Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00770081
Collaborator
(none)
75
87
2
30.9
0.9
0
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)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
75 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 Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and 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
|
| Active Comparator: 2 sitagliptin (25mg qd) |
Drug: sitagliptin
25mg qd
|
Outcome Measures
Primary Outcome Measures
- Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest) [52 weeks]
Secondary Outcome Measures
- To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment [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 and consent for extension
Exclusion Criteria:
- Patient unable to comply with core study requirements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama Medical Center | Mobile | Alabama | United States | 36617 |
| 2 | Anasazi Internal Medicine | Phoenix | Arizona | United States | 85032 |
| 3 | Sonoran Health Specialists | Scottsdale | Arizona | United States | 85260 |
| 4 | Mary K. Richards, MD. PA | Little Rock | Arkansas | United States | 72204 |
| 5 | University of Arkanasas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 6 | Burlingame | California | United States | 94010 | |
| 7 | John Muir Clinical Research | Concord | California | United States | 94520 |
| 8 | Academic Medical Research Institute | Los Angeles | California | United States | 90022 |
| 9 | UCLA Medical Center | Los Angeles | California | United States | 90095 |
| 10 | Northern California Institute for Bone Health | Oakland | California | United States | |
| 11 | Dr. Wei Feng | Pasadena | California | United States | 91101 |
| 12 | Sierra Clinical Research - Orangevale | Roseville | California | United States | 95661 |
| 13 | California Institute of Renal Research | San Diego | California | United States | 92123 |
| 14 | Denver Nephrology PC | Denver | Colorado | United States | 80230 |
| 15 | Western Nephrology & Metabolic Bone Disease PC | Lakewood | Colorado | United States | 80214 |
| 16 | Western Nephrology & Metabolic Bone Disease PC | Westminster | Colorado | United States | 80031 |
| 17 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 18 | Nephrology Associates of South Miami | Aventura | Florida | United States | 33180 |
| 19 | University of Florida Shands Hospital | Gainesville | Florida | United States | 32610 |
| 20 | Center for Diabetes & Endocrine Care | Hollywood | Florida | United States | 33021 |
| 21 | Larry Levinson, D.O., PA | Hollywood | Florida | United States | 33021 |
| 22 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 23 | Osler Medical Clinical Research | Melbourne | Florida | United States | 32901 |
| 24 | Tampa Bay Nephrology Associates | Tampa | Florida | United States | 33603 |
| 25 | Atlanta Diabetes Associates | Atlanta | Georgia | United States | 30309 |
| 26 | Emory Clinic | Atlanta | Georgia | United States | 30322 |
| 27 | University of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 28 | Boise Kidney & Hypertension Institiute | Meridian | Idaho | United States | 83642 |
| 29 | Iowa Diabetes & Endocrinology Research Center PLC | Des Moines | Iowa | United States | 50314 |
| 30 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 31 | Cray Diabetes Education Center | Kansas City | Kansas | United States | 66160 |
| 32 | Cotton-O'Neil Diabetes & Endocrinology Center | Topeka | Kansas | United States | 66606 |
| 33 | Metabolic Center of Louisiana | Baton Rouge | Louisiana | United States | 70808 |
| 34 | Dolby Research, LLC | Baton Rouge | Louisiana | United States | 70809 |
| 35 | Bruce Samuels LLC | Covington | Louisiana | United States | 70433 |
| 36 | Egan Healthcare | Metairie | Louisiana | United States | 70002 |
| 37 | Crescent City Clinical Research Center | Metairie | Louisiana | United States | 70006 |
| 38 | Arthritis and Diabetes Clinic | Monroe | Louisiana | United States | 71203 |
| 39 | Northwest Louisiana Nephrology Research | Shreveport | Louisiana | United States | 71101-4440 |
| 40 | Joslin Diabetes Center at North Arundel Hospital | Glen Burnie | Maryland | United States | 21061 |
| 41 | Biolab Research, LLC | Rockville | Maryland | United States | 20852-1542 |
| 42 | Harvard University (Joslin Diabetes Center) | Boston | Massachusetts | United States | 02215 |
| 43 | Genesys Integrated Group Practice, PC | Flint | Michigan | United States | 49532 |
| 44 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
| 45 | Phillips Medical Services, PLLC | Jackson | Mississippi | United States | 39209 |
| 46 | Mississippi Medical Research, LLC | Picayune | Mississippi | United States | 39466 |
| 47 | Diabetes and Endocrinology Specialist, Inc | Chesterfield | Missouri | United States | 63017 |
| 48 | Jefferson City Medical Group | Jefferson City | Missouri | United States | 65109 |
| 49 | Arms, Dodge, Robinson, Wilber & Crouch, Inc. | Kansas City | Missouri | United States | 64111 |
| 50 | Washington U School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 51 | Platte Valley Medical Group | Kearney | Nebraska | United States | 68848 |
| 52 | Creighton Diabetes Center | Omaha | Nebraska | United States | 68131 |
| 53 | Creighton Nephrology | Omaha | Nebraska | United States | 68131 |
| 54 | UMDNJ-Robert Wood Johnson | New Brunswick | New Jersey | United States | 08903 |
| 55 | University of New Mexico Health Science Center | Albuquerque | New Mexico | United States | 87131 |
| 56 | Downstate University of Brooklyn | Brooklyn | New York | United States | 11203-2056 |
| 57 | HRRG | Orchard Park | New York | United States | 14127 |
| 58 | SUNY - Upstate Medical University | Syracuse | New York | United States | 13210 |
| 59 | Meritcare Medical Group | Fargo | North Dakota | United States | 58122 |
| 60 | University of Cincinnati | Cincinnati | Ohio | United States | 45206 |
| 61 | Hightop Medical Research Center | Cincinnati | Ohio | United States | 45224 |
| 62 | The Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 63 | Willamette Valley Clinical Studies | Eugene | Oregon | United States | 97404 |
| 64 | Portland Hypertension and Nephrology | Oregon City | Oregon | United States | 97045 |
| 65 | Lehigh Valley Hospital-Dept. of Medicine Research | Allentown | Pennsylvania | United States | 18105 |
| 66 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 67 | Renal Endocrine Associates, P. C. | Pittsburgh | Pennsylvania | United States | 15224 |
| 68 | Aiken Center for Clinical Research | Aiken | South Carolina | United States | 29801 |
| 69 | Medical U of South Carolina | Charleston | South Carolina | United States | 29425 |
| 70 | SC Nephrology and Hyptertension Center, Inc. | Orangeburg | South Carolina | United States | 29115 |
| 71 | Sumter Medical Specialists | Sumter | South Carolina | United States | 29150 |
| 72 | AM Diabetes and Endocrinology Center | Bartlett | Tennessee | United States | 38133 |
| 73 | Medical Nephrology Associates | Dyersburg | Tennessee | United States | 38024 |
| 74 | Dallas Diabetes & Endocrine Center | Dallas | Texas | United States | 75230 |
| 75 | North Texas Endocrine Center | Dallas | Texas | United States | 75231 |
| 76 | Texas Tech University Health Sciences Center | El Paso | Texas | United States | 79905 |
| 77 | Baylor Clinic (BCM 621) | Houston | Texas | United States | 770303411 |
| 78 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 79 | Renal Associates, P.A. | San Antonio | Texas | United States | 78215 |
| 80 | Allied Institute of Medicine | San Antonio | Texas | United States | 78222 |
| 81 | Central Utah Clinic | American Fork | Utah | United States | 84003 |
| 82 | Clinical Research and Consulting Center, LLC | Fairfax | Virginia | United States | 22030 |
| 83 | Nephrology Associates of Northern Virginia | Fairfax | Virginia | United States | 22033 |
| 84 | Medical College of Virginia | Richmond | Virginia | United States | 23298-0111 |
| 85 | Medical College of Virginia | Richmond | Virginia | United States | 23298 |
| 86 | Washington State University at Spokane | Spokane | Washington | United States | 99202 |
| 87 | UW Health - West Clinic | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00770081
Other Study ID Numbers:
- CLAF237A23138E1
First Posted:
Oct 9, 2008
Last Update Posted:
Dec 17, 2020
Last Verified:
May 1, 2012
Keywords provided by Novartis
Additional relevant MeSH terms: