52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00575588
First received: December 14, 2007
Last updated: March 20, 2012
Last verified: March 2012
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Results First Received: August 10, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Type 2 Diabetes |
| Interventions: |
Drug: Metformin Drug: Sulphonylurea Drug: Saxagliptin |
Participant Flow
Hide 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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 891 participants were enrolled in the study; 33 participants did not enter the treatment period; 858 participants were randomized and treated. |
Reporting Groups
| Description | |
|---|---|
| Saxagliptin + Metformin | Saxagliptin 5 mg tablets added on to open-label metformin |
| Glipizide + Metformin | Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin |
Participant Flow: Overall Study
| Saxagliptin + Metformin | Glipizide + Metformin | |
|---|---|---|
| STARTED | 428 [1] | 430 [1] |
| COMPLETED | 165 [2] | 147 [2] |
| NOT COMPLETED | 263 | 283 |
| 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 |
Baseline Characteristics
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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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Saxagliptin + Metformin | Saxagliptin 5 mg tablets added on to open-label metformin |
| Glipizide + Metformin | Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin |
| Total | Total of all reporting groups |
Baseline Measures
| Saxagliptin + Metformin | Glipizide + Metformin | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
428 | 430 | 858 |
|
Age
[units: years] Mean (Standard Deviation) |
57.50 (10.26) | 57.59 (10.37) | 57.55 (10.31) |
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Gender
[units: Participants] |
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| Female | 216 | 198 | 414 |
| Male | 212 | 232 | 444 |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 [ Time Frame: Baseline to 52 Weeks ] |
| 2. Secondary: | Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks [ Time Frame: From Baseline to Week 52 ] |
| 3. Secondary: | Body Weight Change From Baseline to Week 52 [ Time Frame: Baseline, Week 52 (Last Observation Carried Forward) ] |
| 4. Secondary: | Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c [ Time Frame: Week 24 to Week 52 ] |
| 5. Other Pre-specified: | Hemoglobin A1c (HbA1c) Change From Baseline to Week 104 [ Time Frame: Baseline, Week 104 ] |
| 6. Other Pre-specified: | Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 104 Weeks [ Time Frame: Baseline, Week 104 ] |
| 7. Other Pre-specified: | Body Weight Change From Baseline to Week 104 [ Time Frame: Baseline, Week 104 ] |
| 8. Other Pre-specified: | Mean Slope of the Regressions of Change From Week 24 to Week 104 in HbA1c [ Time Frame: Week 24 to Week 104 ] |
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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| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT 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. |
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00575588 History of Changes |
| Other Study ID Numbers: |
D1680C00001 EudraCT number 2007-003998-55 |
| Study First Received: | December 14, 2007 |
| Results First Received: | August 10, 2010 |
| Last Updated: | March 20, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |