Diabetes Mellitus, Type 2Phase 4NCT00238472
A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion
A Phase 4 study testing nateglinide in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals.
Trial summary
This study is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- nateglinide
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jun 2005
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Type 2 diabetes diagnosed at least 1 year before inclusion
- Blood glucose criteria must be met
- Microalbuminuria criteria must be met
Who cannot join
- Pregnant or nursing females or females of childbearing potential not using a medically approved birth control method
- Blood glucose criteria outside the specified range
- Microalbuminuria criteria outside the specified range
- Serious cardiovascular events within the past 6 months
- Other protocol-defined exclusion criteria may apply
About this study
This study is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- nateglinide
- Keywords
- Type 2 diabetes, nateglinide
- 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.
nateglinideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postprandial glomerular filtration rate at 12 weeks
Secondary outcomes (5)
Change from baseline in fasting morning glomerular filtration rate at 12 weeks
Change from baseline in postprandial renal plasma flow at 12 weeks
Change from baseline in fasting morning renal plasma flow at 12 weeks
Change from baseline in adjusted 2-hour postprandial glucose at 12 weeks
Change in insulin AUC (0-240 minutes) at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startMay 2003
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238472
- Sponsor's protocol ID
- CDJN608AIT05
- Status last verified
- Apr 2012
- First submitted
- 12 Oct 2005
- Last updated
- 27 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion
- ClinicalTrials.gov ID
- NCT00238472
- Acronym / sponsor ID
- CDJN608AIT05
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, nateglinide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 13 Oct 2005 (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 is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes diagnosed at least 1 year before inclusion
- Blood glucose criteria must be met
- Microalbuminuria criteria must be met
Key exclusion criteria (5 listed)
- Pregnant or nursing females or females of childbearing potential not using a medically approved birth control method
- Blood glucose criteria outside the specified range
- Microalbuminuria criteria outside the specified range
- Serious cardiovascular events within the past 6 months
- Other protocol-defined exclusion criteria may apply
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 |
|---|---|---|
| nateglinide | Drug | – |
Primary outcome
Change from baseline in postprandial glomerular filtration rate at 12 weeks
5 secondary outcomes
Change from baseline in fasting morning glomerular filtration rate at 12 weeks
Change from baseline in postprandial renal plasma flow at 12 weeks
Change from baseline in fasting morning renal plasma flow at 12 weeks
Change from baseline in adjusted 2-hour postprandial glucose at 12 weeks
Change in insulin AUC (0-240 minutes) at 12 weeks
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 27 Apr 2012.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nateglinide in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals.
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 3 inclusion and 5 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline in postprandial glomerular filtration rate at 12 weeks. 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 27 Apr 2012.