Type-2 DiabetesPhase 1NCT00567047
Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment
A Phase 1 study testing vildagliptin in people with Type-2 Diabetes, run by Novartis at 6 sites in 2 countries.
Trial summary
This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Type-2 Diabetes
- What is being tested?
- vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2007to Jan 2009
- Phase
- Phase 1
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women (age 18 to 85 years)
- Participants must be nonfertile or using a medically approved birth control method. Additional information regarding this requirement available at screening
- Body mass index (BMI) ≤42 kg/m2 (inclusive)
- Patients with mild, moderate, or severe kidney impairment. Please consult with participating physicians regarding the definitions of these levels of severity.
- Patients with diabetes must be treated with standard anti-diabetic therapy (diet and exercise, stable dose of sulfonylurea, insulin, or metiglinides) and agree to continue for the study duration
- No current significant medical conditions as determined by history and physical.
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- Serum creatinine with a calculated creatinine clearance (CrCl) of >80 ml/min.
- Matched to renal impaired patients in the study by age (±5 years), sex and weight (±10% BMI)
- Vital signs guided by the following ranges:
- oral body temperature between 35.0-37.2 °C systolic blood pressure, 100-140 mm Hg diastolic blood pressure, 60-110 mm Hg pulse rate, 45-90 bpm
Who cannot join
- Pregnant or lactating female.
- A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications (eg, ketoacidosis or hyperosmolar state (coma))
- Subjects that have been enrolled in previous vildagliptin studies or other DPP
- 4 inhibitor studies within six months
- History of renal transplant or immunosuppressant therapy
- Acute infections which may affect blood glucose control or other medical condition that may interfere with the interpretation of efficacy and safety data during the study
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- Any pre-existing or history of diabetic ulcer
- Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke
- Any of the following electrocardiogram (ECG) abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree atrioventricular (AV) block (Mobitz 1 and 2), third degree AV block, prolonged QTc (>500 ms)
- Malignancy including leukemia and lymphoma within the last 5 years.
- Liver disease such as cirrhosis or positive hepatitis B and C.
- Any alcohol related hepatic disease.
- Patients undergoing any method of dialysis
- Use of some concomitant medications
- Significant laboratory abnormalities as specified in the protocol
- History of active substance abuse (including alcohol) within the past 2 years.
- Smokers (i.e., 10 or more cigarettes per day)
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Novartis Investigator Site
Knoxville, Tennessee, 37920
Novartis Investigator Site
Miami, Florida, 33136
Novartis Investigator Site
Minneapolis, Minnesota, 55404
Novartis Investigator Site
Orlando, Florida, 32809
Novartis Investigator Site
Richmond, Virginia, 23298
About this study
Official title: An Open-Label, Parallel-Group Study to Determine the Single and Multiple Dose Pharmacokinetics of Vildagliptin and Its Metabolites in Mild, Moderate or Severe Renal Impaired Patients Compared to Age, Sex and Weight-Matched Healthy Volunteers Following Daily Doses of 50 mg Vildagliptin for 14 Days
This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.
- Conditions
- Type-2 Diabetes
- Being tested
- vildagliptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vildagliptinDrug
Also called LAF237
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Vildagliptin Receives: Drug: vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Pharmacokinetic measures
Measured: throughout the study
Secondary outcomes (1)
• Safety and tolerability measures
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-2 DiabetesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Novartis investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567047
- Sponsor's protocol ID
- CLAF237A2115
- Status last verified
- Mar 2009
- First submitted
- 3 Dec 2007
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel-Group Study to Determine the Single and Multiple Dose Pharmacokinetics of Vildagliptin and Its Metabolites in Mild, Moderate or Severe Renal Impaired Patients Compared to Age, Sex and Weight-Matched Healthy Volunteers Following Daily Doses of 50 mg Vildagliptin for 14 Days
- ClinicalTrials.gov ID
- NCT00567047
- Acronym / sponsor ID
- CLAF237A2115
- Conditions
- Type-2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- First posted
- 4 Dec 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 pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: vildagliptinVildagliptin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women (age 18 to 85 years)
- Participants must be nonfertile or using a medically approved birth control method. Additional information regarding this requirement available at screening
- Body mass index (BMI) ≤42 kg/m2 (inclusive)
- Patients with mild, moderate, or severe kidney impairment. Please consult with participating physicians regarding the definitions of these levels of severity.
- Patients with diabetes must be treated with standard anti-diabetic therapy (diet and exercise, stable dose of sulfonylurea, insulin, or metiglinides) and agree to continue for the study duration
Key exclusion criteria (19 listed)
- Pregnant or lactating female.
- A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications (eg, ketoacidosis or hyperosmolar state (coma))
- Subjects that have been enrolled in previous vildagliptin studies or other DPP
- 4 inhibitor studies within six months
- History of renal transplant or immunosuppressant therapy
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 |
|---|---|---|
| vildagliptinAlso: LAF237 | Drug | 1 |
Primary outcome
• Pharmacokinetic measures
Time frame: throughout the study
1 secondary outcome
• Safety and tolerability measures
Time frame: throughout the study
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 25 Mar 2009.
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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
Novartis investigative site
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vildagliptin in people with Type-2 Diabetes, run by Novartis at 6 sites in 2 countries.
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 19 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 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany. 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 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.
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?
• Pharmacokinetic measures (time frame: throughout the study). 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 25 Mar 2009.