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

Primary Purpose

Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Extended release niacin

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia, Randomized Controlled Trials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Univesity of Miami/Diabetes Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Extended release niacin

Placebo

Arm Description

Extended release niacin 1500-2000 mg daily versus placebo comparator

Placebo tablets

Outcomes

Primary Outcome Measures

Change in Proteinuria

Secondary Outcome Measures

Full Information

NCT ID

NCT00108485

First Posted

April 15, 2005

Last Updated

May 17, 2016

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00108485

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

Unable to recruit sufficient study subjects

Study Start Date

April 2005 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia

Keywords

Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia, Randomized Controlled Trials

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Extended release niacin

Arm Type

Active Comparator

Arm Description

Extended release niacin 1500-2000 mg daily versus placebo comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablets

Intervention Type

Drug

Intervention Name(s)

Extended release niacin

Other Intervention Name(s)

Niaspan

Intervention Description

Extended release niacin 1500-2000mg once daily

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets

Primary Outcome Measure Information:

Title

Change in Proteinuria

Time Frame

Baseline, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Goldberg, MD

Organizational Affiliation

University of Miami, Miami, FL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Univesity of Miami/Diabetes Research Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12123399

Citation

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. doi: 10.1001/archinte.162.14.1568.

Results Reference

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PubMed Identifier

11179541

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. doi: 10.1016/s0002-9149(00)01410-7.

Results Reference

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PubMed Identifier

10789612

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. doi: 10.1001/archinte.160.8.1177.

Results Reference

background

PubMed Identifier

15657157

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. doi: 10.7326/0003-4819-142-2-200501180-00008.

Results Reference

background

PubMed Identifier

12714122

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. doi: 10.1016/s0002-9343(02)01567-x.

Results Reference

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

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