A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Amylin Pharmaceuticals, LLC.

ClinicalTrials.gov Identifier:

NCT00917267

First received: June 8, 2009

Last updated: November 28, 2012

Last verified: November 2012

History of Changes

Results First Received: February 14, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: exenatide once weekly Drug: exenatide twice daily

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
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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 Once Weekly	Subcutaneous injection of 2 mg exenatide, once a week
Exenatide Twice Daily	Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)

Participant Flow: Overall Study

	Exenatide Once Weekly	Exenatide Twice Daily
STARTED	346	345
Intent to Treat (ITT)	340	338
COMPLETED	307	266
NOT COMPLETED	39	79
Adverse Event	15	36
Physician Decision	2	4
Protocol Violation	9	18
Withdrawal by Subject	5	12
Lost to follow up	0	2
Entry Criteria Not Met	1	0
Sponsor Decision	5	5
Lack of Efficacy-Loss of Glucose Control	2	2

Baseline Characteristics

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Reporting Groups

	Description
Exenatide Once Weekly	Subcutaneous injection of 2 mg exenatide, once a week
Exenatide Twice Daily	Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
Total	Total of all reporting groups

Baseline Measures

	Exenatide Once Weekly	Exenatide Twice Daily	Total
Number of Participants [units: participants]	340	338	678
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	275	274	549
>=65 years	65	64	129
Age [units: years] Mean ± Standard Deviation	55.4 ± 10.59	56.2 ± 9.99	55.8 ± 10.30
Gender [units: participants]
Female	157	154	311
Male	183	184	367
Glycosylated hemoglobin (HbA1c) [units: percentage of total hemoglobin] Mean ± Standard Deviation	8.7 ± 1.04	8.7 ± 1.03	8.7 ± 1.03
Weight [units: kg] Mean ± Standard Deviation	69.6 ± 12.44	70.4 ± 12.09	70.0 ± 12.26
Background Oral Antidiabetic Agent (OAD) [units: participants]
Metformin (MET)	62	60	122
MET+Sulfonylurea (SU)	210	216	426
MET+SU+Thiazolidinedione (TZD)	6	10	16
MET+TZD	12	9	21
SU	30	29	59
SU+TZD	18	12	30
TZD	2	2	4

Outcome Measures

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1. Primary:

Change in HbA1c From Baseline to Week 26. [ Time Frame: Baseline, Week 26 ]

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2. Secondary:

Percentage of Patients Achieving HbA1c Targets <=7% at Week 26 [ Time Frame: Baseline, Week 26 ]

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3. Secondary:

Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26 [ Time Frame: Baseline, Week 26 ]

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4. Secondary:

Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]

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5. Secondary:

Change in Body Weight (BW) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]

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6. Secondary:

Change in Total Cholesterol (TC) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]

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7. Secondary:

Change in High-Density Lipoprotein (HDL) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]

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8. Secondary:

Ratio of Triglycerides (TG) at Week 26 to Baseline [ Time Frame: Baseline, Week 26 ]

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9. Secondary:

Change in Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]

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10. Secondary:

Assessment of Event Rate of Treatment-emergent Hypoglycemic Events [ Time Frame: Baseline to Week 26 ]

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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: 1-877-285-4559
e-mail: clinicaltrials@amylin.com

No publications provided

Responsible Party:	Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:	NCT00917267 History of Changes
Other Study ID Numbers:	H8O-MC-GWCK
Study First Received:	June 8, 2009
Results First Received:	February 14, 2012
Last Updated:	November 28, 2012
Health Authority:	China: Food and Drug Administration India: Drugs Controller General of India Japan: Pharmaceuticals and Medical Devices Agency South Korea: Korea Food and Drug Administration (KFDA) Taiwan: Department of Health

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