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Diabetes Mellitus, Type 2Phase 1/2NCT00464776

Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Patients With Type 2 Diabetes and Incipient or Overt Nephropathy

A Phase 1/2 study testing Aliskiren in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2 diabetes patients with incipient or overt nephropathy Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Aliskiren
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteDenmark
Study dates
Oct 2005to Apr 2008
Phase
Phase 1/2
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and/or female patients from 30-80 years of age.
  • Type 2 diabetes (defined using World Health Organization criteria)
  • Incipient or overt nephropathy (urinary albumin excretion 100 but ≤ 2000 mg/day).
  • Glomerular filtration rate (GFR) 40ml per minute
  • To be eligible for randomization, patients must fulfill the following criteria:
  • Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (Run-in period)
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  • Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1)
  • Female patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening
  • Oral body temperature within the range 35.0-37.5 °C
  • Able to provide written informed consent prior to study participation.
  • Able to communicate well with the investigator and comply with the requirements of the study.
  • Patients must be willing and medically able to discontinue anti-hypertensive treatment or any other medication which is prohibited in the study protocol.
  • Patients must be on stable hypoglycemic medications for at least 8 weeks prior to visit 1 (Screening visit).

Who cannot join

  • Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
  • Severe Hypertension Grade 3 WHO classification Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg)
  • Acetylsalicyclic acid (ASA) treatment >1g/day or regular use of Non steroidal anti-inflammatory drugs (NSAIDs)
  • Kidney disease not caused by diabetes or hypertension
  • Serum potassium < 3.5 or > 5.1 mEq/L
  • GFR < 40 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula
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  • Serum albumin < 2.0mg/dL
  • History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit 1
  • Transient ischemic cerebral attack during the 6 months prior to Visit 1
  • Current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV
  • History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
  • Second or third degree heart block without a pacemaker
  • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
  • Clinically significant valvular heart disease
  • Type 1 diabetes mellitus
  • Uncontrolled Type II diabetes mellitus Hemoglobin subtype A1C (HbA1C) >11 %
  • History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
  • Pregnant or nursing women
  • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
  • Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
  • Significant illness within the two weeks prior to dosing.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
  • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
  • Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1
  • Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
  • Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
  • Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
  • Current treatment with cholestyramine or cholestipol resins
  • History of immunocompromise, including a positive HIV test result.
  • History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
  • History of drug or alcohol abuse within the 12 months prior to dosing.
  • Persons directly involved in the execution of this protocol.
  • Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol
  • Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drug
  • Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
  • Patients who previously participated in any Aliskiren study.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Novartis

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

Official title: A Randomized, Double-blind, Cross-over, 4-period, 4 Treatment, Within-subject Placebo-controlled Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Type 2 Diabetic Patients With Incipient or Overt Nephropathy

This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2 diabetes patients with incipient or overt nephropathy

Being tested
Aliskiren
Keywords
Randomized, double-blind, cross-over, 4-period, 4 treatment, within-subject placebo-controlled study, assess optimal renoprotective dose of Aliskiren, hypertensive type 2 diabetes patients, incipient or overt nephropathy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AliskirenDrug

    Also called SPP100

  • AliskirenDrug

    Also called SPP100

  • AliskirenDrug

    Also called SPP100

  • AliskirenDrug

    Also called SPP100

Study groups in NCT00464776
Study groupRoleWhat they receive
1ExperimentalVarious sequences of 3 doses of Aliskiren plus placebo
Receives: Drug: Aliskiren
2ExperimentalVarious sequences of 3 doses of Aliskiren plus placebo
Receives: Drug: Aliskiren
3ExperimentalVarious sequences of 3 doses of Aliskiren plus placebo
Receives: Drug: Aliskiren
4ExperimentalVarious sequences of 3 doses of Aliskiren plus placebo
Receives: Drug: Aliskiren

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigate the antiproteinuric effect of increasing doses of Aliskiren compared to matching placebo.

    Measured: End of study

Secondary outcomes (3)

  1. Assess the effect on Glomerular Filtration Rate (GFR) of multiple dose administration of Aliskiren.

    Measured: End of study

  2. Assess the effect on blood pressure of multiple dose administration of Aliskiren.

    Measured: End of study

  3. To investigate whether there is a change in biomarkers of inflammation and cardiovascular risk.

    Measured: End of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2007 (estimated)
  2. Study startOct 2005
  3. Primary completionApr 2008

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00464776
Sponsor's protocol ID
CSPP100A2240
Status last verified
Feb 2011
First submitted
21 Apr 2007
Last updated
4 Feb 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Persson F, Rossing P, Reinhard H, Juhl T, Stehouwer CD, Schalkwijk C, Danser AH, Boomsma F, Frandsen E, Parving HH. Optimal antiproteinuric dose of aliskiren in type 2 diabetes mellitus: a randomised crossover trial. Diabetologia. 2010 Aug;53(8):1576-80. doi: 10.1007/s00125-010-1789-6. Epub 2010 May 18.

    PubMed 20480132

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Aliskiren in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in Denmark.

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 13 inclusion and 38 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: finished, as of the sponsor's last update on 4 Feb 2011. 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 Denmark. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Investigate the antiproteinuric effect of increasing doses of Aliskiren compared to matching placebo. (time frame: End of study). 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 NCT00464776, which also lists 1 linked publication.

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 4 Feb 2011.

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