Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00765830
Collaborator
(none)
349
90
2
30.9
3.9
0.1
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
349 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency
Study Start Date
:
Sep 1, 2008
Actual Primary Completion Date
:
Apr 1, 2011
Actual Study Completion Date
:
Apr 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 50mg qd vildagliptin |
Drug: vildagliptin
50mg qd
|
| Placebo Comparator: 2 Placebo |
Drug: Placebo
qd
|
Outcome Measures
Primary Outcome Measures
- To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment [52 weeks]
Secondary Outcome Measures
- To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency [52 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Complete the core study
Exclusion Criteria:
- Did not comply with core study requirements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinica de Fracturas y Ortopedia | Buenos Aires | Argentina | ||
| 2 | Hospital Teodoro Alvarez | Buenos Aires | Argentina | ||
| 3 | Instituto de Investigaciones Clinicas de Mar del Plata | Buenos Aires | Argentina | ||
| 4 | Instituto Medico Especializado IME | Buenos Aires | Argentina | ||
| 5 | Clinica Reina Fabiola | Cordoba | Argentina | ||
| 6 | Hospital Juan Ramon Vidal | Corrientes | Argentina | ||
| 7 | Hospital Zenon J. Santillan | San Miguel de Tucuman | Argentina | ||
| 8 | The Queen Elizabeth Hospital | Woodville | South Australia | Australia | |
| 9 | Heidelberg Repatriation Hospital | Heidelberg Heights | Australia | ||
| 10 | SA Endocrine Clinical Research | Keswick | Australia | ||
| 11 | Keogh Medical Research Institute | Nedlands Perth | Australia | ||
| 12 | St Vincent's Hospital (Melb) | Victoria | Australia | ||
| 13 | ERS Endocrine Research Society | Vancouver | British Columbia | Canada | |
| 14 | Health Sciences Centre - Diabetes Research Group | Winnipeg | Manitoba | Canada | |
| 15 | Co Medica Research Network Inc. | Courtice | Ontario | Canada | |
| 16 | Ultra Med Inc. | Pointe-Claire | Quebec | Canada | |
| 17 | Centre de Recherche de Laval | Laval | Canada | ||
| 18 | Private Office (Gottesman) | Ontario | Canada | ||
| 19 | Hopital Maisonneuve-Rosemont | Quebec | Canada | ||
| 20 | Health Sciences Centre - Diabetes Research Group | Winnipeg | Canada | ||
| 21 | Clínica Vía San Juan | Cartago | Costa Rica | ||
| 22 | Clínica de Endocrinología y Diabetes | San Jose | Costa Rica | ||
| 23 | Clínica San Agustín | San Jose | Costa Rica | ||
| 24 | Hospital Clínica Bíblica | San Jose | Costa Rica | ||
| 25 | Satakunnan Keskussairaala | Pori | Finland | ||
| 26 | Mediwest Research Center | Seinajoki | Finland | ||
| 27 | Tampereen lääkärikeskus Oy, Koskiklinikka | Tampere | Finland | ||
| 28 | Cabinet du Dr Arnou | Angers | France | ||
| 29 | Cabinet du Dr Giraud Philippe | Angers | France | ||
| 30 | Hôpital Docteur Duchenne | Boulogne-sur-Mer | France | ||
| 31 | Hopital Albert Michallon | Grenoble cedex 9 | France | ||
| 32 | Cabinet médical | Laval | France | ||
| 33 | Hopital Dupuytren | Limoges Cedex | France | ||
| 34 | Hopital Edouard Herriot | Lyon | France | ||
| 35 | Zentralklinikum Augsburg | Augsburg | Germany | ||
| 36 | Praxis Dr. Maxeiner | Bad Kreuznach | Germany | ||
| 37 | Universitaetsklinik Charitè | Berlin | Germany | ||
| 38 | Praxis Dr. Fischer | Darmstadt | Germany | ||
| 39 | Praxis Dr. Merker | Dormagen | Germany | ||
| 40 | Univ.-Klinikum Erlangen | Erlangen | Germany | ||
| 41 | Kardiol. Gemeinschaftspraxis PD Dr. Winkelmann | Frankfurt | Germany | ||
| 42 | Universitätsklinikum Frankfurt | Frankfurt | Germany | ||
| 43 | Medizinische Hochschule Hannover | Hannover | Germany | ||
| 44 | Friedrich Schiller Universitaet Jena | Jena | Germany | ||
| 45 | CRS Clinical Research Services Gmbh | Kiel | Germany | ||
| 46 | I. Medizinische Univ.-Klinik | Kiel | Germany | ||
| 47 | Praxis Dr. Hennig | Meissen | Germany | ||
| 48 | Praxis Dr. Grimm | Muenchen | Germany | ||
| 49 | Univ.-Klinikum München, Campus Innenstadt | München | Germany | ||
| 50 | Praxis Dr. Schoell | Nuernberg | Germany | ||
| 51 | Forschungszentrum Ruhr, KliFoCenter GmbH | Witten | Germany | ||
| 52 | Universitaetsklinik im Luitpold-Krankenhaus | Wuerzburg | Germany | ||
| 53 | Gujarat Endocrine Centre | Ahmedabad | India | ||
| 54 | M V Hospital for Diabetes and Diabetic Research Center | Chennai | India | ||
| 55 | Coimbatore Diabetes Foundation | Coimbatore | India | ||
| 56 | S.R. Kalla Memorial Gastro & General Hospital | Jaipur | India | ||
| 57 | Meenakshi Mission Hospital & Research Centre | Madurai | India | ||
| 58 | Diabetes Clinic & Research Centre | Nagpur | India | ||
| 59 | Storoklinikken | Oslo | Norway | ||
| 60 | St. Olavs Hospital, Endokrinologisk seksjon | Trondheim | Norway | ||
| 61 | City Clinical Hospital #6 | Chelyabinsk | Russian Federation | ||
| 62 | City Clinical Hospital #1 | Moscow | Russian Federation | ||
| 63 | City Clinical Hospital No.11 | Moscow | Russian Federation | ||
| 64 | MSU of Medicine and Dentistry on the base of CityHospital 23 | Moscow | Russian Federation | ||
| 65 | MSUMD on the base of City Clinical Hospital #67 | Moscow | Russian Federation | ||
| 66 | City polyclinic # 17, City Diabetic Centre #3 | Saint Petersburg | Russian Federation | ||
| 67 | Krestovsky Island Medical Institute | Saint Petersburg | Russian Federation | ||
| 68 | Saint- Petersburg State Mtchnikov's Medical Academy | Saint-Petersburg | Russian Federation | ||
| 69 | Saint-Petersburg State Pavlov's Medical University | Saint-Petersburg | Russian Federation | ||
| 70 | Site Management Organisation of Clinical Trials Centers | Smolensk | Russian Federation | ||
| 71 | Tyumen State Medicine Academy | Tyumen | Russian Federation | ||
| 72 | Clinica Mediterranea de Neurociencias | Alicante | Spain | ||
| 73 | Hospital de la Ribera | Alzira | Spain | ||
| 74 | Hospital Clinic I Provincial de Barcelona | Barcelona | Spain | ||
| 75 | Centro de Salud Begonte | Begonte | Spain | ||
| 76 | Hospital San Pedro de Alcantara | Caceres | Spain | ||
| 77 | Hospital Universitario Reina Sofia | Cordoba | Spain | ||
| 78 | Ciutat Sanitaria I Universitaria de Bellvitge | Hospitalet de Llobregat | Spain | ||
| 79 | Hospital General de Jerez de La Frontera | Jerez de La Frontera | Spain | ||
| 80 | Complejo Universitario de San Carlos | Madrid | Spain | ||
| 81 | Hospital de Merida | Merida | Spain | ||
| 82 | Hospital Son Dureta | Palma De Mallorca | Spain | ||
| 83 | Consorci Hospitalari Parc Tauli | Sabadell | Spain | ||
| 84 | Hospital Clinico Universitario Santiago de Compostela | Santiago de Compostela | Spain | ||
| 85 | Eap El Remei - Vic | Vic | Spain | ||
| 86 | ME3PLUS Clinical Trials | Goteborg | Sweden | ||
| 87 | Njurmedicin, Sahlgrenska Univ.sjukhuset | Goteborg | Sweden | ||
| 88 | Metabolmottagningen, Lasarettet, Kristianstad | Kristianstad | Sweden | ||
| 89 | VO Endokrinologi/Diabetologi Universitetssjukhuset | Lund | Sweden | ||
| 90 | Ladulaas Kliniska Studier | Skene | Sweden |
Sponsors and Collaborators
- Novartis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00765830
Other Study ID Numbers:
- CLAF237A23137E1
First Posted:
Oct 3, 2008
Last Update Posted:
Dec 17, 2020
Last Verified:
Jan 1, 2013
Keywords provided by Novartis
Additional relevant MeSH terms: