Diabetic NephropathyPhase 3NCT00004266
Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes
A Phase 3 study testing Lisinopril, Nifedipine and Simvastatin in people with Diabetic Nephropathy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
OBJECTIVES: I. Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community. II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Lisinopril, Nifedipine and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1993to Jul 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Non-insulin-dependent diabetes mellitus with documented fasting hyperglycemia Microalbuminuria OR clinically detectable albuminuria; Urine albumin excretion rate at least 30 mg/24 hours Low-density lipoproteins (fasting) at least 80 mg/dL Recruitment from American Indian population at Red Lake and Leech Lake reservations
--Prior/Concurrent Therapy-- At least 5 days since antihypertensives or antilipemics
--Patient Characteristics-- Renal: Urine albumin-to-creatinine ratio at least 30 mg/g; Creatinine clearance or estimated creatinine clearance at least 30 mL/min; No active urine sediment suggestive of glomerulonephritis, i.e.: No RBCs greater than 10/high-power field; No WBCs greater than 15/high-power field; No RBC casts
Cardiovascular: No symptomatic orthostatic hypotension; No poorly-compensated congestive heart failure; No requirement for angiotensin-converting enzyme inhibitors; No angina pectoris requiring nifedipine; No unstable angina; No episodes of angina occurring more than once a month; No chest pain of undetermined cause within 1 month; No severe hypertension requiring multiple antihypertensives; No myocardial infarction within 1 year; No stroke or transient ischemic attack within 1 year
Other: No known allergy to nifedipine, lisinopril, or simvastatin; No untreated proliferative retinopathy; Documented retinal exam within 1 year prior to entry; No alcohol or drug abuse affecting compliance; No other debilitating or acute illness; No pregnant or nursing women; Effective contraception required of fertile women
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Randomized Study of Antihypertensives and Antilipemics in American Indians With Non-Insulin-Dependent Diabetes Mellitus at High Risk of Developing Nephropathy and Cardiovascular Disease
OBJECTIVES:
- Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community.
II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria.
III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
Read the detailed description
PROTOCOL OUTLINE:
Patients are randomly assigned to 1 of 4 treatment groups; therapy continues for 3 years. All patients receive instruction on diet, exercise, and smoking cessation.
The first group receives daily nifedipine at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
The second group receives daily lisinopril at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
The third group receives daily nifedipine at a dose adjusted for high blood pressure, and simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine may be given as needed. If cholestyramine is not tolerated or if triglycerides are high, gemfibrozil is substituted for cholestyramine.
The fourth group receives lisinopril at a dose adjusted for high blood pressure and simvastatin at a dose adjusted for high low-density lipoproteins.
- Conditions
- Diabetic Nephropathy
- Being tested
- Lisinopril, Nifedipine, Simvastatin
- Keywords
- diabetic nephropathy, rare disease, renal and genitourinary disorders
- Medical subject headings
- Diabetic Nephropathies, Rare Diseases, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LisinoprilDrug
NifedipineDrug
SimvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Experimental | Daily nifedipine at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently. Receives: Drug: Nifedipine |
| Lisinopril | Experimental | Daily lisinopril at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently. Receives: Drug: Lisinopril |
| Nifedipine and simvastatin | Experimental | Daily nifedipine at a dose adjusted for high blood pressure, and simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine may be given as needed. If cholestyramine is not tolerated or if triglycerides are high, gemfibrozil is substituted for cholestyramine. Receives: Drug: Nifedipine; Drug: Simvastatin |
| Lisinopril and simvastatin | Experimental | Lisinopril at a dose adjusted for high blood pressure and simvastatin at a dose adjusted for high low-density lipoproteins. Receives: Drug: Lisinopril; Drug: Simvastatin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startAug 1993
- Primary completionJul 1999
- Study completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Hennepin County Medical Center, Minneapolis
- Responsible party
- Sponsor
- Investigators
- Bertram L. Kasiske, Study chair, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004266
- Sponsor's protocol ID
- 199/11643
- Other IDs
- UMN-1967, R01DK047112
- Status last verified
- Mar 2018
- First submitted
- 18 Oct 1999
- Last updated
- 7 Mar 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Antihypertensives and Antilipemics in American Indians With Non-Insulin-Dependent Diabetes Mellitus at High Risk of Developing Nephropathy and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00004266
- Acronym / sponsor ID
- 199/11643
- Conditions
- Diabetic Nephropathy
- Keywords
- diabetic nephropathy, rare disease, renal and genitourinary disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Hennepin County Medical Center, Minneapolis
- Study start
- Aug 1993 (actual)
- Primary completion
- Jul 1999 (actual)
- Study completion
- Jul 1999 (actual)
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Establish a long-term working relationship between clinical investigators and the Minnesota American Indian community.
II. Compare the effectiveness of lisinopril (an angiotensin-converting enzyme inhibitor) and nifedipine (a calcium channel blocker) in preventing nephropathy and vascular disease in Minnesota American Indians with non-insulin-dependent diabetes mellitus and microalbuminuria.
III. Compare the effectiveness of simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor) with lipid-lowering strategies recommended by the National Cholesterol Education Program in preventing nephropathy and vascular diseases in these patients.
Detailed description
PROTOCOL OUTLINE:
Patients are randomly assigned to 1 of 4 treatment groups; therapy continues for 3 years. All patients receive instruction on diet, exercise, and smoking cessation.
The first group receives daily nifedipine at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
The second group receives daily lisinopril at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently.
The third group receives daily nifedipine at a dose adjusted for high blood pressure, and simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine may be given as needed. If cholestyramine is not tolerated or if triglycerides are high, gemfibrozil is substituted for cholestyramine.
The fourth group receives lisinopril at a dose adjusted for high blood pressure and simvastatin at a dose adjusted for high low-density lipoproteins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Experimental | Drug: NifedipineDaily nifedipine at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently. |
| Lisinopril | Experimental | Drug: LisinoprilDaily lisinopril at a dose adjusted for high blood pressure. Cholestyramine or gemfibrozil is administered per National Cholesterol Education Program guidelines. Diuretics and doxazosin may be given concurrently. |
| Nifedipine and simvastatin | Experimental | Drug: Nifedipine, Drug: SimvastatinDaily nifedipine at a dose adjusted for high blood pressure, and simvastatin at a dose adjusted for high low-density lipoproteins. Supplemental cholestyramine may be given as needed. If cholestyramine is not tolerated or if triglycerides are high, gemfibrozil is substituted for cholestyramine. |
| Lisinopril and simvastatin | Experimental | Drug: Lisinopril, Drug: SimvastatinLisinopril at a dose adjusted for high blood pressure and simvastatin at a dose adjusted for high low-density lipoproteins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Lisinopril | Drug | Lisinopril, Lisinopril and simvastatin |
| Nifedipine | Drug | Nifedipine, Nifedipine and simvastatin |
| Simvastatin | Drug | Lisinopril and simvastatin, Nifedipine and simvastatin |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Related trials for Diabetic Nephropathy
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
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.
Bertram L. Kasiske study chair
Hennepin County Medical Center, Minneapolis
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 Lisinopril, Nifedipine and Simvastatin in people with Diabetic Nephropathy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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?
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: finished, as of the sponsor's last update on 7 Mar 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 7 Mar 2018.