A Diabetes Study to Treat A Population Previously Not at Target

NCT00747149 | Completed Phase 4 Results DMC

• 1 other identifier: D3560L00072
• Study Type: interventional
• Target: 598
• Locations: 1 country
• Sites: 84

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.

Conditions

Type 2 Diabetes

Keywords

diabetes; type 2

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

Rosuvastatin 1

EXPERIMENTAL

titrated

Drug: Rosuvastatin

Rosuvastatin 2

EXPERIMENTAL

Non-titrated

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Oral

Also known as: Crestor

Rosuvastatin 1; Rosuvastatin 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (84)

Research Site

Calgary, Alberta, Canada

Location

Research Site

Edmonton, Alberta, Canada

Location

Research Site

Red Deer, Alberta, Canada

Location

Research Site

Spruce Grove, Alberta, Canada

Location

Research Site

St. Albert, Alberta, Canada

Location

Research Site

Chilliwack, British Columbia, Canada

Location

Research Site

Coquitlam, British Columbia, Canada

Location

Research Site

Delta, British Columbia, Canada

Location

Research Site

Kelowna, British Columbia, Canada

Location

Research Site

Maple Ridge, British Columbia, Canada

Location

Research Site

Penticton, British Columbia, Canada

Location

Research Site

Victoria, British Columbia, Canada

Location

Research Site

Portage la Prairie, Manitoba, Canada

Location

Research Site

Winnipeg, Manitoba, Canada

Location

Research Site

Bathurst, New Brunswick, Canada

Location

Research Site

Woodstock, New Brunswick, Canada

Location

Research Site

Carbonear, Newfoundland and Labrador, Canada

Location

Research Site

Mount Pearl, Newfoundland and Labrador, Canada

Location

Research Site

St. John's, Newfoundland and Labrador, Canada

Location

Research Site

Halifax, Nova Scotia, Canada

Location

Research Site

Kentville, Nova Scotia, Canada

Location

Research Site

Pubnico, Nova Scotia, Canada

Location

Research Site

Sydney Mines, Nova Scotia, Canada

Location

Research Site

Truro, Nova Scotia, Canada

Location

Research Site

Aylmer, Ontario, Canada

Location

Research Site

Bolton, Ontario, Canada

Location

Research Site

Chatham, Ontario, Canada

Location

Research Site

Fort Erie, Ontario, Canada

Location

Research Site

Georgetown, Ontario, Canada

Location

Research Site

Greater Sudbury, Ontario, Canada

Location

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Kingston, Ontario, Canada

Location

Research Site

Kitchener, Ontario, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

Mississauga, Ontario, Canada

Location

Research Site

Morrisburg, Ontario, Canada

Location

Research Site

Nepean, Ontario, Canada

Location

Research Site

Newmarket, Ontario, Canada

Location

Research Site

North York, Ontario, Canada

Location

Research Site

Oshawa, Ontario, Canada

Location

Research Site

Ottawa, Ontario, Canada

Location

Research Site

Saint Catherines, Ontario, Canada

Location

Research Site

Scaborough, Ontario, Canada

Location

Research Site

Scarborough Village, Ontario, Canada

Location

Research Site

Smith Falls, Ontario, Canada

Location

Research Site

St. Catharines, Ontario, Canada

Location

Research Site

Thornhill, Ontario, Canada

Location

Research Site

Thorold, Ontario, Canada

Location

Research Site

Thunder Bay, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Welland, Ontario, Canada

Location

Research Site

Willowdale, Ontario, Canada

Location

Research Site

Windsor, Ontario, Canada

Location

Research Site

Woodstock, Ontario, Canada

Location

Research Site

Charlottetown, Prince Edward Island, Canada

Location

Research Site

Kensington, Prince Edward Island, Canada

Location

Research Site

Montague, Prince Edward Island, Canada

Location

Research Site

Anjou, Quebec, Canada

Location

Research Site

Dolbeau-Mistassini, Quebec, Canada

Location

Research Site

Drummondville, Quebec, Canada

Location

Research Site

Forestville, Quebec, Canada

Location

Research Site

Gatineau, Quebec, Canada

Location

Research Site

Joliette, Quebec, Canada

Location

Research Site

L'Ile Perrot, Quebec, Canada

Location

Research Site

La Sarre, Quebec, Canada

Location

Research Site

Laval, Quebec, Canada

Location

Research Site

Longueuil, Quebec, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Roberval, Quebec, Canada

Location

Research Site

Roxton Pond, Quebec, Canada

Location

Research Site

Saint-bruno-lac-saint-jean, Quebec, Canada

Location

Research Site

Saint-Charles-Borromée, Quebec, Canada

Location

Research Site

Saint-Léonard, Quebec, Canada

Location

Research Site

Saint-Marc-des-Carrieres, Quebec, Canada

Location

Research Site

Saint-Pie, Quebec, Canada

Location

Research Site

Sainte Gedeon-de-beauce, Quebec, Canada

Location

Research Site

Sherbrooke, Quebec, Canada

Location

Research Site

Thetford-Mines, Quebec, Canada

Location

Research Site

Trois-Rivières, Quebec, Canada

Location

Research Site

Moose Jaw, Saskatchewan, Canada

Location

Research Site

Porcupine Plain, Saskatchewan, Canada

Location

Research Site

Saskatoon, Saskatchewan, Canada

Location

Research Site

Yorkton, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Davide Meani

  AstraZeneca

  STUDY DIRECTOR

• David Lau, MD

  Private Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 31, 2011
• Results First Posted: July 4, 2011

Record last verified: 2011-08

Locations

CA (84)