Phase 2
N=353
Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00296374 ↗Enrolled (actual)
353
Serious AEs
16.9%
Results posted
Dec 2010
Primary outcome: Primary: Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. — 1.016; 0.955; 0.874 mg/g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rosuvastatin (Drug); Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes. |
1.016; 0.955; 0.874 | — |
| SECONDARY Urinary Protein/Creatinine Ratio at Week 26. |
1.007; 0.994; 0.876 | — |
| SECONDARY Urinary Albumin/Creatinine Ratio at Week 26 |
0.927; 0.913; 0.831 | — |
| SECONDARY Urinary Albumin/Creatinine Ratio at Week 52 [LOCF] |
1.016; 0.836; 0.823 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 26 |
-2.73; -5.46; -1.78 | — |
| SECONDARY Change From Baseline in eGFR at Week 52 [LOCF] |
-3.70; -7.29; -1.61 | — |
| SECONDARY Correlation Coefficient Urinary Protein/Creatinine Ratio and Total Cholesterol [TC] Indicating the Relationship Between Renal Effects and Lipid Changes |
-0.03507; 0.14258; 0.01600 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio TC |
0.07019; 0.26855; 0.12013 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Low Density Lipoprotein Cholesterol [LDL-C] |
-0.08588; 0.18570; -0.02491 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C |
0.04510; 0.16280; 0.06739 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and High Density Lipoprotein Cholesterol [HDL-C] |
0.15614; 0.06987; 0.14226 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and HDL-C |
0.16111; 0.26194; 0.18918 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Non-high Density Lipoprotein Cholesterol [nonHDL-C] |
-0.12068; 0.15929; -0.05186 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C |
0.02594; 0.24018; 0.07381 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Triglyceride [TG] |
-0.14569; 0.04948; -0.08471 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TG |
-0.05251; 0.11755; 0.01345 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio |
-0.05945; 0.12132; -0.02666 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and TC/HDL-C Ratio |
-0.05945; 0.12132; -0.02666 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio |
-0.02775; 0.06535; -0.01569 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and LDL-C/HDL-C Ratio |
-0.02775; 0.06535; -0.01569 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
-0.06085; 0.12507; -0.02841 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
-0.06085; 0.12507; -0.02841 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein A-1 [ApoA-1] |
0.15859; 0.13133; 0.15516 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoA-1 |
0.16587; 0.18469; 0.18832 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and Apolipoprotein B [ApoB] |
-0.02276; 0.21405; 0.04578 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB |
0.05397; 0.29486; 0.11079 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio |
0.00600; 0.22710; 0.03684 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Protein/Creatinine Ratio and ApoB/ApoA-1 Ratio |
0.00600; 0.22710; 0.03684 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC |
0.13220; 0.35715; 0.18971 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC |
0.13220; 0.35715; 0.18971 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C |
0.10037; 0.21205; 0.12270 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C |
0.10037; 0.21205; 0.12270 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C |
0.14758; 0.26805; 0.17550 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and HDL-C |
0.14758; 0.26805; 0.17550 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C |
0.09189; 0.33769; 0.14988 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C |
0.09189; 0.33769; 0.14988 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG |
-0.02947; 0.27198; 0.08787 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TG |
-0.02947; 0.27198; 0.08787 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio |
0.01798; 0.20127; 0.05369 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and TC/HDL-C Ratio |
0.01798; 0.20127; 0.05369 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio |
0.03476; 0.10902; 0.04508 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and LDL-C/HDL-C Ratio |
0.03476; 0.10902; 0.04508 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
0.01528; 0.21198; 0.05251 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and nonHDL-C/HDL-C Ratio |
0.01528; 0.21198; 0.05251 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 |
0.16085; 0.15933; 0.17306 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoA-1 |
0.16085; 0.15933; 0.17306 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB |
0.10997; 0.30537; 0.15652 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB |
0.10997; 0.30537; 0.15652 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio |
0.04760; 0.25636; 0.07766 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: Urinary Albumin/Creatinine Ratio and ApoB/ApoA-1 Ratio |
0.04760; 0.25636; 0.07766 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and TC |
-0.13489; -0.18105; -0.14690 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and TC |
-0.13489; -0.18105; -0.14690 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C |
-0.11072; -0.12835; -0.11378 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C |
-0.11072; -0.12835; -0.11378 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C |
0.14457; -0.15546; 0.08841 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and HDL-C |
0.14457; -0.15546; 0.08841 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C |
-0.17729; -0.19501; -0.17911 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C |
-0.17729; -0.19501; -0.17911 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and TG |
-0.24494; -0.07059; -0.15586 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and TG |
-0.24494; -0.07059; -0.15586 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio |
-0.26268; -0.08593; -0.23226 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and TC/HDL-C Ratio |
-0.26268; -0.08593; -0.23226 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio |
-0.19850; -0.06481; -0.17579 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and LDL-C/HDL-C Ratio |
-0.19850; -0.06481; -0.17579 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio |
-0.26802; -0.11804; -0.24204 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and nonHDL-C/HDL-C Ratio |
-0.26802; -0.11804; -0.24204 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 |
0.17909; 0.08090; 0.12787 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and ApoA1 |
0.17909; 0.08090; 0.12787 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB |
-0.15146; 0.04886; -0.12168 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB |
-0.15146; 0.04886; -0.12168 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio |
-0.26146; 0.05248; -0.22109 | — |
| SECONDARY Relationship Between Renal Effects and Lipid Changes: eGFR and ApoB/ApoA-1 Ratio |
-0.26146; 0.05248; -0.22109 | — |
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.
Eligibility Criteria
Inclusion Criteria
- hyperlipidemia
- urinary protein
- diabetes
Exclusion Criteria
- previous rosuvastatin treatment < 6 months prior to Visit 1
- statin intolerance
- severe hypertension
Data sourced from ClinicalTrials.gov (NCT00296374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.