Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

This study has been completed.

Sponsor:

Collaborator:

Eli Lilly and Company

Information provided by (Responsible Party):

Amylin Pharmaceuticals, LLC.

ClinicalTrials.gov Identifier:

NCT01029886

First received: December 8, 2009

Last updated: January 14, 2013

Last verified: January 2013

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: liraglutide

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, 2mg, once weekly
Liraglutide Once Daily	Subcutaneous injection, forced titration to 1.8mg, once daily

Participant Flow: Overall Study

	Exenatide Once Weekly	Liraglutide Once Daily
STARTED	461	451
Intent to Treat (ITT)	461	450
COMPLETED	400	391
NOT COMPLETED	61	60
Adverse Event	12	25
Lost to Follow-up	1	0
Physician Decision	2	6
Protocol Violation	17	5
Withdrawal by Subject	8	18
Entry Criteria Not Met	13	5
Sponsor Decision	1	0
Loss Glucose Control	7	1

Baseline Characteristics

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Reporting Groups

	Description
Exenatide Once Weekly	Subcutaneous injection, 2mg, once weekly
Liraglutide Once Daily	Subcutaneous injection, forced titration to 1.8mg, once daily
Total	Total of all reporting groups

Baseline Measures

	Exenatide Once Weekly	Liraglutide Once Daily	Total
Number of Participants [units: participants]	461	450	911
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	386	360	746
>=65 years	75	90	165
Age [units: years] Mean ± Standard Deviation	56.6 ± 9.43	56.7 ± 9.59	56.6 ± 9.51
Gender [units: participants]
Female	207	205	412
Male	254	245	499
Glycosylated hemoglobin (HbA1c) [units: percentage of total hemoglobin] Mean ± Standard Deviation	8.45 ± 1.014	8.43 ± 0.996	8.44 ± 1.004
Weight [units: kg] Mean ± Standard Deviation	90.88 ± 19.472	91.13 ± 19.118	91.00 ± 19.288
Background Oral Antidiabetic Agent (OAD) [units: participants]
Metformin (MET)	150	136	286
Sulfonylurea (SU)	18	18	36
Pioglitazone (PIO)	1	0	1
MET+SU	275	277	552
MET+PIO	16	18	34
MET+SU+PIO	1	1	2

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 <7.0% at Week 26 [ Time Frame: Baseline, Week 26 ]

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Measure Type	Secondary
Measure Title	Percentage of Patients Achieving HbA1c <7.0% at Week 26
Measure Description	Percentage of patients achieving HbA1c <7.0% at treatment endpoint at Week 26.
Time Frame	Baseline, Week 26
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.
ITT Population. Missing data at endpoint was imputed using last observation carried forward approach.

Reporting Groups

	Description
Exenatide Once Weekly	Subcutaneous injection, 2mg, once weekly
Liraglutide Once Daily	Subcutaneous injection, forced titration to 1.8mg, once daily

Measured Values

	Exenatide Once Weekly	Liraglutide Once Daily
Number of Participants Analyzed [units: participants]	461	450
Percentage of Patients Achieving HbA1c <7.0% at Week 26 [units: percentage of patients]	52.7	60.2

Statistical Analysis 1 for Percentage of Patients Achieving HbA1c <7.0% at Week 26

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.011

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Percentage of patients achieving HbA1c <7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.
[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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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

Ratio of Fasting Triglycerides at Week 26 to Baseline [ Time Frame: Baseline, Week 26 ]

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8. Secondary:

Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]

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9. Secondary:

Change in Diastolic Blood Pressure (DBP) 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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