Diabetes Type 2Phase 1/2NCT00461136
Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes
A Phase 1/2 study testing Aliskiren in people with Diabetes Type 2, run by Novartis at 1 site in Denmark.
Trial summary
This study will evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Aliskiren
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2005to Nov 2006
- 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 with a diagnosis of Type 2 diabetes (WHO criteria).
- Incipient and established diabetic nephropathy (urinary albumin excretion ≥ 100 mg/day but ≤ 2000 mg/day).
- Glomerular filtration rate (GFR) ≥ 40 ml/min (estimated using Modification of Diet in Renal Disease (MDRD) formula) in the last 4 months.
- 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.
- To be eligible 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 baseline (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to baseline (Day -1).; Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1).
- Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 ( Day -1).
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- Patients must be willing and medically able to discontinue all Angiotensin-converting enzyme inhibitor (ACEI), Angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study.
- 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.
Who cannot join
- 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 drug (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 MDRD formula
- Serum albumin < 2.0mg/dL
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- History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit1.
- 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 (Hemaglobin subtype A1C (HbA1C) >11 %)
- History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
- 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 Angiotensin converting enzyme (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
- Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
- Patients who previously participated in any Aliskiren study.
- Pregnant or nursing woman.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, One-period, One-treatment Study to Evaluate the Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes Suffering From Incipient and/or Established Nephropathy
This study will evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
- Conditions
- Diabetes Type 2
- Being tested
- Aliskiren
- Keywords
- Time course, antiproteinuric, blood pressure, lowering effect, initiation of renin inhibition, Aliskiren in Type 2 diabetes, incipient and/or established 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
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
Secondary outcomes (2)
To measure blood pressure changes over time during the onset and offset of effect.
To investigate whether there is a change on biomarkers of inflammation and cardiovascular risk.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startAug 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461136
- Sponsor's protocol ID
- CSPP100A2242
- Status last verified
- Sep 2016
- First submitted
- 16 Apr 2007
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-period, One-treatment Study to Evaluate the Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes Suffering From Incipient and/or Established Nephropathy
- ClinicalTrials.gov ID
- NCT00461136
- Acronym / sponsor ID
- CSPP100A2242
- Conditions
- Diabetes Type 2
- Keywords
- Time course, antiproteinuric, blood pressure, lowering effect, initiation of renin inhibition, Aliskiren in Type 2 diabetes, incipient and/or established nephropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 17 Apr 2007 (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.
This study will evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and/or female patients from 30-80 years of age with a diagnosis of Type 2 diabetes (WHO criteria).
- Incipient and established diabetic nephropathy (urinary albumin excretion ≥ 100 mg/day but ≤ 2000 mg/day).
- Glomerular filtration rate (GFR) ≥ 40 ml/min (estimated using Modification of Diet in Renal Disease (MDRD) formula) in the last 4 months.
- 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.
- To be eligible 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 baseline (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to baseline (Day -1).; Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1).
Key exclusion criteria (35 listed)
- 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 drug (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 MDRD formula
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 |
|---|---|---|
| Aliskiren | Drug | – |
Primary outcome
To evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
2 secondary outcomes
To measure blood pressure changes over time during the onset and offset of effect.
To investigate whether there is a change on biomarkers of inflammation and cardiovascular risk.
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 23 Sep 2016.
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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.
Novartis principal investigator
Investigative site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aliskiren in people with Diabetes 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 10 inclusion and 35 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 23 Sep 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 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?
To evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.. It is what the study was designed to measure, not a finding.
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 23 Sep 2016.