A Diabetes Study to Treat A Population Previously Not at Target

Type 2 Diabetes Clinical Trial

— ADAPT  

Official title:

12-week, Open-label, Multi-center, Prospective Study Evaluating the Effect of Individualizing Starting Doses of Rosuvastatin According to Baseline LDL (Low Density Lipoprotein)-Cholesterol Levels on Achieving Cholesterol Targets in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747149
• Other study ID #: D3560L00072
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2008
• Last updated: August 29, 2011
• Start date: May 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Rosuvastatin
Oral

Locations

Country	Name	City	State
Canada	Research Site	Anjou	Quebec
Canada	Research Site	Aylmer	Ontario
Canada	Research Site	Bathurst	New Brunswick
Canada	Research Site	Bolton	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Carbonear	Newfoundland and Labrador
Canada	Research Site	Charlottetown	Prince Edward Island
Canada	Research Site	Chatham	Ontario
Canada	Research Site	Chilliwack	British Columbia
Canada	Research Site	Coquitlam	British Columbia
Canada	Research Site	Delta	British Columbia
Canada	Research Site	Dolbeau-mistassini	Quebec
Canada	Research Site	Drummondville	Quebec
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Forestville	Quebec
Canada	Research Site	Fort Erie	Ontario
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Georgetown	Ontario
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Joliette	Quebec
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Kensington	Prince Edward Island
Canada	Research Site	Kentville	Nova Scotia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Kitchener	Ontario
Canada	Research Site	L'ile- Perrot	Quebec
Canada	Research Site	La Sarre	Quebec
Canada	Research Site	Laval	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Longueuil	Quebec
Canada	Research Site	Maple Ridge	British Columbia
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montague	Prince Edward Island
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Moose Jaw	Saskatchewan
Canada	Research Site	Morrisburg	Ontario
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Nepean	Ontario
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	North York	Ontario
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Penticton	British Columbia
Canada	Research Site	Porcupine Plain	Saskatchewan
Canada	Research Site	Portage La Prairie	Manitoba
Canada	Research Site	Pubnico	Nova Scotia
Canada	Research Site	Quebec
Canada	Research Site	Red Deer	Alberta
Canada	Research Site	Roberval	Quebec
Canada	Research Site	Roxton Pond	Quebec
Canada	Research Site	Saint-bruno-lac-saint-jean	Quebec
Canada	Research Site	Saint-charles-borromee	Quebec
Canada	Research Site	Saint-leonard	Quebec
Canada	Research Site	Saint-marc-des-carrieres	Quebec
Canada	Research Site	Saint-pie	Quebec
Canada	Research Site	Sainte Gedeon-de-beauce	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Scaborough	Ontario
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Smith Falls	Ontario
Canada	Research Site	Spruce Grove	Alberta
Canada	Research Site	St Albert	Alberta
Canada	Research Site	St Catherines	Ontario
Canada	Research Site	St John's	Newfoundland and Labrador
Canada	Research Site	St. Catharines	Ontario
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Sydney Mines	Nova Scotia
Canada	Research Site	Thetford Mines	Quebec
Canada	Research Site	Thornhill	Ontario
Canada	Research Site	Thorold	Ontario
Canada	Research Site	Thunder Bay	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois-rivieres	Quebec
Canada	Research Site	Truro	Nova Scotia
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Welland	Ontario
Canada	Research Site	Willowdale	Ontario
Canada	Research Site	Windsor	Ontario
Canada	Research Site	Winnipeg	Manitoba
Canada	Research Site	Woodstock	New Brunswick
Canada	Research Site	Woodstock	Ontario
Canada	Research Site	Yorkton	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 Weeks	No
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	6 and 12 Weeks	No
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		6 and 12 Weeks	No
Secondary	Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12		6 and 12 Weeks	No
Secondary	Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy		6 and 12 Weeks	No