Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00765817 |
Recruitment Status :
Completed
First Posted : October 3, 2008
Results First Posted : January 26, 2011
Last Update Posted : October 24, 2016
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Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Type 2 Diabetes |
Interventions |
Drug: placebo Drug: exenatide |
Enrollment | 261 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Two subjects who started the study, subsequently withdrew prior to receiving study medication and are not part of the full analysis set |
Arm/Group Title | Exenatide Arm | Placebo Arm |
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Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents) | Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents) |
Period Title: Overall Study | ||
Started | 138 [1] | 123 [1] |
Completed | 112 | 101 |
Not Completed | 26 | 22 |
Reason Not Completed | ||
Adverse Event | 13 | 1 |
Death | 0 | 1 |
Entry criteria not met | 2 | 2 |
Loss of glucose control | 0 | 2 |
Lost to Follow-up | 1 | 3 |
Physician Decision | 2 | 1 |
Protocol Violation | 1 | 1 |
Subject decision | 7 | 11 |
[1]
One subject withdrew prior to receiving study medication, not included in analysis set
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Baseline Characteristics
Arm/Group Title | Exenatide Arm | Placebo Arm | Total | |
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Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents) | Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents) | Total of all reporting groups | |
Overall Number of Baseline Participants | 137 | 122 | 259 | |
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One subject per group withdrew from the study prior to the first dose of study medication and therefore are not part of the baseline or subsequent analysis.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 137 participants | 122 participants | 259 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
100 73.0%
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84 68.9%
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184 71.0%
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>=65 years |
37 27.0%
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38 31.1%
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75 29.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 137 participants | 122 participants | 259 participants | |
58.67 (8.91) | 59.40 (9.96) | 59.01 (9.41) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 137 participants | 122 participants | 259 participants | |
Female |
67 48.9%
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44 36.1%
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111 42.9%
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Male |
70 51.1%
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78 63.9%
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148 57.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Peter Ohman, Medical Science Director |
Organization: | AstraZeneca |
EMail: | ClinicalTrialTransparency@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00765817 |
Other Study ID Numbers: |
H8O-US-GWCO |
First Submitted: | October 1, 2008 |
First Posted: | October 3, 2008 |
Results First Submitted: | January 4, 2011 |
Results First Posted: | January 26, 2011 |
Last Update Posted: | October 24, 2016 |