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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00572650
First received: December 12, 2007
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: vildagliptin
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pharmacokinetic measures [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability measures [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: October 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572650

Locations
Germany
Novartis Investigator Site
Kiel, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: NOVARTIS Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00572650     History of Changes
Other Study ID Numbers: CLAF237A2117
Study First Received: December 12, 2007
Last Updated: April 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014