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):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01029886

First received: December 8, 2009

Last updated: March 20, 2015

Last verified: March 2015

History of Changes

Results First Received: February 14, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; 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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Baseline Characteristics

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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.
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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
Overall Participants Analyzed [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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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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Measure Type	Secondary
Measure Title	Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26
Measure Description	Change in DBP from baseline to the treatment endpoint at Week 26.
Time Frame	Baseline, Week 26

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. All observed data from all scheduled visits (including early termination visits) were included in the MMRM analysis. Data collected at the early termination visits were mapped into the following scheduled visits.

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
Participants Analyzed [Units: Participants]	404	398
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26 [Units: mmHg] Least Squares Mean (Standard Error)	-0.49 (0.37)	-0.51 (0.37)

Statistical Analysis 1 for Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26

Groups ^[1]	All groups
Statistical Test Type ^[2]	Superiority or Other
Statistical Method ^[3]	Mixed Models Analysis
P Value ^[4]	0.981
Least Squares Mean Difference ^[5]	0.01
95% Confidence Interval	-0.96 to 0.98
Standard Error of the mean	(0.50)

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
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[3]	Other relevant method information, such as adjustments or degrees of freedom:
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[4]	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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[5]	Other relevant estimation information:
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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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Limitations and Caveats

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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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