Pharmacokinetic Study of LAF237 and Its Metabolites in Mild Renal Impaired Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572650
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : May 2, 2012
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: vildagliptin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: vildagliptin
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.

Primary Outcome Measures :
  1. Pharmacokinetic measures [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. Safety and tolerability measures [ Time Frame: throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

  • 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).

Exclusion Criteria:

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572650

Novartis Investigator Site
Kiel, Germany
Sponsors and Collaborators
Principal Investigator: NOVARTIS Novartis investigator site

Responsible Party: Novartis Identifier: NCT00572650     History of Changes
Other Study ID Numbers: CLAF237A2117
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012

Keywords provided by Novartis:
Type-2 diabetes, DPP-4 inhibitor, vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs