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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00747149

First received: September 2, 2008

Last updated: August 29, 2011

Last verified: August 2011

History of Changes

Results First Received: August 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Intervention:	Drug: Rosuvastatin

Participant Flow

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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

Baseline Characteristics

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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
Number of Participants [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)

Outcome Measures

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 ]

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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 ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

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 ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

4. Secondary:

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

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

5. Secondary:

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

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00747149 History of Changes
Other Study ID Numbers:	D3560L00072
Study First Received:	September 2, 2008
Results First Received:	August 6, 2010
Last Updated:	August 29, 2011
Health Authority:	Canada: Ethics Review Committee

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