treatment and study plan

exenatide

Drug

subcutaneous injection, 5mcg or 10 mcg, twice daily

Other names: Byetta

Primary outcomes

  1. Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events.

    Time frame: 128 weeks (average treatment period)

    Visits for this study occur at 6-mo (±2 wk) intervals until exenatide is approved for marketing.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2013
Registry last updated
Feb 24, 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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