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

This study has been completed.

Study NCT00516048 Information provided by Amylin Pharmaceuticals, Inc.

First Received on August 10, 2007. Last Updated on April 29, 2009 History of Changes

Results First Received: April 29, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Intervention:	Drug: exenatide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Following a period of treatment interruption of at least 2 months, patients for this study were recruited from among patients who were previously exposed to exenatide for at least 3 months in Amylin/Lilly studies GWAO, GWAP, GWAT, and GWBA.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Exenatide:Treatment-Emergent Antibody Negative	5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
Exenatide: Treatment-Emergent Antibody Positive	5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodoes to exenatide at any point in the study.
Enrolled But Withdrew Before Receiving Treatment	No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.

Participant Flow: Overall Study

	Exenatide:Treatment-Emergent Antibody Negative	Exenatide: Treatment-Emergent Antibody Positive	Enrolled But Withdrew Before Receiving Treatment
STARTED	15	42	1
COMPLETED	15	40	0
NOT COMPLETED	0	2	1
Death	0	0	1
Subject Decision	0	2	0

Baseline Characteristics

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Reporting Groups

	Description
Negative Baseline (Week 0) Antibody Status	Patients assessed as negative for antibodies to exenatide at baseline (Week 0).
Positive Baseline (Week 0) Antibody Status	Patients assessed as positive for antibodies to exenatide at baseline (Week 0).

Baseline Measures

	Negative Baseline (Week 0) Antibody Status	Positive Baseline (Week 0) Antibody Status	Total
Number of Participants [units: participants]	50	8	58
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	31	8	39
>=65 years	19	0	19
Age [units: years] Mean ± Standard Deviation	60.65 ± 8.95	49.88 ± 9.84	59.17 ± 9.74
Gender [units: participants]
Female	20	5	25
Male	30	3	33

Outcome Measures

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1. Primary:

Treatment-emergent Antibody Status (Maximum Titer Level Experienced) [ Time Frame: 24 weeks ]

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2. Primary:

Incidence of Potentially Immune-related Treatment-emergent Adverse Events [ Time Frame: 24 weeks ]

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3. Secondary:

Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint [ Time Frame: 24 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-LILLYRX
e-mail: clinicaltrials@amylin.com

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00516048 History of Changes
Other Study ID Numbers:	H8O-MC-GWBO
Study First Received:	August 10, 2007
Results First Received:	April 29, 2009
Last Updated:	April 29, 2009
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Hungary: National Institute of Pharmacy Italy: Ministry of Health South Korea: Korea Food and Drug Administration (KFDA)