Type 2 Diabetes MellitusPhase 1NCT00572650
Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients
A Phase 1 study testing vildagliptin in people with Type 2 Diabetes Mellitus, run by Novartis at 1 site in Germany.
Trial summary
This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Nov 2007
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years of age (inclusive).
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method.
- Body mass index (BMI) ≤42 kg/m2 (inclusive) at Screening.
- 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.
- For renal insufficient patients only
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- Patients must have stable renal disease without evidence of renal progressive disease
- If patient is diabetic, must be treated with standard anti-diabetic therapy andmust agree to continue their anti-diabetic therapy throughout the duration of the study.
- If patient is diabetic, must be on a stable dose of standard anti-diabetic therapy or diet and exercise regimen over the past 4 weeks prior to Screening.
- For healthy subjects only
- No current significant medical conditions as determined by history and physical.
- A serum creatinine with a calculated CrCl of >80 ml/min.
- Matched to renal impaired patients (Group A) undergoing study by age (±5 years), sex and weight (±10% BMI).
Who cannot join
- Subjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:
- Pregnant or lactating female.
- A history of certain disorders as specified in the protocol.
- Subjects that have been enrolled in a LAF237 (vildagliptin) study or other DPP-4 inhibitor studies six months prior to Baseline.
- History of renal transplant at any time in the past and on immunosuppressant therapy.
- Acute infections which may affect blood glucose control within 4 weeks prior to Screening and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
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- Certain electrocardiogram (ECG) abnormalities:
- Malignancy including leukemia and lymphoma (not including basal cell skin cancer) 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 (hemodialysis or peritoneal dialysis)
- Concurrent medical condition that may interfere with the interpretation of safety and tolerability data during the study.
- Use of certain medications as specified in the protocol.
- Laboratory abnormalities as defined by the protocol
- History of active substance abuse (including alcohol) within the past 2 years.
- Smokers defined as any subject who reports heavy cigarette use (i.e., 10 or more cigarettes per day). Urine cotinine will also be measured and recorded at Screening and Baseline.
- 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, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of LAF237 and Its Metabolites in Mild Renal Impaired Patients Compared to Age, Sex and Weight-matched Healthy Volunteers Following Daily Doses of 100 mg LAF237 for 14 Days
This study will evaluate the pharmacokinetics of vildagliptin (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- vildagliptin
- Keywords
- Type-2 diabetes, DPP-4 inhibitor, vildagliptin
- 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.
vildagliptinDrug
16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described 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 posted13 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- NOVARTIS, Principal investigator, Novartis investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572650
- Sponsor's protocol ID
- CLAF237A2117
- Status last verified
- Apr 2012
- First submitted
- 12 Dec 2007
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. 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 LAF237 and Its Metabolites in Mild Renal Impaired Patients Compared to Age, Sex and Weight-matched Healthy Volunteers Following Daily Doses of 100 mg LAF237 for 14 Days
- ClinicalTrials.gov ID
- NCT00572650
- Acronym / sponsor ID
- CLAF237A2117
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type-2 diabetes, DPP-4 inhibitor, vildagliptin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 13 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 (LAF237) and its metabolites in patients with mild renal impairment compared to their sex, age and weigh based healthy volunteer counterparts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: vildagliptin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age from 18 to 75 years of age (inclusive).
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method.
- Body mass index (BMI) ≤42 kg/m2 (inclusive) at Screening.
- 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.
Key exclusion criteria (17 listed)
- Subjects meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:
- Pregnant or lactating female.
- A history of certain disorders as specified in the protocol.
- Subjects that have been enrolled in a LAF237 (vildagliptin) study or other DPP-4 inhibitor studies six months prior to Baseline.
- History of renal transplant at any time in the past and on 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 |
|---|---|---|
| vildagliptin16 volunteers in each group of mild renal impairment patients and their matched healthy volunteers will receive once daily doses of 100mg LAF237 for 14 days. | 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 2 May 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 principal investigator
Novartis investigator 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 study testing vildagliptin in people with Type 2 Diabetes Mellitus, run by Novartis at 1 site in Germany.
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 17 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 2 May 2012. 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 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 2 May 2012.