Trial Outcomes & Findings for Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (NCT NCT00006305)
NCT ID: NCT00006305
Last Updated: 2016-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2368 participants
Primary outcome timeframe
five years
Results posted on
2016-02-08
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
592
|
584
|
593
|
599
|
|
Overall Study
COMPLETED
|
575
|
574
|
578
|
585
|
|
Overall Study
NOT COMPLETED
|
17
|
10
|
15
|
14
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
10
|
15
|
14
|
Baseline Characteristics
Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Revascularization and Insulin Providing (IP)
n=592 Participants
Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
|
Revascularization and Insulin Sensitizing (IS)
n=584 Participants
Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
|
Medical Therapy and Insulin Providing (IP)
n=593 Participants
Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
|
Medical Therapy and Insulin Sensitizing (IS)
n=599 Participants
Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
|
Total
n=2368 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
702 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
416 Participants
n=5 Participants
|
412 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
417 Participants
n=4 Participants
|
1666 Participants
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
362 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
373 Participants
n=4 Participants
|
1439 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
230 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
929 Participants
n=21 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
62.2 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
62.4 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Region of Enrollment
United States
|
376 participants
n=5 Participants
|
367 participants
n=7 Participants
|
376 participants
n=5 Participants
|
380 participants
n=4 Participants
|
1499 participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
87 participants
n=5 Participants
|
88 participants
n=7 Participants
|
89 participants
n=5 Participants
|
89 participants
n=4 Participants
|
353 participants
n=21 Participants
|
|
Region of Enrollment
Brazil
|
89 participants
n=5 Participants
|
89 participants
n=7 Participants
|
89 participants
n=5 Participants
|
89 participants
n=4 Participants
|
356 participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
22 participants
n=5 Participants
|
21 participants
n=4 Participants
|
85 participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
17 participants
n=5 Participants
|
20 participants
n=4 Participants
|
75 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: five yearsPopulation: Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)
Outcome measures
| Measure |
Revascularization and Insulin Providing (IP)
n=592 Participants
Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
|
Revascularization and Insulin Sensitizing (IS)
n=584 Participants
Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
|
Medical Therapy and Insulin Providing (IP)
n=593 Participants
Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
|
Medical Therapy and Insulin Sensitizing (IS)
n=599 Participants
Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
|
|---|---|---|---|---|
|
Number of Participants With All-Cause Mortality
|
80 participants
|
75 participants
|
80 participants
|
81 participants
|
SECONDARY outcome
Timeframe: five yearsPopulation: Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)
Outcome measures
| Measure |
Revascularization and Insulin Providing (IP)
n=592 Participants
Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
|
Revascularization and Insulin Sensitizing (IS)
n=584 Participants
Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
|
Medical Therapy and Insulin Providing (IP)
n=593 Participants
Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
|
Medical Therapy and Insulin Sensitizing (IS)
n=599 Participants
Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
|
|---|---|---|---|---|
|
Number of Participants With Death, Myocardial Infarction, or Stroke
|
145 participants
|
121 participants
|
143 participants
|
140 participants
|
Adverse Events
Revascularization and Insulin Providing (IP)
Serious events: 230 serious events
Other events: 331 other events
Deaths: 0 deaths
Revascularization and Insulin Sensitizing (IS)
Serious events: 210 serious events
Other events: 362 other events
Deaths: 0 deaths
Medical Therapy and Insulin Providing (IP)
Serious events: 230 serious events
Other events: 344 other events
Deaths: 0 deaths
Medical Therapy and Insulin Sensitizing (IS)
Serious events: 235 serious events
Other events: 363 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Revascularization and Insulin Providing (IP)
n=592 participants at risk
Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
|
Revascularization and Insulin Sensitizing (IS)
n=584 participants at risk
Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
|
Medical Therapy and Insulin Providing (IP)
n=593 participants at risk
Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
|
Medical Therapy and Insulin Sensitizing (IS)
n=599 participants at risk
Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
|
|---|---|---|---|---|
|
Cardiac disorders
Death
|
13.5%
80/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
12.8%
75/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
13.5%
80/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
13.5%
81/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
|
Cardiac disorders
Myocardial Infarction
|
11.3%
67/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
8.7%
51/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
12.0%
71/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
11.2%
67/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
|
Vascular disorders
Stroke
|
2.9%
17/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
2.2%
13/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
3.2%
19/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
2.3%
14/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
|
Endocrine disorders
Severe Hypoglycemia
|
7.8%
46/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
6.2%
36/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
10.5%
62/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
5.3%
32/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
|
Cardiac disorders
Congestive Heart Failure
|
18.8%
111/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
20.4%
119/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
18.0%
107/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
21.5%
129/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
Other adverse events
| Measure |
Revascularization and Insulin Providing (IP)
n=592 participants at risk
Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
|
Revascularization and Insulin Sensitizing (IS)
n=584 participants at risk
Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
|
Medical Therapy and Insulin Providing (IP)
n=593 participants at risk
Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
|
Medical Therapy and Insulin Sensitizing (IS)
n=599 participants at risk
Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
|
|---|---|---|---|---|
|
General disorders
Pitting Edema
|
49.5%
293/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
54.3%
317/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
51.3%
304/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
55.9%
335/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
6.4%
38/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
8.2%
48/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
6.1%
36/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
5.7%
34/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
|
Eye disorders
Laser Therapy for Macular Edema
|
7.9%
47/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
7.2%
42/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
8.8%
52/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
9.0%
54/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
|
Vascular disorders
Lower Extremity Ulcer
|
9.3%
55/592 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
9.4%
55/584 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
8.1%
48/593 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
7.2%
43/599 • 5 years
Clinic visits conducted monthly for first 6 months and every 3 months thereafter until the study ended.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place