A Diabetes Study to Treat A Population Previously Not at Target (ADAPT)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow:   Overall Study

	Rosuvastatin Titrated	Rosuvastatin Non-titrated
STARTED	154	444
COMPLETED	153	401
NOT COMPLETED	1	43
Adverse Event	0	15
Lost to Follow-up	0	10
Withdrawal by Subject	0	6
Did not receive treatment	0	1
Incorrect enrollment	0	6
Severe non-compliance to protocol	0	1
Not reported	1	4

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Rosuvastatin 10 mg (Initial)	10 mg rosuvastatin (RSV) as initial dose
Rosuvastatin 20 mg (Initial)	20 mg RSV as initial dose
Total	Total of all reporting groups

Baseline Measures

	Rosuvastatin 10 mg (Initial)	Rosuvastatin 20 mg (Initial)	Total
Overall Participants Analyzed  [Units: Participants]	319	279	598
Age  [Units: Years] Mean (Standard Deviation)	63.2  (10.9)	62.6  (10.5)	62.9  (10.7)
Gender  [Units: Participants]
Female	150	145	295
Male	169	134	303
Race/Ethnicity, Customized  [Units: Participants]
White	288	245	533
Black/African American	5	7	12
Asian	22	17	39
Other	4	10	14
Body Mass Index  [Units: Kg/m^2] Mean (Standard Deviation)
BMI	32.50  (6.89)	32.27  (6.72)	32.39  (6.81)
Waistline circumference  [Units: Cm] Mean (Standard Deviation)	106.7  (14.9)	106.7  (15.9)	106.7  (15.4)

1.  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   [ Time Frame: 12 Weeks ]

2.  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   [ Time Frame: 6 and 12 Weeks ]

3.  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 ]

4.  Secondary:

Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12   [ Time Frame: 6 and 12 Weeks ]

5.  Secondary:

Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy   [ Time Frame: 6 and 12 Weeks ]

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
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