Trial Outcomes & Findings for A Diabetes Study to Treat A Population Previously Not at Target (NCT NCT00747149)
NCT ID: NCT00747149
Last Updated: 2011-08-31
Results Overview
The number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
598 participants
Primary outcome timeframe
12 Weeks
Results posted on
2011-08-31
Participant Flow
A total of 1044 patients (adult male and non-pregnant females) were enrolled at 122 Canadian family practice sites between May 2008 and May 2009. Out of these, only 598 patients were allocated to treatment. The remaining 446 did not receive treatment as they did not fulfill the inclusion/exclusion criteria.
Following enrolment, at Visit 1 the patients' Low Density Lipoprotein Cholesterol (LDL-C) value was baselined. If LDL-C value from Visit 1 was \> 2.00, but ≤ 2.50 mmol/L: patients received Rosuvastatin (RSV)10 mg under the RSV 10 mg arm. If LDL-C value from Visit 1 was \> 2.50 mmol/L: patients received Rosuvastatin 20 mg under the RSV 20 mg arm.
Participant milestones
| Measure |
Rosuvastatin Titrated
10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
|
Rosuvastatin Non-titrated
10 mg RSV or 20 mg RSV
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
444
|
|
Overall Study
COMPLETED
|
153
|
401
|
|
Overall Study
NOT COMPLETED
|
1
|
43
|
Reasons for withdrawal
| Measure |
Rosuvastatin Titrated
10 mg rosuvastatin (RSV) as initial dose followed by 20 mg RSV as titrated dose or 20 mg rosuvastatin (RSV) as initial dose followed by 40 mg RSV as titrated dose
|
Rosuvastatin Non-titrated
10 mg RSV or 20 mg RSV
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
15
|
|
Overall Study
Lost to Follow-up
|
0
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
|
Overall Study
Did not receive treatment
|
0
|
1
|
|
Overall Study
Incorrect enrollment
|
0
|
6
|
|
Overall Study
Severe non-compliance to protocol
|
0
|
1
|
|
Overall Study
Not reported
|
1
|
4
|
Baseline Characteristics
A Diabetes Study to Treat A Population Previously Not at Target
Baseline characteristics by cohort
| Measure |
Rosuvastatin 10 mg (Initial)
n=319 Participants
10 mg rosuvastatin (RSV) as initial dose
|
Rosuvastatin 20 mg (Initial)
n=279 Participants
20 mg RSV as initial dose
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.2 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
62.6 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
62.9 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
288 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
533 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Body Mass Index
BMI
|
32.50 kg/m^2
STANDARD_DEVIATION 6.89 • n=5 Participants
|
32.27 kg/m^2
STANDARD_DEVIATION 6.72 • n=7 Participants
|
32.39 kg/m^2
STANDARD_DEVIATION 6.81 • n=5 Participants
|
|
Waistline circumference
|
106.7 cm
STANDARD_DEVIATION 14.9 • n=5 Participants
|
106.7 cm
STANDARD_DEVIATION 15.9 • n=7 Participants
|
106.7 cm
STANDARD_DEVIATION 15.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksThe number of subjects achieving Canadian Low density lipoprotein cholesterol (LDL-C) target goals (i.e. LDL-C ≤ 2.0 mmol/L) over the total number subjects treated after 12 weeks of rosuvastatin therapy multiplied by 100
Outcome measures
| Measure |
Rosuvastatin 10 mg (Initial)
n=225 Participants
At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
|
Rosuvastatin 20 mg (Initial)
n=176 Participants
At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
|
Rosuvastatin 20 mg (Titrated)
n=75 Participants
At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
|
Rosuvastatin 40 mg (Titrated)
n=78 Participants
At visit 1, LDL C level was measured. At visit 2, subjects received treatments with rosuvastatin 10 mg or 20 mg based on their visit 1 LDLC level. At visit 3 (6 weeks after visit 2) LDLC values was measured again and patients were titrated to the next highest dose of rosuvastatin if they had not reached target level of LDLC. Hence, 4 arms are listed, subjects who started on 10 mg could be on 10mg, 20mg by the end of the study and those subjects who started on 20mg could be on 20mg or 40 mg at the end of the study.
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving Canadian Low Density Lipoprotein Cholesterol (LDL-C) Target Goals (i.e. LDL-C ≤ 2.0 mmol/L) After 12 Weeks of Rosuvastatin Therapy
|
87 Percentage
95% Confidence Interval 82 • Interval 82.0 to 91.0
|
87 Percentage
95% Confidence Interval 81 • Interval 81.0 to 91.0
|
76 Percentage
95% Confidence Interval 65 • Interval 65.0 to 84.0
|
63 Percentage
95% Confidence Interval 52 • Interval 52.0 to 73.0
|
SECONDARY outcome
Timeframe: 6 and 12 WeeksProportion of subjects achieving total cholesterol (TC)/ High-density lipoprotein cholesterol (HDLC) ratio (i.e. TC/HDL \< 4.0 mmol/L) at 6 and 12 weeks of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 WeeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 WeeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 and 12 WeeksOutcome measures
Outcome data not reported
Adverse Events
Rosuvastatin 10 mg (Initial)
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Rosuvastatin 10 mg (Continued, Non-titrated)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Rosuvastatin 20 mg (Initial)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Rosuvastatin 20 mg (Continued, Non-titrated)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Rosuvastatin 20 mg (Titrated)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Rosuvastatin 40 mg (Titrated)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rosuvastatin 10 mg (Initial)
n=319 participants at risk
10 mg rosuvastatin (RSV) as initial dose
|
Rosuvastatin 10 mg (Continued, Non-titrated)
n=232 participants at risk
10 mg RSV as a continued, non-titrated dose
|
Rosuvastatin 20 mg (Initial)
n=279 participants at risk
20 mg RSV as initial dose
|
Rosuvastatin 20 mg (Continued, Non-titrated)
n=182 participants at risk
20 mg RSV as continued, non-titrated dose
|
Rosuvastatin 20 mg (Titrated)
n=75 participants at risk
20 mg RSV as titrated dose
|
Rosuvastatin 40 mg (Titrated)
n=78 participants at risk
20 mg RSV as titrated dose
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Labyrinthitis
|
0.00%
0/319
|
0.43%
1/232
|
0.00%
0/279
|
0.00%
0/182
|
0.00%
0/75
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/319
|
0.00%
0/232
|
0.00%
0/279
|
0.00%
0/182
|
1.3%
1/75
|
0.00%
0/78
|
|
Renal and urinary disorders
Renal Colic
|
0.31%
1/319
|
0.00%
0/232
|
0.00%
0/279
|
0.00%
0/182
|
0.00%
0/75
|
0.00%
0/78
|
|
Injury, poisoning and procedural complications
Chemical Poisoning
|
0.00%
0/319
|
0.43%
1/232
|
0.00%
0/279
|
0.00%
0/182
|
0.00%
0/75
|
0.00%
0/78
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.31%
1/319
|
0.00%
0/232
|
0.00%
0/279
|
0.00%
0/182
|
0.00%
0/75
|
0.00%
0/78
|
|
Cardiac disorders
Aortic Aneurysm Rupture
|
0.00%
0/319
|
0.00%
0/232
|
0.00%
0/279
|
0.00%
0/182
|
0.00%
0/75
|
1.3%
1/78
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.31%
1/319
|
0.00%
0/232
|
0.00%
0/279
|
0.00%
0/182
|
0.00%
0/75
|
0.00%
0/78
|
|
Renal and urinary disorders
Urinary Retention
|
0.31%
1/319
|
0.00%
0/232
|
0.00%
0/279
|
0.00%
0/182
|
0.00%
0/75
|
0.00%
0/78
|
Other adverse events
| Measure |
Rosuvastatin 10 mg (Initial)
n=319 participants at risk
10 mg rosuvastatin (RSV) as initial dose
|
Rosuvastatin 10 mg (Continued, Non-titrated)
n=232 participants at risk
10 mg RSV as a continued, non-titrated dose
|
Rosuvastatin 20 mg (Initial)
n=279 participants at risk
20 mg RSV as initial dose
|
Rosuvastatin 20 mg (Continued, Non-titrated)
n=182 participants at risk
20 mg RSV as continued, non-titrated dose
|
Rosuvastatin 20 mg (Titrated)
n=75 participants at risk
20 mg RSV as titrated dose
|
Rosuvastatin 40 mg (Titrated)
n=78 participants at risk
20 mg RSV as titrated dose
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.6%
5/319
|
0.00%
0/232
|
2.2%
6/279
|
1.1%
2/182
|
0.00%
0/75
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
7/319
|
0.43%
1/232
|
0.72%
2/279
|
0.55%
1/182
|
0.00%
0/75
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.63%
2/319
|
1.3%
3/232
|
0.36%
1/279
|
0.00%
0/182
|
2.7%
2/75
|
0.00%
0/78
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed in order for AstraZeneca to file patent applications.
- Publication restrictions are in place
Restriction type: OTHER