Effect on Weight Loss of Exenatide Versus Placebo

This study has been completed.

Study NCT00375492 Information provided by Amylin Pharmaceuticals, Inc.

Study First Received: September 11, 2006 Last Updated: July 1, 2010 History of Changes

Results First Received: February 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Control: Placebo Control; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: exenatide Drug: placebo

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
Group A (Exenatide)	exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
Group B (Placebo)	placebo (volume equivalent to exenatide injection) twice daily for 24 weeks

Participant Flow: Overall Study

	Group A (Exenatide)	Group B (Placebo)
STARTED	96	98
COMPLETED	70	72
NOT COMPLETED	26	26
Adverse Event	4	5
Entry Criteria Not Met	0	1
Loss of Glucose Control	0	1
Lost to Follow-up	10	5
Physician Decision	0	4
Protocol Violation	6	3
Sponsor Decision	0	1
Subject Decision	6	6

Baseline Characteristics

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Reporting Groups

	Description
Group A (Exenatide)	exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
Group B (Placebo)	placebo (volume equivalent to exenatide injection) twice daily for 24 weeks

Baseline Measures

	Group A (Exenatide)	Group B (Placebo)	Total
Number of Participants [units: participants]	96	98	194
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	78	82	160
>=65 years	18	16	34
Age [units: years] Mean ± Standard Deviation	54.52 ± 10.02	55.08 ± 8.97	54.81 ± 9.48
Gender [units: participants]
Female	60	61	121
Male	36	37	73
Baseline Body Weight [units: kg] Mean ± Standard Deviation	94.90 ± 16.52	96.16 ± 16.53	95.53 ± 16.05
Baseline Cholesterol [units: mmol/L] Mean ± Standard Deviation	4.67 ± 1.03	4.68 ± 0.90	4.68 ± 0.96
Baseline Glycosylated Hemoglobin (HbA1c) [units: %] Mean ± Standard Deviation	7.74 ± 0.87	7.51 ± 0.82	7.62 ± 0.85
Baseline High Density Lipoprotein (HDL) Cholesterol [units: mmol/L] Mean ± Standard Deviation	1.18 ± 0.32	1.21 ± 0.31	1.20 ± 0.31
Baseline Homeostatic Model Assessment-Beta Cell (HOMA-B) [units: %] Mean ± Standard Deviation	75.15 ± 81.20	70.72 ± 53.16	72.81 ± 67.65
Baseline Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) [units: %] Mean ± Standard Deviation	49.72 ± 32.12	62.90 ± 41.07	56.68 ± 37.57
Baseline Low Density Lipoprotein (LDL) Cholesterol [units: mmol/L] Mean ± Standard Deviation	2.74 ± 0.88	2.78 ± 0.82	2.76 ± 0.85
Baseline Triglycerides [units: mmol/L] Mean ± Standard Deviation	2.15 ± 0.94	2.13 ± 1.00	2.14 ± 0.97
Baseline Waist Circumference [units: cm] Mean ± Standard Deviation	109.64 ± 11.12	108.85 ± 12.10	109.24 ± 11.60

Outcome Measures

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1. Primary:

Change in Body Weight [ Time Frame: 24 weeks ]

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2. Secondary:

Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 24 weeks ]

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3. Secondary:

Change in 6-point Self Monitored Blood Glucose (SMBG) Profile. [ Time Frame: 24 weeks ]

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4. Secondary:

Change in Waist Circumference. [ Time Frame: 24 weeks ]

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5. Secondary:

Change in Homeostatic Model Assessment-Beta Cell (HOMA-B) [ Time Frame: 24 weeks ]

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6. Secondary:

Change in Homeostatic Model Assessment-Insulin Sensitivity (HOMA-S) [ Time Frame: 24 weeks ]

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7. Secondary:

Change in High Density Lipoprotein (HDL) Cholesterol [ Time Frame: 24 weeks ]

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8. Secondary:

Change in Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: 24 weeks ]

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9. Secondary:

Change in Total Cholesterol [ Time Frame: 24 weeks ]

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10. Secondary:

Change in Triglycerides [ Time Frame: 24 weeks ]

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11. Secondary:

Incidence of Hypoglycemic Events [ Time Frame: 24 weeks ]

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12. Secondary:

Rate of Hypoglycemic Events [ 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:	Eli Lilly and Company ( James Malone, MD, Study Director )
ClinicalTrials.gov Identifier:	NCT00375492 History of Changes
Other Study ID Numbers:	H8O-US-GWBM
Study First Received:	September 11, 2006
Results First Received:	February 25, 2009
Last Updated:	July 1, 2010
Health Authority:	United States: Food and Drug Administration