Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00646542
First received: March 24, 2008
Last updated: January 3, 2013
Last verified: January 2013
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Purpose
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Vildagliptin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 525 |
| Study Start Date: | March 2005 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Vildagliptin
Other Name: Galvus
|
| Placebo Comparator: 2 | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History T2DM
- Moderate or Severe Renal Impairment
Exclusion Criteria:
- Glucose > 270 mg/dL (>15 mmol/L)
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646542
Locations
| Argentina | |
| Buenos Aires, Argentina | |
| Australia | |
| Heidelberg Heights, Australia | |
| Canada | |
| Winnipeg, Canada | |
| Costa Rica | |
| Cartago, Costa Rica | |
| Finland | |
| Tampere, Finland | |
| France | |
| Angers, France | |
| Germany | |
| Dormagen, Germany | |
| India | |
| Chennai, India | |
| Norway | |
| Oslo, Norway | |
| Russian Federation | |
| Saint Petersburg, Russian Federation | |
| Spain | |
| Alicante, Spain | |
| Sweden | |
| Lund, Sweden | |
Sponsors and Collaborators
Novartis
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00646542 History of Changes |
| Other Study ID Numbers: | CLAF237A23137 |
| Study First Received: | March 24, 2008 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Costa Rica: Ministry of Health Costa Rica Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices India: Drugs Controller General of India Norway: Norwegian Medicines Agency Russia: Ministry of Health of the Russian Federation Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Type 2 diabetes, vildagliptin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 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