Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00108485
• Other study ID #: 20043224
• Status: Terminated
• Phase: Phase 3
• First received: April 15, 2005
• Last updated: July 29, 2014
• Start date: April 2005
• Est. completion date: December 2012

Study information

• Verified date: July 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to test the effectiveness and tolerability of Niaspan® to improve the levels of blood fats ("good" and "bad" cholesterol and triglyceride levels) in people who have kidney damage due to diabetes. A secondary goal is to test whether Niaspan® slows down further development of kidney damage.

Description:

Diabetic nephropathy is the leading cause of end stage kidney disease in the United States. Patients with chronic kidney disease have a markedly increased risk of death from cardiovascular disease, and traditional risk factors such as hyperlipidemia have been shown to be of critical importance. Almost 90% of patients with diabetes and chronic kidney disease have lipid abnormalities. Here, we investigate whether Niaspan, taken in addition to lipid-lowering drugs referred to as "statins", will decrease LDL cholesterol and increase LDL particle size, increase HDL, reduce proteinuria, and reduce the speed of loss of renal function.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of type 2 diabetes

• Diagnosis of chronic kidney disease stage 2 or 3 with an estimated GFR of 30-89 ml/min using the four variable MDRD (Modification of Diet in Renal Disease Study Group) formula

• Presence of microalbuminuria or proteinuria less than 3.5 g/d

• Diagnosis of hyperlipidemia currently treated with a "statin" drug

Exclusion Criteria:

• Not meeting inclusion criteria

• HDL-C > 40 mg/dL for men, > 50 mg/dL for women

• TG (triglycerides) < 150 mg/dL and > 800 mg/dL

• Documented intolerance to Niaspan or Aspirin

• Treatment with other lipid-lowering agents (fibrates, BAS [bile acid sequestrants], or ezetimibe)

• Elevated transaminases (AST or ALT >1.3 x ULN)

• Unstable type 2 diabetes (FBG >200 mg/dL or HbA1c >9.5%)

• Known seropositivity for Hepatitis B, C, or HIV

• Documented history of malignancy

• Age < 18 years

• Pregnant women or nursing mothers

• Inability to give informed consent

• Start or change in "statin" dose < 2 months ago

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Hyperlipidemia
• Hyperlipidemias
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Extended release niacin
Extended release niacin 1500-2000mg once daily

Locations

Country	Name	City	State
United States	Univesity of Miami/Diabetes Research Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (5)

Grundy SM, Vega GL, McGovern ME, Tulloch BR, Kendall DM, Fitz-Patrick D, Ganda OP, Rosenson RS, Buse JB, Robertson DD, Sheehan JP; Diabetes Multicenter Research Group. Efficacy, safety, and tolerability of once-daily niacin for the treatment of dyslipidemia associated with type 2 diabetes: results of the assessment of diabetes control and evaluation of the efficacy of niaspan trial. Arch Intern Med. 2002 Jul 22;162(14):1568-76. — View Citation

Guyton JR, Blazing MA, Hagar J, Kashyap ML, Knopp RH, McKenney JM, Nash DT, Nash SD. Extended-release niacin vs gemfibrozil for the treatment of low levels of high-density lipoprotein cholesterol. Niaspan-Gemfibrozil Study Group. Arch Intern Med. 2000 Apr 24;160(8):1177-84. — View Citation

Owada A, Suda S, Hata T. Antiproteinuric effect of niceritrol, a nicotinic acid derivative, in chronic renal disease with hyperlipidemia: a randomized trial. Am J Med. 2003 Apr 1;114(5):347-53. — View Citation

Whitney EJ, Krasuski RA, Personius BE, Michalek JE, Maranian AM, Kolasa MW, Monick E, Brown BG, Gotto AM Jr. A randomized trial of a strategy for increasing high-density lipoprotein cholesterol levels: effects on progression of coronary heart disease and clinical events. Ann Intern Med. 2005 Jan 18;142(2):95-104. — View Citation

Wolfe ML, Vartanian SF, Ross JL, Bansavich LL, Mohler ER 3rd, Meagher E, Friedrich CA, Rader DJ. Safety and effectiveness of Niaspan when added sequentially to a statin for treatment of dyslipidemia. Am J Cardiol. 2001 Feb 15;87(4):476-9, A7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proteinuria		1 year	No
Secondary	Change in LDL (low-density lipoprotein) concentration		1 year	No
Secondary	Change in LDL particle size		1 year	No
Secondary	Change in estimated GFR (glomerular filtration rate)		1 year	No
Secondary	Incidence of adverse events		1 year	Yes
Secondary	Change in HDL-C		1 year	No