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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Coronary Disease Cardiovascular Diseases Heart Diseases Insulin Resistance Diabetes Mellitus Diabetes Mellitus, Non-Insulin-Dependent |
| Interventions: |
Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Procedure: Coronary Artery Bypass Drug: Biguanides, thiazolidinediones Drug: Insulin, sulfonylurea Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| A total of 2,368 patients were enrolled at 49 clinical centers from United States, Canada, Brazil, Mexico, Czech Republic, and Austria between January 1, 2001 and March 31, 2005. Each of the 2368 patients was simultaneously assigned to initial revascularization or medical therapy and assigned to insulin providing or insulin sensitizing therapy. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Revascularization and Insulin Providing (IP) | Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy |
| Revascularization and Insulin Sensitizing (IS) | Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy |
| Medical Therapy and Insulin Providing (IP) | Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy |
| Medical Therapy and Insulin Sensitizing (IS) | Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy |
| Revascularization and Insulin Providing (IP) | Revascularization and Insulin Sensitizing (IS) | Medical Therapy and Insulin Providing (IP) | Medical Therapy and Insulin Sensitizing (IS) | |
|---|---|---|---|---|
| STARTED | 592 | 584 | 593 | 599 |
| COMPLETED | 575 | 574 | 578 | 585 |
| NOT COMPLETED | 17 | 10 | 15 | 14 |
| Withdrawal by Subject | 17 | 10 | 15 | 14 |
Baseline Characteristics
| Description | |
|---|---|
| Revascularization and Insulin Providing (IP) | Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy |
| Revascularization and Insulin Sensitizing (IS) | Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy |
| Medical Therapy and Insulin Providing (IP) | Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy |
| Medical Therapy and Insulin Sensitizing (IS) | Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy |
| Revascularization and Insulin Providing (IP) | Revascularization and Insulin Sensitizing (IS) | Medical Therapy and Insulin Providing (IP) | Medical Therapy and Insulin Sensitizing (IS) | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
592 | 584 | 593 | 599 | 2368 |
|
Age
[units: participants] |
|||||
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 362 | 354 | 350 | 373 | 1439 |
| >=65 years | 230 | 230 | 243 | 226 | 929 |
|
Age
[units: years] Mean ± Standard Deviation |
62.3 ± 8.5 | 62.4 ± 9.1 | 62.7 ± 8.8 | 62.2 ± 9.3 | 62.4 ± 8.9 |
|
Gender
[units: participants] |
|||||
| Female | 176 | 172 | 172 | 182 | 702 |
| Male | 416 | 412 | 421 | 417 | 1666 |
|
Region of Enrollment
[units: participants] |
|||||
| United States | 376 | 367 | 376 | 380 | 1499 |
| Canada | 87 | 88 | 89 | 89 | 353 |
| Brazil | 89 | 89 | 89 | 89 | 356 |
| Mexico | 21 | 21 | 22 | 21 | 85 |
| Europe | 19 | 19 | 17 | 20 | 75 |
Outcome Measures
More Information
| 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. |
| 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 |
|---|
| No text entered. |
| Responsible Party: | Maria Mori Brooks, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00006305 History of Changes |
| Other Study ID Numbers: | 133, U01HL061744, U01HL061746, U01HL061748, U01HL063804 |
| Study First Received: | September 28, 2000 |
| Results First Received: | January 27, 2011 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Federal Government |
