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

NCT00572650 | Completed Phase 1

• 1 other identifier: CLAF237A2117
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type-2 diabetes, DPP-4 inhibitor, vildagliptin

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic measures

  throughout the study

Secondary Outcomes (1)

• Safety and tolerability measures

  throughout the study

Study Arms (1)

1

ACTIVE COMPARATOR

Drug: vildagliptin

Interventions

vildagliptin DRUG

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.

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigator Site

Kiel, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• NOVARTIS

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 2, 2012

Record last verified: 2012-04

Locations

DE (1)