52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
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ClinicalTrials.gov Identifier: NCT00575588 |
Recruitment Status :
Completed
First Posted : December 18, 2007
Results First Posted : September 6, 2010
Last Update Posted : March 21, 2012
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Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Type 2 Diabetes |
Interventions |
Drug: Metformin Drug: Sulphonylurea Drug: Saxagliptin |
Enrollment | 891 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated. |
Arm/Group Title | Saxagliptin + Metformin | Glipizide + Metformin |
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Saxagliptin 5 mg tablets added on to open-label metformin | Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin |
Period Title: Overall Study | ||
Started | 428 [1] | 430 [1] |
Completed | 165 [2] | 147 [2] |
Not Completed | 263 | 283 |
Reason Not Completed | ||
Adverse Event | 11 | 13 |
Withdrawal by Subject | 27 | 31 |
Lost to Follow-up | 1 | 3 |
Death | 4 | 2 |
Incorrect enrollment | 8 | 4 |
Study specific discontinuation criteria | 203 | 218 |
Severe non-compliance to protocol | 5 | 7 |
Safety reasons | 2 | 1 |
Elevated triglyceride | 1 | 0 |
Patient moved | 1 | 3 |
Impossible to determine HbA1c | 0 | 1 |
[1]
Randomized and treated
[2]
Completed 104 weeks of treatment
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Baseline Characteristics
Arm/Group Title | Saxagliptin + Metformin | Glipizide + Metformin | Total | |
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Saxagliptin 5 mg tablets added on to open-label metformin | Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin | Total of all reporting groups | |
Overall Number of Baseline Participants | 428 | 430 | 858 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 428 participants | 430 participants | 858 participants | |
57.50 (10.26) | 57.59 (10.37) | 57.55 (10.31) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 428 participants | 430 participants | 858 participants | |
Female |
216 50.5%
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198 46.0%
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414 48.3%
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Male |
212 49.5%
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232 54.0%
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444 51.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Gerard Lynch |
Organization: | AstraZeneca |
EMail: | aztrial_results_posting@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00575588 |
Other Study ID Numbers: |
D1680C00001 EudraCT number 2007-003998-55 |
First Submitted: | December 14, 2007 |
First Posted: | December 18, 2007 |
Results First Submitted: | August 10, 2010 |
Results First Posted: | September 6, 2010 |
Last Update Posted: | March 21, 2012 |