Clinical trial NCT00747149: A Diabetes Study to Treat A Population Previously Not at Target
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: diabetes
type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 598
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: 12 Weeks
Secondary outcomes:
measure: 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
timeFrame: 6 and 12 Weeks
measure: 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
timeFrame: 6 and 12 Weeks
measure: Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12
timeFrame: 6 and 12 Weeks
measure: Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy
timeFrame: 6 and 12 Weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Red Deer
country: Canada
facility: Research Site
state: Alberta
city: Spruce Grove
country: Canada
facility: Research Site
state: Alberta
city: St Albert
country: Canada
facility: Research Site
state: Alberta
city: Chilliwack
country: Canada
facility: Research Site
state: British Columbia
city: Coquitlam
country: Canada
facility: Research Site
state: British Columbia
city: Delta
country: Canada
facility: Research Site
state: British Columbia
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Maple Ridge
country: Canada
facility: Research Site
state: British Columbia
city: Penticton
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Portage La Prairie
country: Canada
facility: Research Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Bathurst
country: Canada
facility: Research Site
state: New Brunswick
city: Woodstock
country: Canada
facility: Research Site
state: New Brunswick
city: Carbonear
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Mount Pearl
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Kentville
country: Canada
facility: Research Site
state: Nova Scotia
city: Pubnico
country: Canada
facility: Research Site
state: Nova Scotia
city: Sydney Mines
country: Canada
facility: Research Site
state: Nova Scotia
city: Truro
country: Canada
facility: Research Site
state: Nova Scotia
city: Aylmer
country: Canada
facility: Research Site
state: Ontario
city: Bolton
country: Canada
facility: Research Site
state: Ontario
city: Chatham
country: Canada
facility: Research Site
state: Ontario
city: Fort Erie
country: Canada
facility: Research Site
state: Ontario
city: Georgetown
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Kitchener
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Morrisburg
country: Canada
facility: Research Site
state: Ontario
city: Nepean
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Oshawa
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Scaborough
country: Canada
facility: Research Site
state: Ontario
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
city: Smith Falls
country: Canada
facility: Research Site
state: Ontario
city: St Catherines
country: Canada
facility: Research Site
state: Ontario
city: St. Catharines
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Thornhill
country: Canada
facility: Research Site
state: Ontario
city: Thorold
country: Canada
facility: Research Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Welland
country: Canada
facility: Research Site
state: Ontario
city: Willowdale
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Woodstock
country: Canada
facility: Research Site
state: Ontario
city: Charlottetown
country: Canada
facility: Research Site
state: Prince Edward Island
city: Kensington
country: Canada
facility: Research Site
state: Prince Edward Island
city: Montague
country: Canada
facility: Research Site
state: Prince Edward Island
city: Anjou
country: Canada
facility: Research Site
state: Quebec
city: Dolbeau-mistassini
country: Canada
facility: Research Site
state: Quebec
city: Drummondville
country: Canada
facility: Research Site
state: Quebec
city: Forestville
country: Canada
facility: Research Site
state: Quebec
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Joliette
country: Canada
facility: Research Site
state: Quebec
city: L'ile- Perrot
country: Canada
facility: Research Site
state: Quebec
city: La Sarre
country: Canada
facility: Research Site
state: Quebec
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Longueuil
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Roberval
country: Canada
facility: Research Site
state: Quebec
city: Roxton Pond
country: Canada
facility: Research Site
state: Quebec
city: Saint-bruno-lac-saint-jean
country: Canada
facility: Research Site
state: Quebec
city: Saint-charles-borromee
country: Canada
facility: Research Site
state: Quebec
city: Saint-leonard
country: Canada
facility: Research Site
state: Quebec
city: Saint-marc-des-carrieres
country: Canada
facility: Research Site
state: Quebec
city: Saint-pie
country: Canada
facility: Research Site
state: Quebec
city: Sainte Gedeon-de-beauce
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Thetford Mines
country: Canada
facility: Research Site
state: Quebec
city: Trois-rivieres
country: Canada
facility: Research Site
state: Quebec
city: Moose Jaw
country: Canada
facility: Research Site
state: Saskatchewan
city: Porcupine Plain
country: Canada
facility: Research Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Yorkton
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Davide Meani
role: STUDY_DIRECTOR
affiliation: Private Practice
name: David Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: