Effect on Weight Loss of Exenatide Versus Placebo - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: exenatide Drug: placebo

Participant Flow

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 [ 24 weeks ]

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2. Secondary:

Change in Glycosylated Hemoglobin (HbA1c) [ 24 weeks ]

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3. Secondary:

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

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4. Secondary:

Change in Waist Circumference. [ 24 weeks ]

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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Measure Type	Secondary
Measure Title	Change in Low Density Lipoprotein (LDL) Cholesterol
Measure Description	Change in LDL cholesterol from baseline after 24 weeks of treatment (i.e., LDL cholesterol at week 24 minus LDL cholesterol at week 0)
Time Frame	24 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat population

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

Measured Values

	Group A (Exenatide)	Group B (Placebo)
Number of Participants Analyzed [units: participants]	81	89
Change in Low Density Lipoprotein (LDL) Cholesterol [units: mmol/L] Least Squares Mean ± Standard Error
Change in LDL cholesterol at week 24	-0.06 ± 0.08	-0.04 ± 0.07

Statistical Analysis 1 for Change in Low Density Lipoprotein (LDL) Cholesterol

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.8334

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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9. Secondary:

Change in Total Cholesterol [ 24 weeks ]

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10. Secondary:

Change in Triglycerides [ 24 weeks ]

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11. Secondary:

Incidence of Hypoglycemic Events [ 24 weeks ]

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12. Secondary:

Rate of Hypoglycemic Events [ 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 )
Study ID Numbers:	H8O-US-GWBM
Study First Received:	September 11, 2006
Results First Received:	February 25, 2009
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00375492 History of Changes
Health Authority:	United States: Food and Drug Administration