Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253786
• Other study ID #: DNETT-Japan
• Status: Completed
• Phase: N/A
• Start date: November 11, 2005
• Est. completion date: November 27, 2014

Study information

• Verified date: July 2019
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy

Description:

Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: November 27, 2014
• Est. primary completion date: November 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients with type 2 diabetes

2. Urinary albumin-to-creatinine ratio: >=300 mg/g creatinine twice in the first morning urine sample

3. Serum creatinine level: =<2.5 mg/dl

4. Patients aged 20-75 years

Exclusion Criteria:

1. Type 1 diabetes

2. Hereditary diabetes or secondary diabetes

3. Non-diabetic nephropathy

4. Familial hypercholesterolemia

5. Secondary hypertension

6. Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition

7. Malignant tumor or life threatening disease

8. History of angioedema

9. Patients undergoing LDL apheresis

10. Biliary system obstruction or severe liver injury

11. Liver dysfunction

12. Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors

13. Pregnant or nursing patients

14. Others: patients who are not suitable for this trial

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Type 2 Diabetes Mellitus

Intervention

Other:
• Intensive multifactorial therapy
Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care
• Standard therapy
Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)

Locations

Country	Name	City	State
Japan	Okayama University Hospital	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A		5 years
Primary	Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B		5 years
Secondary	GFR in Protocol A		5 years
Secondary	Cardiovascular event in Protocol A		5 years
Secondary	Progression of retinopathy in Protocol A		5 years
Secondary	Urinary albumin/creatinine ratio in Protocol A		5 years
Secondary	Proteinuria (24 h collection sample) in Protocol A		5 years
Secondary	GFR in Protocol B		5 years
Secondary	Cardiovascular event in Protocol B		5 years
Secondary	Progression of retinopathy in Protocol B		5 years
Secondary	Urinary albumin/creatinine ratio in Protocol B		5 years
Secondary	Urinary protein/creatinine ratio in Protocol B		5 years