Trial Outcomes & Findings for Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes (NCT NCT00116831)
NCT ID: NCT00116831
Last Updated: 2017-03-23
Results Overview
The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
672 participants
Primary outcome timeframe
Baseline to Month 18
Results posted on
2017-03-23
Participant Flow
Participant milestones
| Measure |
Glipizide (GLP) 5 mg
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Overall Study
STARTED
|
337
|
331
|
|
Overall Study
COMPLETED
|
264
|
259
|
|
Overall Study
NOT COMPLETED
|
73
|
72
|
Reasons for withdrawal
| Measure |
Glipizide (GLP) 5 mg
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
14
|
16
|
|
Overall Study
Baseline IVUS determined unevaluable
|
12
|
11
|
|
Overall Study
Lost to Follow-up
|
8
|
6
|
|
Overall Study
Protocol Violation
|
3
|
6
|
|
Overall Study
Hypoglycaemic events
|
1
|
0
|
|
Overall Study
Low haemoglobin on screening
|
1
|
0
|
|
Overall Study
Withdrawn investigational product
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
32
|
32
|
|
Overall Study
Insufficient therapeutic effect
|
0
|
1
|
|
Overall Study
Missing data for participant
|
1
|
0
|
Baseline Characteristics
Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Glipizide (GLP) 5 mg
n=337 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=331 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
Total
n=668 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 8.38 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
221 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
255 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
495 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
70 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Pre-study Treatment
Diet and exercise regimen only
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Pre-study Treatment
Oral anti-diabetic monotherapy
|
183 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Pre-study Treatment
Oral anti-diabetic dual therapy
|
90 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Smoking history
Never smoked
|
152 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Smoking history
Current smoker
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Smoking history
Former smoker
|
128 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Smoking history
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29 kilograms per square meter (kg/m2)
n=5 Participants
|
28 kilograms per square meter (kg/m2)
n=7 Participants
|
29 kilograms per square meter (kg/m2)
n=5 Participants
|
|
Duration of cardiovascular disease
|
0.79 Years
n=5 Participants
|
0.59 Years
n=7 Participants
|
0.73 Years
n=5 Participants
|
|
Duration of diabetes
|
4.62 Years
n=5 Participants
|
4.96 Years
n=7 Participants
|
4.74 Years
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit \[≥ 9 months\] IVUS imaging assessment.)
The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
Month 18
|
41.013 percent (absolute change)
Standard Deviation 11.1572
|
40.182 percent (absolute change)
Standard Deviation 11.4257
|
|
Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
Change from Baseline
|
0.420 percent (absolute change)
Standard Deviation 4.8085
|
-0.240 percent (absolute change)
Standard Deviation 4.2421
|
|
Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
Baseline
|
40.593 percent (absolute change)
Standard Deviation 10.9717
|
40.422 percent (absolute change)
Standard Deviation 11.7506
|
PRIMARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population (Defined as all randomized participants who received at least one dose of study medication, with an evaluable Baseline and exit \[≥ 9 months\] IVUS imaging assessment.)
Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD).
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18
|
0.43 percent (absolute change)
Standard Error 0.331
|
-0.21 percent (absolute change)
Standard Error 0.331
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Atheroma Volume, Month 18
|
249.625 millimeters cubed (mm3)
Standard Deviation 149.7098
|
218.576 millimeters cubed (mm3)
Standard Deviation 134.3462
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Change from Baseline in Atheroma Volume
|
-0.123 millimeters cubed (mm3)
Standard Deviation 28.1627
|
-3.854 millimeters cubed (mm3)
Standard Deviation 25.8846
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Vessel Volume, Baseline
|
609.378 millimeters cubed (mm3)
Standard Deviation 311.7587
|
555.062 millimeters cubed (mm3)
Standard Deviation 297.9848
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Vessel Volume, Month 18
|
603.088 millimeters cubed (mm3)
Standard Deviation 304.3434
|
547.186 millimeters cubed (mm3)
Standard Deviation 298.2100
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Atheroma Volume, Baseline
|
249.747 millimeters cubed (mm3)
Standard Deviation 150.4095
|
222.431 millimeters cubed (mm3)
Standard Deviation 137.4193
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Change from Baseline in Vessel Volume
|
-6.290 millimeters cubed (mm3)
Standard Deviation 52.7032
|
-7.876 millimeters cubed (mm3)
Standard Deviation 40.4948
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Lumen Volume, Baseline
|
359.726 millimeters cubed (mm3)
Standard Deviation 195.6810
|
332.688 millimeters cubed (mm3)
Standard Deviation 192.3850
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Lumen Volume, Month 18
|
353.513 millimeters cubed (mm3)
Standard Deviation 192.2419
|
328.676 millimeters cubed (mm3)
Standard Deviation 191.9313
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18
Change from Baseline in Lumen Volume
|
-6.213 millimeters cubed (mm3)
Standard Deviation 56.0042
|
-4.012 millimeters cubed (mm3)
Standard Deviation 38.5260
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Atheroma Volume to Month 18
|
0.98 millimeters cubed (mm3)
Standard Error 2.001
|
-3.60 millimeters cubed (mm3)
Standard Error 2.002
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Lumen Volume to Month 18
|
-4.91 millimeters cubed (mm3)
Standard Error 3.545
|
-4.59 millimeters cubed (mm3)
Standard Error 3.526
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Vessel Volume to Month 18
|
-4.56 millimeters cubed (mm3)
Standard Error 3.479
|
-8.13 millimeters cubed (mm3)
Standard Error 3.466
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Atheroma Area, Baseline
|
5.918 millimeters squared (mm2)
Standard Deviation 2.9281
|
5.748 millimeters squared (mm2)
Standard Deviation 2.5585
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Atheroma Area, Month 18
|
5.928 millimeters squared (mm2)
Standard Deviation 2.9615
|
5.634 millimeters squared (mm2)
Standard Deviation 2.5594
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Change from Baseline in Atheroma Area
|
0.010 millimeters squared (mm2)
Standard Deviation 0.6448
|
-0.114 millimeters squared (mm2)
Standard Deviation 0.6990
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Change from Baseline in Lumen Area
|
-0.113 millimeters squared (mm2)
Standard Deviation 1.2166
|
-0.075 millimeters squared (mm2)
Standard Deviation 0.9207
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Vessel Area, Baseline
|
14.364 millimeters squared (mm2)
Standard Deviation 5.1946
|
14.166 millimeters squared (mm2)
Standard Deviation 4.8231
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Vessel Area, Month 18
|
14.261 millimeters squared (mm2)
Standard Deviation 5.1699
|
13.977 millimeters squared (mm2)
Standard Deviation 4.8595
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Change from Baseline in Vessel Area
|
-0.102 millimeters squared (mm2)
Standard Deviation 1.1954
|
-0.189 millimeters squared (mm2)
Standard Deviation 0.9918
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Lumen Area, Baseline
|
8.447 millimeters squared (mm2)
Standard Deviation 3.2037
|
8.419 millimeters squared (mm2)
Standard Deviation 3.2847
|
|
Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18
Lumen Area, Month 18
|
8.335 millimeters squared (mm2)
Standard Deviation 3.2056
|
8.344 millimeters squared (mm2)
Standard Deviation 3.3077
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Atheroma Area to Month 18
|
0.03 millimeters square (mm2)
Standard Error 0.050
|
-0.10 millimeters square (mm2)
Standard Error 0.050
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Lumen Area to Month 18
|
-0.14 millimeters square (mm2)
Standard Error 0.079
|
-0.11 millimeters square (mm2)
Standard Error 0.079
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Vessel Area to Month 18
|
-0.10 millimeters square (mm2)
Standard Error 0.082
|
-0.21 millimeters square (mm2)
Standard Error 0.082
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change From Baseline in Normalized Atheroma Volume
Baseline
|
232.772 millimeters cubed (mm3)
Standard Deviation 115.1630
|
226.075 millimeters cubed (mm3)
Standard Deviation 100.6261
|
|
Change From Baseline in Normalized Atheroma Volume
Month 18
|
233.153 millimeters cubed (mm3)
Standard Deviation 116.4765
|
221.599 millimeters cubed (mm3)
Standard Deviation 100.6606
|
|
Change From Baseline in Normalized Atheroma Volume
Change from Baseline
|
0.381 millimeters cubed (mm3)
Standard Deviation 25.3600
|
-4.476 millimeters cubed (mm3)
Standard Deviation 27.4901
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population
IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change From Baseline in Normalized Atheroma Volume
|
1.20 millimeters cubed (mm3)
Standard Error 1.974
|
-3.92 millimeters cubed (mm3)
Standard Error 1.983
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population with last observation carried forward (LOCF)
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
Baseline
|
75.649 millimeters cubed (mm3)
Standard Deviation 32.6125
|
70.961 millimeters cubed (mm3)
Standard Deviation 29.9610
|
|
Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
Month 18
|
72.225 millimeters cubed (mm3)
Standard Deviation 33.2887
|
66.020 millimeters cubed (mm3)
Standard Deviation 30.7228
|
|
Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
Change from Baseline
|
-3.424 millimeters cubed (mm3)
Standard Deviation 11.9263
|
-4.941 millimeters cubed (mm3)
Standard Deviation 12.2005
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population with last observation carried forward (LOCF)
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
|
-3.56 millimeters cubed (mm3)
Standard Error 0.892
|
-5.28 millimeters cubed (mm3)
Standard Error 0.898
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population with last observation carried forward (LOCF)
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
Baseline
|
7.569 millimeters squared (mm2)
Standard Deviation 3.2718
|
7.093 millimeters squared (mm2)
Standard Deviation 3.0042
|
|
Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
Change from Baseline
|
-0.384 millimeters squared (mm2)
Standard Deviation 1.0608
|
-0.468 millimeters squared (mm2)
Standard Deviation 1.1370
|
|
Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
Month 18
|
7.185 millimeters squared (mm2)
Standard Deviation 3.2957
|
6.625 millimeters squared (mm2)
Standard Deviation 3.0741
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: IVUS Evaluable Population with last observation carried forward (LOCF)
IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=229 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=233 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline
|
-0.39 millimeters squared (mm2)
Standard Error 0.081
|
-0.50 millimeters squared (mm2)
Standard Error 0.082
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: Intent-to-Treat (ITT) Population without Last Observation Carried Forward (LOCF). ITT population was defined as all participants in the study who were randomized and have at least one on-therapy value for an efficacy assessment.
From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=321 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=311 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18
|
-0.20 Percentage
Standard Error 0.051
|
-0.30 Percentage
Standard Error 0.053
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=273 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=255 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18
|
-0.46 millimole/Liter (mmol/L)
Standard Error 0.138
|
-1.34 millimole/Liter (mmol/L)
Standard Error 0.145
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=316 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=302 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18
Adjusted Geometric Mean + Standard Error
|
-62.82 percent change
-67.40
|
-80.33 percent change
-82.84
|
|
Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18
Adjusted Geometric Mean
|
-65.18 percent change
|
-81.63 percent change
|
|
Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18
Adjusted Geometric Mean - Standard Error
|
-67.40 percent change
|
-82.84 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=298 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=291 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18
Adjusted Geometric Mean + Standard Error
|
-26.5 percent change
-34.3
|
-38.8 percent change
-45.5
|
|
Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18
Adjusted Geometric Mean
|
-30.5 percent change
|
-42.2 percent change
|
|
Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18
Adjusted Geometric Mean - Standard Error
|
-34.3 percent change
|
-45.5 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population with LOCF
It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=212 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=199 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
Mean + Standard Error
|
1.141 percent change
-13.764
|
30.189 percent change
11.683
|
|
Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
Mean - Standard Error
|
-13.764 percent change
|
11.683 percent change
|
|
Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
Mean
|
-6.608 percent change
|
20.582 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population with LOCF
It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=212 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=199 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
Adjusted Geometric Mean + Standard Error
|
-4.865 percent change
-17.465
|
24.576 percent change
7.499
|
|
Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
Adjusted Geometric Mean
|
-11.388 percent change
|
15.720 percent change
|
|
Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18
Adjusted Geometric Mean - Standard Error
|
-17.465 percent change
|
7.499 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=272 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=263 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in Total Cholesterol (TC)
Adjusted Geometric Mean
|
-5.644 percent change
|
1.567 percent change
|
|
Percent Change From Baseline to Month 18 in Total Cholesterol (TC)
Adjusted Geometric Mean - Standard Error
|
-7.062 percent change
|
0.007 percent change
|
|
Percent Change From Baseline to Month 18 in Total Cholesterol (TC)
Adjusted Geometric Mean + Standard Error
|
-4.205 percent change
|
3.151 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=269 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=261 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)
Adjusted Geometric Mean + Standard Error
|
7.208 percent change
|
15.104 percent change
|
|
Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)
Adjusted Geometric Mean
|
5.710 percent change
|
13.440 percent change
|
|
Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)
Adjusted Geometric Mean - Standard Error
|
4.233 percent change
|
11.808 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=269 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=260 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in HDL-2
Adjusted Geometric Mean + Standard Error
|
2.065 percent change
|
18.241 percent change
|
|
Percent Change From Baseline to Month 18 in HDL-2
Adjusted Geometric Mean
|
-0.783 percent change
|
14.821 percent change
|
|
Percent Change From Baseline to Month 18 in HDL-2
Adjusted Geometric Mean - Standard Error
|
-3.550 percent change
|
11.507 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=269 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=260 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in HDL-3
Adjusted Geometric Mean + Standard Error
|
10.683 percent change
|
15.165 percent change
|
|
Percent Change From Baseline to Month 18 in HDL-3
Adjusted Geometric Mean
|
9.074 percent change
|
13.440 percent change
|
|
Percent Change From Baseline to Month 18 in HDL-3
Adjusted Geometric Mean - Standard Error
|
7.490 percent change
|
11.732 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=261 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=252 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)
Adjusted Geometric Mean + Standard Error
|
-8.955 percent change
|
1.795 percent change
|
|
Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)
Adjusted Geometric Mean
|
-11.600 percent change
|
-1.237 percent change
|
|
Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)
Adjusted Geometric Mean - Standard Error
|
-14.172 percent change
|
-4.180 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=241 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=229 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in Triglycerides (TG)
Adjusted Geometric Mean + Standard Error
|
-7.415 percent change
|
-13.601 percent change
|
|
Percent Change From Baseline to Month 18 in Triglycerides (TG)
Adjusted Geometric Mean
|
-10.309 percent change
|
-16.381 percent change
|
|
Percent Change From Baseline to Month 18 in Triglycerides (TG)
Adjusted Geometric Mean - Standard Error
|
-13.110 percent change
|
-19.067 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=236 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=229 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)
Adjusted Geometric Mean - Standard Error
|
21.943 percent change
|
4.142 percent change
|
|
Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)
Adjusted Geometric Mean + Standard Error
|
32.909 percent change
|
13.835 percent change
|
|
Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)
Adjusted Geometric Mean
|
27.303 percent change
|
8.880 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=280 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=273 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Percent Change From Baseline to Month 18 in Apoprotein B (apoB)
Adjusted Geometric Mean + Standard Error
|
-6.588 percent change
-10.021
|
-6.967 percent change
-10.488
|
|
Percent Change From Baseline to Month 18 in Apoprotein B (apoB)
Adjusted Geometric Mean
|
-8.320 percent change
|
-8.744 percent change
|
|
Percent Change From Baseline to Month 18 in Apoprotein B (apoB)
Adjusted Geometric Mean - Standard Error
|
-10.021 percent change
|
-10.488 percent change
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=267 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=262 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation
|
0.0040 Ratio
Standard Error 0.00158
|
0.0204 Ratio
Standard Error 0.001630
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=263 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=253 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio
|
-0.495 ratio
Standard Error 0.08380
|
-0.377 ratio
Standard Error 0.08620
|
SECONDARY outcome
Timeframe: Baseline to Month 18Population: ITT Population without LOCF
From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=252 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=242 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Change From Baseline to Month 18 in LDL-c/HDL-c Ratio
|
-0.365 ratio
Standard Error 0.0610
|
-0.226 ratio
Standard Error 0.0629
|
SECONDARY outcome
Timeframe: Baseline to Month 21Population: Safety Population
This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=337 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=331 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)
|
38 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 21Population: Safety Population
This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=337 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=331 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 21Population: Safety Population
This was one of the secondary endpoints of the study.
Outcome measures
| Measure |
Glipizide (GLP) 5 mg
n=337 Participants
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=331 Participants
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Number of Other Cardiovascular Events
All-cause death
|
7 Number of events
|
8 Number of events
|
|
Number of Other Cardiovascular Events
Cardiovascular death
|
3 Number of events
|
4 Number of events
|
|
Number of Other Cardiovascular Events
Non-fatal myocardial infarction
|
6 Number of events
|
7 Number of events
|
|
Number of Other Cardiovascular Events
Non-fatal stroke
|
1 Number of events
|
5 Number of events
|
|
Number of Other Cardiovascular Events
Coronary revascularization
|
27 Number of events
|
26 Number of events
|
|
Number of Other Cardiovascular Events
Hospitalization for recurrent myocardial ischemia
|
7 Number of events
|
11 Number of events
|
|
Number of Other Cardiovascular Events
Non-MACE congestive heart failure
|
3 Number of events
|
8 Number of events
|
Adverse Events
Glipizide (GLP) 5 mg
Serious events: 71 serious events
Other events: 117 other events
Deaths: 0 deaths
Rosiglitazone (RSG) 4 mg
Serious events: 71 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glipizide (GLP) 5 mg
n=337 participants at risk
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=331 participants at risk
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
3.0%
10/337
|
3.6%
12/331
|
|
Cardiac disorders
Angina unstable
|
2.4%
8/337
|
1.2%
4/331
|
|
Cardiac disorders
Coronary artery stenosis
|
0.89%
3/337
|
0.60%
2/331
|
|
Cardiac disorders
Coronary artery disease
|
0.59%
2/337
|
0.30%
1/331
|
|
Cardiac disorders
Acute coronary syndrome
|
0.59%
2/337
|
0.00%
0/331
|
|
Cardiac disorders
Acute myocardial infarction
|
0.59%
2/337
|
0.00%
0/331
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/337
|
0.30%
1/331
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Atrial flutter
|
0.30%
1/337
|
0.00%
0/331
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Cardiogenic shock
|
0.30%
1/337
|
0.00%
0/331
|
|
Cardiac disorders
Cardiovascular disorder
|
0.30%
1/337
|
0.00%
0/331
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Palpitations
|
0.00%
0/337
|
0.30%
1/331
|
|
Cardiac disorders
Prinzmetal angina
|
0.30%
1/337
|
0.00%
0/331
|
|
General disorders
Chest pain
|
2.4%
8/337
|
1.8%
6/331
|
|
General disorders
Non-cardiac chest pain
|
1.2%
4/337
|
0.30%
1/331
|
|
General disorders
Death
|
0.30%
1/337
|
0.30%
1/331
|
|
General disorders
Fatigue
|
0.30%
1/337
|
0.00%
0/331
|
|
General disorders
Ill-defined disorder
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Oedema peripheral
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Pyrexia
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Sudden cardiac death
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/337
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.00%
0/337
|
0.91%
3/331
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/337
|
0.60%
2/331
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.30%
1/337
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.30%
1/337
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/337
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.30%
1/337
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.30%
1/337
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.30%
1/337
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/337
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/337
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/337
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Postoperative thrombosis
|
0.30%
1/337
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/337
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.30%
1/337
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/337
|
0.30%
1/331
|
|
Gastrointestinal disorders
Colitis
|
0.30%
1/337
|
0.30%
1/331
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/337
|
0.60%
2/331
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/337
|
0.30%
1/331
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Constipation
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Dyspepsia
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Enteritis
|
0.30%
1/337
|
0.00%
0/331
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/337
|
0.30%
1/331
|
|
Gastrointestinal disorders
Gastritis
|
0.30%
1/337
|
0.00%
0/331
|
|
General disorders
Gastrointestinal haemorrhage
|
0.30%
1/337
|
0.00%
0/331
|
|
Gastrointestinal disorders
Pancreatitis
|
0.30%
1/337
|
0.00%
0/331
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/337
|
0.30%
1/331
|
|
General disorders
Umbilical hernia
|
0.00%
0/337
|
0.30%
1/331
|
|
Nervous system disorders
Cerebrovascular accident
|
0.30%
1/337
|
0.60%
2/331
|
|
Nervous system disorders
Loss of consciousness
|
0.30%
1/337
|
0.30%
1/331
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/337
|
0.30%
1/331
|
|
Nervous system disorders
Carotid artery stenosis
|
0.30%
1/337
|
0.00%
0/331
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/337
|
0.30%
1/331
|
|
Nervous system disorders
Dizziness
|
0.00%
0/337
|
0.30%
1/331
|
|
Nervous system disorders
Presyncope
|
0.00%
0/337
|
0.30%
1/331
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/337
|
0.30%
1/331
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/337
|
0.30%
1/331
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.59%
2/337
|
0.60%
2/331
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/337
|
0.30%
1/331
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/337
|
0.00%
0/331
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/337
|
0.30%
1/331
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/337
|
0.30%
1/331
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.30%
1/337
|
0.00%
0/331
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/337
|
0.30%
1/331
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.30%
1/337
|
0.00%
0/331
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.30%
1/337
|
0.00%
0/331
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/337
|
0.30%
1/331
|
|
Infections and infestations
Bronchitis
|
0.30%
1/337
|
0.00%
0/331
|
|
Infections and infestations
Dengue fever
|
0.00%
0/337
|
0.30%
1/331
|
|
Infections and infestations
Erysipelas
|
0.00%
0/337
|
0.30%
1/331
|
|
Infections and infestations
Febrile infection
|
0.00%
0/337
|
0.30%
1/331
|
|
Infections and infestations
Influenza
|
0.00%
0/337
|
0.30%
1/331
|
|
Infections and infestations
Pneumonia
|
0.30%
1/337
|
0.00%
0/331
|
|
Infections and infestations
Respiratory tract infection
|
0.30%
1/337
|
0.00%
0/331
|
|
Infections and infestations
Septic shock
|
0.30%
1/337
|
0.00%
0/331
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/337
|
0.30%
1/331
|
|
Vascular disorders
Hypotension
|
0.00%
0/337
|
0.60%
2/331
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.59%
2/337
|
0.00%
0/331
|
|
Vascular disorders
Haematoma
|
0.00%
0/337
|
0.30%
1/331
|
|
Vascular disorders
Haemorrhage
|
0.30%
1/337
|
0.00%
0/331
|
|
Vascular disorders
Hypertension
|
0.30%
1/337
|
0.00%
0/331
|
|
Vascular disorders
Hypertensive crisis
|
0.30%
1/337
|
0.00%
0/331
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/337
|
0.30%
1/331
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/337
|
0.30%
1/331
|
|
Renal and urinary disorders
Renal failure acute
|
0.30%
1/337
|
0.30%
1/331
|
|
Renal and urinary disorders
Calculus ureteric
|
0.30%
1/337
|
0.00%
0/331
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/337
|
0.30%
1/331
|
|
Renal and urinary disorders
Nephroangiosclerosis
|
0.00%
0/337
|
0.30%
1/331
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/337
|
0.30%
1/331
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/337
|
0.30%
1/331
|
|
Renal and urinary disorders
Renal failure
|
0.30%
1/337
|
0.00%
0/331
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/337
|
0.30%
1/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/337
|
0.30%
1/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.30%
1/337
|
0.00%
0/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/337
|
0.30%
1/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.30%
1/337
|
0.00%
0/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.30%
1/337
|
0.00%
0/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.30%
1/337
|
0.00%
0/331
|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
1/337
|
0.91%
3/331
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/337
|
0.30%
1/331
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/337
|
0.30%
1/331
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
1/337
|
0.00%
0/331
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/337
|
0.00%
0/331
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/337
|
0.30%
1/331
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/337
|
0.30%
1/331
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.30%
1/337
|
0.00%
0/331
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/337
|
0.30%
1/331
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/337
|
0.30%
1/331
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.59%
2/337
|
0.00%
0/331
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.30%
1/337
|
0.00%
0/331
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.30%
1/337
|
0.00%
0/331
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
1/337
|
0.30%
1/331
|
|
Psychiatric disorders
Adjustment disorder with mixed disturbance of emotion and cond
|
0.30%
1/337
|
0.00%
0/331
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/337
|
0.30%
1/331
|
|
Psychiatric disorders
Depression
|
0.30%
1/337
|
0.00%
0/331
|
|
Eye disorders
Macular hole
|
0.00%
0/337
|
0.30%
1/331
|
|
Investigations
Cardiac enzymes increased
|
0.30%
1/337
|
0.00%
0/331
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.30%
1/337
|
0.00%
0/331
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/337
|
0.30%
1/331
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/337
|
0.30%
1/331
|
Other adverse events
| Measure |
Glipizide (GLP) 5 mg
n=337 participants at risk
Glipizide (GLP) 5 mg once daily for 18 months
|
Rosiglitazone (RSG) 4 mg
n=331 participants at risk
Rosiglitazone (RSG) 4 mg once daily for 18 months
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
9.8%
33/337
|
9.4%
31/331
|
|
General disorders
Edema peripheral
|
7.1%
24/337
|
8.8%
29/331
|
|
Vascular disorders
Hypertension
|
6.2%
21/337
|
3.9%
13/331
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
20/337
|
3.9%
13/331
|
|
Nervous system disorders
Dizziness
|
5.0%
17/337
|
4.8%
16/331
|
|
General disorders
Fatigue
|
3.9%
13/337
|
5.4%
18/331
|
|
Nervous system disorders
Headache
|
5.9%
20/337
|
3.3%
11/331
|
|
General disorders
Chest pain
|
5.0%
17/337
|
3.3%
11/331
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER