Diabetes Mellitus, Type 2Phase 3NCT00108485
Study of the Use of Niaspan for Treatment of Dyslipidemia in Diabetic Nephropathy
A Phase 3 study testing Extended release niacin in people with Diabetes Mellitus, Type 2 and Kidney Failure, Chronic, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia
- What is being tested?
- Extended release niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Univesity of Miami/Diabetes Research Institute
Miami, Florida, 33136
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment
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.
Read the 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.
- Being tested
- Extended release niacin, Placebo
- Keywords
- Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia, Randomized Controlled Trials
- Medical subject headings
- Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended release niacinDrug
Also called Niaspan
Extended release niacin 1500-2000mg once daily
PlaceboOther
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Extended release niacin | Active comparator | Extended release niacin 1500-2000 mg daily versus placebo comparator Receives: Drug: Extended release niacin |
| Placebo | Placebo comparator | Placebo tablets Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proteinuria
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Unable to recruit sufficient study subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Goldberg, University of Miami
- Investigators
- Ronald Goldberg, MD, Principal investigator, University of Miami, Miami, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108485
- Sponsor's protocol ID
- 20043224
- Status last verified
- May 2016
- First submitted
- 15 Apr 2005
- Last updated
- 22 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 12123399Wolfe 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.
PubMed 11179541Guyton 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.
PubMed 10789612Whitney 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.
PubMed 15657157Owada 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.
PubMed 12714122
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial of Niaspan® in Patients With Overt Diabetic Nephropathy and Moderate Renal Impairment
- ClinicalTrials.gov ID
- NCT00108485
- Acronym / sponsor ID
- 20043224
- Keywords
- Diabetes Mellitus, Type 2, Kidney Failure, Chronic, Hyperlipidemia, Randomized Controlled Trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient study subjects
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Apr 2005 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended release niacin | Active comparator | Drug: Extended release niacinExtended release niacin 1500-2000 mg daily versus placebo comparator |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended release niacinAlso: NiaspanExtended release niacin 1500-2000mg once daily | Drug | Extended release niacin |
| PlaceboPlacebo tablets | Other | Placebo |
Primary outcome
Change in Proteinuria
Time frame: Baseline, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12123399Grundy 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.
- Background: PubMed 11179541Wolfe 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.
- Background: PubMed 10789612Guyton 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.
- Background: PubMed 15657157Whitney 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.
- Background: PubMed 12714122Owada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Goldberg, MD principal investigator
University of Miami, Miami, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extended release niacin in people with Diabetes Mellitus, Type 2 and Kidney Failure, Chronic, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proteinuria (time frame: Baseline, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00108485, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016; AzTrials last refreshed its copy on 8 Nov 2026.