Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00818571
First received: January 6, 2009
Last updated: September 23, 2010
Last verified: September 2010
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Purpose
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Impairment Diabetes |
Drug: Vildagliptin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Measure: pharmacokinetics of vildagliptin and its metabolites [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measure: safety assessments will include vital signs, electrocardiograms and adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 96 |
| Study Start Date: | December 2008 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vildagliptin 25 mg qd in RI patients |
Drug: Vildagliptin
Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
|
| Experimental: Vildagliptin 50 mg qd in RI Patients |
Drug: Vildagliptin
Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
|
| Experimental: Vildagliptin 25 mg qd in matched HV |
Drug: Vildagliptin
Matching healthy volunteers receiving 25 mg vildagliptin once daily.
|
| Experimental: Vildagliptin 50 mg qd in matched HV |
Drug: Vildagliptin
Matching healthy volunteers receiving 50 mg vildagliptin once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to <50 ml/min) and severe (CrCl of <30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of >80 ml/min
Exclusion Criteria:
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00818571 History of Changes |
| Other Study ID Numbers: | CLAF237B2202, 2008-004565-25 |
| Study First Received: | January 6, 2009 |
| Last Updated: | September 23, 2010 |
| Health Authority: | Russia: Ministry of Health of the Russian Federation United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Renal impairment Diabetes vildagliptin Galvus Eucreas |
Additional relevant MeSH terms:
|
Diabetes Mellitus Renal Insufficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Kidney Diseases Urologic 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 May 16, 2013