Type 2 Diabetes
Conditions
Keywords
diabetes, type 2
Brief summary
This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.
Interventions
DRUGRosuvastatin
Oral
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Type 2 diabetes * Previously treated with a commonly accepted start dose of a statin for the last 4 weeks prior to study entry * Fasting LDL-C concentration of \> 2.0 mmol/L (and ≤ 5.0 mmol/L) (in the past 3 months) * History of serum TG level of ≤ 4.6 mmol/l (in the past 3 months)
Exclusion criteria
* If currently receiving therapy with any statin at a dose higher than listed * Rosuvastatin (current use) * Fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to enrolment. * Type 1 diabetes; glycated haemoglobin (HbA1c) \> 9.0% * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 1.5 × upper limit of normal (ULN) (in the past 2 months) * Resting diastolic or systolic blood pressure of \> 95 mmHg or \> 180 mmHg, respectively (in the past 2 months) * Unexplained serum creatine kinase (CK) level \> 3 × ULN (in the past 2 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 Weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage 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 | 6 and 12 Weeks | Proportion 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 |
| Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio | 6 and 12 Weeks | — |
| Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12 | 6 and 12 Weeks | — |
| Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy | 6 and 12 Weeks | — |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Rosuvastatin 10 mg (Initial) 10 mg rosuvastatin (RSV) as initial dose | 319 |
| Rosuvastatin 20 mg (Initial) 20 mg RSV as initial dose | 279 |
| Total | 598 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 15 |
| Overall Study | Did not receive treatment | 0 | 1 |
| Overall Study | Incorrect enrollment | 0 | 6 |
| Overall Study | Lost to Follow-up | 0 | 10 |
| Overall Study | Not reported | 1 | 4 |
| Overall Study | Severe non-compliance to protocol | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 6 |
Baseline characteristics
| Characteristic | Rosuvastatin 10 mg (Initial) | Rosuvastatin 20 mg (Initial) | Total |
|---|---|---|---|
| Age Continuous | 63.2 Years STANDARD_DEVIATION 10.9 | 62.6 Years STANDARD_DEVIATION 10.5 | 62.9 Years STANDARD_DEVIATION 10.7 |
| Body Mass Index BMI | 32.50 kg/m^2 STANDARD_DEVIATION 6.89 | 32.27 kg/m^2 STANDARD_DEVIATION 6.72 | 32.39 kg/m^2 STANDARD_DEVIATION 6.81 |
| Race/Ethnicity, Customized Asian | 22 Participants | 17 Participants | 39 Participants |
| Race/Ethnicity, Customized Black/African American | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 10 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 288 Participants | 245 Participants | 533 Participants |
| Sex: Female, Male Female | 150 Participants | 145 Participants | 295 Participants |
| Sex: Female, Male Male | 169 Participants | 134 Participants | 303 Participants |
| Waistline circumference | 106.7 cm STANDARD_DEVIATION 14.9 | 106.7 cm STANDARD_DEVIATION 15.9 | 106.7 cm STANDARD_DEVIATION 15.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 14 / 319 | 4 / 232 | 9 / 279 | 3 / 182 | 2 / 75 | 0 / 78 |
| serious Total, serious adverse events | 4 / 319 | 2 / 232 | 0 / 279 | 0 / 182 | 1 / 75 | 1 / 78 |
Outcome results
Primary
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
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
Time frame: 12 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 10 mg (Initial) | 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 |
| Rosuvastatin 20 mg (Initial) | 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 81 |
| Rosuvastatin 20 mg (Titrated) | 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 | 76 Percentage | 95% Confidence Interval 65 |
| Rosuvastatin 40 mg (Titrated) | 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 | 63 Percentage | 95% Confidence Interval 52 |
Secondary
Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy
Time frame: 6 and 12 Weeks
Secondary
Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12
Time frame: 6 and 12 Weeks
Secondary
Mean Percent Change in Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDLC) , TC/HDL-C Ratio, Non-HDL-C, Triglycerides and Apolipoprotein B (ApoB) /Apolipoprotein A1 (ApoA-1) Ratio
Time frame: 6 and 12 Weeks
Secondary
Percentage 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
Proportion 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
Time frame: 6 and 12 Weeks