A Phase 3 interventional study of Extended release niacin and Placebo in Diabetes Mellitus, Type 2, Kidney Failure, Chronic and Hyperlipidemia, sponsored by University of Miami. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-22.
Sponsored by University of Miami · Phase 3, Interventional, and Treatment
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 9 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Miami is the lead sponsor of 838 studies on the registry; 164 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 96 (84%) have results posted.
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Exclusion Criteria:
Extended release niacin 1500-2000 mg daily versus placebo comparator
Drug: Extended release niacin
Placebo tablets
Other: Placebo
Extended release niacin 1500-2000mg once daily
Also known as: Niaspan
Placebo tablets
Change in Proteinuria
Time frame: Baseline, 1 year
| Milestone | Extended Release Niacin | Placebo |
|---|---|---|
| Started | 5 | 4 |
| Completed | 2 | 2 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 |
| mg/dL | Extended Release Niacin | Placebo |
|---|---|---|
| Change in Proteinuria | 42 | 63 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Extended Release Niacin | — | 0/5 (0%) | 3/5 (60%) |
| Placebo | — | 0/4 (0%) | 3/4 (75%) |
| Event | Extended Release Niacin | Placebo |
|---|---|---|
| BronchitisRespiratory, thoracic and mediastinal disorders | 0/5 | 1/4 |
| Bilateral Calf PainMusculoskeletal and connective tissue disorders | 0/5 | 1/4 |
| DiarrheaGastrointestinal disorders | 0/5 | 1/4 |
| Back and Shoulder PainMusculoskeletal and connective tissue disorders | 0/5 | 1/4 |
| Leg Muscle PainMusculoskeletal and connective tissue disorders | 0/5 | 1/4 |
| Blurred VisionEye disorders | 1/5 | 0/4 |
| Subpleural NoduleVascular disorders | 1/5 | 0/4 |
| FlushingVascular disorders | 1/5 | 0/4 |
| Itching Upper ExtremetiesSkin and subcutaneous tissue disorders | 1/5 | 0/4 |
| Chest PainGeneral disorders | 1/5 | 0/4 |
| Age, Categorical(Participants) | Extended Release Niacin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 2 | 6 |
| >=65 years | 1 | 2 | 3 |
| Sex: Female, Male(Participants) | Extended Release Niacin | Placebo | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 2 | 2 | 4 |
| Region of Enrollment(participants) | Extended Release Niacin | Placebo | Total |
|---|---|---|---|
| United States | 5 | 4 | 9 |
The record gives a start of Apr 2005, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
Results were first posted in May 2016, 3 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Niacin