Type 2 DiabetesPhase 4ADAPTNCT00747149

A Diabetes Study to Treat A Population Previously Not at Target

A Phase 4 study testing Rosuvastatin in people with Type 2 Diabetes, run by AstraZeneca at 84 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Rosuvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 598 participants
Where: 84 sitesCanada
Study dates: May 2008to Aug 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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).

Trial locations and contacts

84 sites in 1 country.

City, postcode or hospital

84 sites in 1 country

Canada84 sites

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

Other trials in Canada

About this study

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

Conditions: Type 2 Diabetes
Being tested: Rosuvastatin
Keywords: diabetes, type 2
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinDrug
Also called Crestor
Oral

Study groups in NCT00747149
Study group	Role	What they receive
Rosuvastatin 1	Experimental	titrated Receives: Drug: Rosuvastatin
Rosuvastatin 2	Experimental	Non-titrated Receives: Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
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
Measured: 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
Measured: 6 and 12 Weeks
Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12
Measured: 6 and 12 Weeks
Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy
Measured: 6 and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Aug 2009

First posted4 Sep 2008 (estimated)
Study startMay 2008
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 598 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00747149
Sponsor's protocol ID: D3560L00072
Acronym: ADAPT
Status last verified: Aug 2011
First submitted: 2 Sep 2008
Last updated: 31 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00747149
Acronym / sponsor ID: ADAPT / D3560L00072
Conditions: Type 2 Diabetes
Keywords: diabetes, type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 598 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 4 Sep 2008 (estimated)
Results: Posted 4 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rosuvastatin 1	Experimental	Drug: Rosuvastatintitrated
Rosuvastatin 2	Experimental	Drug: RosuvastatinNon-titrated

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosuvastatinAlso: CrestorOral	Drug	Rosuvastatin 1, Rosuvastatin 2

Primary outcome

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
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

4 secondary outcomes

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
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
Mean High Sensitivity C-reactive Protein (hsCRP) Value at Week 6 and 12
Time frame: 6 and 12 Weeks
Incidence of Adverse Events and Abnormal Laboratory Values After 12 Weeks of Therapy
Time frame: 6 and 12 Weeks

Results and safety

Results posted to the registry on 4 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosuvastatin Titrated	154	153
Rosuvastatin Non-titrated	444	401

Primary outcome: 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. Mean (95% Confidence Interval). Unit: Percentage

Measure	Rosuvastatin 10 mg (Initial) n = 225	Rosuvastatin 20 mg (Initial) n = 176	Rosuvastatin 20 mg (Titrated) n = 75	Rosuvastatin 40 mg (Titrated) n = 78
Value	87 (82)	87 (81)	76 (65)	63 (52)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosuvastatin 10 mg (Initial)	4 of 319 (1.3%)	14 of 319 (4.4%)	Not reported
Rosuvastatin 10 mg (Continued, Non-titrated)	2 of 232 (0.9%)	4 of 232 (1.7%)	Not reported
Rosuvastatin 20 mg (Initial)	0 of 279 (0%)	9 of 279 (3.2%)	Not reported
Rosuvastatin 20 mg (Continued, Non-titrated)	0 of 182 (0%)	3 of 182 (1.6%)	Not reported
Rosuvastatin 20 mg (Titrated)	1 of 75 (1.3%)	2 of 75 (2.7%)	Not reported
Rosuvastatin 40 mg (Titrated)	1 of 78 (1.3%)	0 of 78 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Davide Meani study director

AstraZeneca

David Lau, MD principal investigator

Private Practice

84 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rosuvastatin in people with Type 2 Diabetes, run by AstraZeneca at 84 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00747149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.