NCT01876849

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P25-P50 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
Last Updated

February 24, 2015

Status Verified

January 1, 2015

Enrollment Period

4.6 years

First QC Date

July 14, 2009

Last Update Submit

February 23, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesexenatideByettaAmylinLilly

Outcome Measures

Primary Outcomes (1)

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

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

    128 weeks (average treatment period)

Study Arms (1)

Group A

EXPERIMENTAL

Exenatide injection 5mcg or 10 mcg, twice daily

Drug: exenatide

Interventions

exenatideDRUG

subcutaneous injection, 5mcg or 10 mcg, twice daily

Also known as: Byetta
Group A

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Renton, Washington, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Chief Medical Officer, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

June 13, 2013

Study Start

December 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 24, 2015

Record last verified: 2015-01

Locations

US(1)