Diabetes MellitusPhase 2PLANET 1NCT00296374
Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
A Phase 2 study testing Rosuvastatin and Atorvastatin in people with Diabetes Mellitus, run by AstraZeneca at 116 sites in 11 countries.
Trial summary
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Rosuvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 116 sitesin 11 countries
- Study dates
- Feb 2006to Mar 2009
- Phase
- Phase 2
- 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
- hyperlipidemia
- urinary protein
- diabetes
Who cannot join
- previous rosuvastatin treatment < 6 months prior to Visit 1
- statin intolerance
- severe hypertension
Trial locations and contacts
116 sites in 11 countries.
116 sites in 11 countries
United States29 sites
Research Site
Augusta, Georgia
Research Site
Avondale, Arizona
Research Site
Cincinnati, Ohio
Research Site
Columbia, Missouri
Research Site
Columbia, South Carolina
Research Site
Dallas, Texas
Research Site
Detroit, Michigan
Research Site
Hollywood, Florida
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Jonesboro, Arkansas
Research Site
Kettering, Ohio
Research Site
Lubbock, Texas
Research Site
Milwaukee, Wisconsin
Research Site
Ogden, Utah
Research Site
Orchard Park, New York
Research Site
Pasadena, California
Research Site
Phoenix, Arizona
Research Site
Pittsburgh, Pennsylvania
Research Site
Riverside, California
Research Site
San Antonio, Texas
Research Site
Santa Ana, California
Research Site
Springfield, Massachusetts
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St Louis, Missouri
Research Site
Stony Brook, New York
Research Site
Topeka, Kansas
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West Hills, California
Research Site
West Palm Beach, Florida
Research Site
Winston-Salem, North Carolina
Hungary16 sites
Research Site
Baja
Research Site
Balatonfüred
Research site
Budapest
Research Site
Debrecen
Research Site
Győr
Research site
Gyula
Research Site
Hodmeztvasarhely
Research Site
Kecskemét
Research Site
Keszthely
Research Site
Miskolc
Research Site
Mosonmagyaróvár
Research Site
Nyíregyháza
Research Site
Székesfehérvár
Research Site
Szolnok
Research Site
Tatabánya
Research Site
Zalaegerszeg
France13 sites
Research Site
Annonay
Research Site
Besançon
Research Site
Bondy
Research Site
Colmar
Research Site
Corbeil-Essonnes
Research Site
Corsept
Research Site
Creil
Research Site
Grenoble
Research Site
La Chapelle-sur-Erdre
Research Site
Nantes
Research Site
Paris
Research Site
Pessac
Research Site
Quimper
Canada10 sites
Research Site
Courtice, Ontario
Research Site
Greenfield Park, Quebec
Research Site
Montreal, Quebec
Research Site
North York, Ontario
Research Site
Oshawa, Ontario
Research Site
Ottawa, Ontario
Research Site
Richmond Hill, Ontario
Research Site
Scarborough Village, Ontario
Research Site
Thunder Bay, Ontario
Research Site
Vancouver, British Columbia
Italy10 sites
Research Site
Acireale, CT
Research Site
Bergamo
Research Site
Cagliari
Research Site
Florence, FI
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Milan
Research Site
Roma, RM
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San Giovanni Rotondo
Research Site
Sassari
Research Site
Sottomarnia Di Chioggia, VE
Research Site
Treviglio
Mexico8 sites
Research Site
Aguascalientes
Research Site
Cauntla
Research Site
Distrito Federal
Research Site
Durango
Research Site
Guadalajara
Research Site
Saltillo
Research Site
San Luis Potosí City
Research Site
Zapopan
Bulgaria7 sites
Research Site
Burgas
Research Site
Gabrovo
Research Site
Pleven
Research Site
Plovdiv
Research Site
Sofia
Research Site
Varna
Research Site
Veliko Tarnovo
Denmark7 sites
Research Site
Aalborg
Research Site
Blegdamsvej 9
Research Site
Farsø
Research Site
Gentofte Municipality
Research Site
Hillerød
Research Site
Hvidovre
Research Site
Køge
Romania7 sites
Research Site
Baia Mare
Research Site
Brasov
Research Site
Bucharest
Research Site
Craiova
Research Site
Lasi
Research Site
Târgu Mureş
Research Site
Timișoara
Brazil5 sites
Research Site
Curitiba
Research Site
Fortaleza
Research Site
Goiânia
Research Site
Recife
Research Site
São Paulo
Argentina4 sites
Research Site
Buenos Aires
Reasearch Site
La Plata
Research Site
Morón
Research Site
Quilmes
About this study
Official title: Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.
- Conditions
- Diabetes Mellitus
- Being tested
- Rosuvastatin, Atorvastatin
- Keywords
- Hyperlipidemia, Proteinuria, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Hyperlipidemias, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
10 mg oral dose administered once daily for 52 weeks
RosuvastatinDrug
Also called Crestor
20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks
AtorvastatinDrug
Also called Lipitor
40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rosuvastatin 10 mg Receives: Drug: Rosuvastatin |
| 2 | Experimental | Rosuvastatin 40 mg Receives: Drug: Rosuvastatin |
| 3 | Active comparator | Atorvastatin 80 mg Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Measured: Assessed at Week 52, Last observation carried forward (LOCF)
Secondary outcomes (71)
Urinary Protein/Creatinine Ratio at Week 26.
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
Measured: Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 26
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 26 urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
Measured: Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Urinary albumin/creatinine ratio (mg/g) =urine albumin concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine albumin/creatinine ratio over baseline urine albumin/creatinine ratio.
Measured: Assessed at Week 52 LOCF
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
Measured: Assessed at Baseline and Week 26
Change From Baseline in eGFR at Week 52 [LOCF]
Measured: Assessed at Baseline and Week 52 [LOCF]
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52 (LOCF).
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: Assessed at 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary protein/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in urinary albumin/creatinine ratio with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TG
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 26.
Measured: 26 weeks
Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio
Correlation of changes from baseline in eGFR with percent change from baseline in lipids and lipoprotein concentrations at Week 52
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2009
- Study completionMar 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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Crestor Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296374
- Sponsor's protocol ID
- D3569C00007
- Other IDs
- PLANET 1
- Acronym
- PLANET 1
- Status last verified
- Aug 2011
- First submitted
- 23 Feb 2006
- Last updated
- 1 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PubMed 38018702de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.
PubMed 25660356
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, 52-wk, Parallel-grp, Multicentre, PIIb Study to Evaluate Effects of Rosuvastatin 10mg, Rosuvastatin 40mg and Atorvastatin 80mg on Urinary Protein Excretion in Hypercholesterolaemic Diabetic Patients With Moderate Proteinuria
- ClinicalTrials.gov ID
- NCT00296374
- Acronym / sponsor ID
- PLANET 1 / D3569C00007
- Conditions
- Diabetes Mellitus
- Keywords
- Hyperlipidemia, Proteinuria, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Feb 2006 (estimated)
- Results
- Posted 30 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RosuvastatinRosuvastatin 10 mg |
| 2 | Experimental | Drug: RosuvastatinRosuvastatin 40 mg |
| 3 | Active comparator | Drug: AtorvastatinAtorvastatin 80 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hyperlipidemia
- urinary protein
- diabetes
Key exclusion criteria (3 listed)
- previous rosuvastatin treatment < 6 months prior to Visit 1
- statin intolerance
- severe hypertension
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: Crestor10 mg oral dose administered once daily for 52 weeks | Drug | 1 |
| RosuvastatinAlso: Crestor20 mg oral dose administered once daily for 4 weeks followed by 40 mg oral dose administered once daily for 48 weeks | Drug | 2 |
| AtorvastatinAlso: Lipitor40 mg oral dose administered once daily for 4 weeks followed by 80 mg oral dose administered once daily for 48 weeks | Drug | 3 |
Primary outcome
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes.
Time frame: Assessed at Week 52, Last observation carried forward (LOCF)
Urinary protein/creatinine ratio (mg/g) =urine protein concentration (mg/dL)/ urine creatinine concentration (g/dL). Outcome measure is the ratio of Week 52 [LOCF] urine protein/creatinine ratio over baseline urine protein/creatinine ratio.
71 secondary outcomes
Urinary Protein/Creatinine Ratio at Week 26.
Time frame: Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 26
Time frame: Assessed at Week 26
Urinary Albumin/Creatinine Ratio at Week 52 [LOCF]
Time frame: Assessed at Week 52 LOCF
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26
Time frame: Assessed at Baseline and Week 26
Change From Baseline in eGFR at Week 52 [LOCF]
Time frame: Assessed at Baseline and Week 52 [LOCF]
Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes
Time frame: 52 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC
Time frame: Assessed at 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C]
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C]
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C]
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG]
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1]
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB]
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Time frame: 26 weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio
Time frame: 52 Weeks
Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38018702Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
- Derived from this study: PubMed 25660356de Zeeuw D, Anzalone DA, Cain VA, Cressman MD, Heerspink HJ, Molitoris BA, Monyak JT, Parving HH, Remuzzi G, Sowers JR, Vidt DG. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I): a randomised clinical trial. Lancet Diabetes Endocrinol. 2015 Mar;3(3):181-90. doi: 10.1016/S2213-8587(14)70246-3. Epub 2015 Feb 4.
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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.
AstraZeneca Crestor Medical Science Director, MD study director
AstraZeneca
116 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosuvastatin and Atorvastatin in people with Diabetes Mellitus, run by AstraZeneca at 116 sites in 11 countries.
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 3 inclusion and 3 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 1 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 116 sites in United States, Hungary, France, Canada, Italy and 6 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Dec 2010). 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?
Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. (time frame: Assessed at Week 52, Last observation carried forward (LOCF)). 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 NCT00296374, which also lists 2 linked publications.
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 1 Sep 2011.