A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
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| ClinicalTrials.gov Identifier: NCT00295633 |
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Recruitment Status :
Completed
First Posted : February 24, 2006
Results First Posted : September 25, 2009
Last Update Posted : April 7, 2015
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Diabetes Mellitus, Type 2 |
| Interventions |
Drug: Saxagliptin Drug: Placebo Drug: pioglitazone Drug: rosiglitazone Drug: metformin |
| Enrollment | 565 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD) | Saxagliptin 5 mg Plus Open-label TZD | Placebo Plus Open-label TZD |
|---|---|---|---|
 Arm/Group Description |
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg. | The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg. | The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg. |
| Period Title: Overall Study | |||
| Started | 195 | 186 | 184 |
| Completed Study Without Being Rescued | 88 | 82 | 51 |
| Completed | 133 | 119 | 108 |
| Not Completed | 62 | 67 | 76 |
| Reason Not Completed | |||
| Lack of Efficacy | 19 | 7 | 16 |
| Withdrawal of consent by subject | 16 | 16 | 26 |
| Adverse Event | 9 | 17 | 9 |
| Lost to Follow-up | 6 | 11 | 7 |
| Physician Decision | 9 | 10 | 8 |
| Poor/Noncompliance | 2 | 2 | 6 |
| Subject No Longer Meets Study Criteria | 0 | 3 | 3 |
| Death | 1 | 1 | 0 |
| Administrative reason by sponsor | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Saxagliptin 2.5 mg Plus Open-label TZD | Saxagliptin 5 mg Plus Open-label TZD | Placebo Plus Open-label TZD | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg. | The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg. | The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 195 | 186 | 184 | 565 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 195 participants | 186 participants | 184 participants | 565 participants | |
| 54.85 (9.73) | 53.22 (10.56) | 54.01 (10.08) | 54.04 (10.13) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 195 participants | 186 participants | 184 participants | 565 participants | |
| Female |
89 45.6%
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97 52.2%
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99 53.8%
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285 50.4%
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| Male |
106 54.4%
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89 47.8%
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85 46.2%
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280 49.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
| Name/Title: | Boaz Hirschberg |
| Organization: | AstraZeneca Pharmaceuticals |
| EMail: | ClinicalTrialTransparency@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00295633 |
| Other Study ID Numbers: |
CV181-013 |
| First Submitted: | February 22, 2006 |
| First Posted: | February 24, 2006 |
| Results First Submitted: | August 17, 2009 |
| Results First Posted: | September 25, 2009 |
| Last Update Posted: | April 7, 2015 |