Pioglitazone and Losartan Provides Additional Renoprotection

Type 2 Diabetes Clinical Trial

Official title:

Combination Therapy With Pioglitazone and Losartan Provides Additional Renoprotection in Subjects With Type 2 Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364988
• Other study ID #: PLAN
• Status: Completed
• Phase: N/A
• First received: August 14, 2006
• Last updated: October 23, 2014
• Start date: January 2005
• Est. completion date: January 2006

Study information

• Verified date: October 2014
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Years to 75 Years

Eligibility

Inclusion Criteria:

• Fasting plasma glucose (FPG) level of 3.3-9.0mmol/L

• 2h plasma glucose level of 7.5-13 mmol/L

• serum creatinine values between 190 and 660umol/L

• Two occasions of a ratio of urinary albumin to urinary creatinine=300 or 24 hours urinary protein concentration is >150mg

• Informed consent

Exclusion Criteria:

• Type1 diabetes or nondiabetic renal disease

• abnormal liver function

• heart dysfunction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• pioglitazone+losartan
Pioglitazone (30 mg/daily) losartan (100 mg daily)
• losartan
losartan (100 mg daily)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal function	fasting glucose, HbA 1c , Scr, 24-hour urinary protein excretion, and endogenous creatinine clearance (Ccr)	12 month	Yes