Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00821977
Collaborator
(none)
338
176
3
23
1.9
0.1
Study Details
Study Description
Brief Summary
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
338 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date
:
Nov 1, 2008
Actual Primary Completion Date
:
Oct 1, 2010
Actual Study Completion Date
:
Oct 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vildagliptin Dose 1
|
Drug: Vildagliptin
|
| Experimental: Vildagliptin Dose 2
|
Drug: Vildagliptin
|
| Placebo Comparator: Placebo
|
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks. [24 weeks]
Secondary Outcome Measures
- Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks [24 weeks]
- Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM [24 weeks]
- Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM [76 weeks]
- Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM [24 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients at least 18 years of age at Visit 1
-
Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
-
HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
-
Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1
Exclusion Criteria:
-
Pregnant or lactating female
-
FPG ≥ 270 mg/dL (≥15 mmol/L)
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advanced Clinical Research | Pell City | Alabama | United States | 35128 |
| 2 | Horizon Clinical Research Associates, PLLC | Gilbert | Arizona | United States | 85206 |
| 3 | Vista Medical Research, Inc | Mesa | Arizona | United States | 85206 |
| 4 | Clinical Research Advantage | Mesa | Arizona | United States | 85213 |
| 5 | Hope Clinical Research | Phoenix | Arizona | United States | 85006 |
| 6 | Anasazi Internal Medicine | Phoenix | Arizona | United States | 85032 |
| 7 | Tatum Ridge Internal Medicine | Phoenix | Arizona | United States | 85032 |
| 8 | Paradigm Clinical | Tucson | Arizona | United States | 85705 |
| 9 | Tucson Clinical Research | Tucson | Arizona | United States | 85712 |
| 10 | Medical Investigations, Inc. | Little Rock | Arkansas | United States | 72205 |
| 11 | Paul W. Davis, MD | Pine Bluff | Arkansas | United States | 71603 |
| 12 | Sall Research Medical Center | Artesia | California | United States | 90704 |
| 13 | Associated Pharmaceutical Research | Buena Park | California | United States | 90620 |
| 14 | Providence Research | Burbank | California | United States | 91505 |
| 15 | Burbank - Lovelace Scientific Resources, Inc. | Burbank | California | United States | 91506 |
| 16 | Lucita M. Cruz, M.D., Inc. | Norwalk | California | United States | 90650 |
| 17 | California Research Foundation | San Diego | California | United States | 92103 |
| 18 | Ritchken and First MDs | San Diego | California | United States | 92117-4961 |
| 19 | San Diego Sports Medicine Research and Family Care | San Diego | California | United States | 92120 |
| 20 | Crest Clinical Trials | Santa Ana | California | United States | 92701 |
| 21 | NuLife Clinical Research, Inc. | Santa Ana | California | United States | 92805 |
| 22 | Westside Arthritis and Metabolism Center | Santa Monica | California | United States | 90404 |
| 23 | Center for Clinical Trials of San Gabriel | West Covina | California | United States | 91790 |
| 24 | Colorado Springs Health Partners, Pc | Colorado Springs | Colorado | United States | 80907 |
| 25 | Express Care Clinical Research | Colorado Springs | Colorado | United States | 80909 |
| 26 | Cherry Creek Family Practice | Denver | Colorado | United States | 80206 |
| 27 | Metro Clinical Research | Littleton | Colorado | United States | 80120 |
| 28 | Complete Family Care | Northglenn | Colorado | United States | 80234 |
| 29 | Clinical Therapeutics Corp | Coral Gables | Florida | United States | 33134 |
| 30 | Fort Lauderdale | Florida | United States | 33308 | |
| 31 | South Florida Clinical Research Center | Miramar | Florida | United States | 33023 |
| 32 | Pines Research, LLC | Pembroke Pines | Florida | United States | 33028 |
| 33 | Well Pharma Medical Research | South Miami | Florida | United States | 33143 |
| 34 | Southern Clinical Research | Augusta | Georgia | United States | 30904 |
| 35 | Rockdale Medical Research | Conyers | Georgia | United States | 30094 |
| 36 | North Georgia Medical Research Institute | Ellijay | Georgia | United States | 30540 |
| 37 | Perimeter North Medical Research | Roswell | Georgia | United States | 30076 |
| 38 | JMG CIinical Research | Alton | Illinois | United States | 62002 |
| 39 | Fox Valley Clinical Research | Aurora | Illinois | United States | 60504 |
| 40 | American Health Network | Indianapolis | Indiana | United States | 46254 |
| 41 | Mercy Family Medicine | Mason City | Iowa | United States | 50401 |
| 42 | Associates Research, Inc | Lansing | Kansas | United States | 66043 |
| 43 | Health Science Research Center | Pratt | Kansas | United States | 67124 |
| 44 | Cotton O'neil Clinic | Topeka | Kansas | United States | 66606 |
| 45 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67205 |
| 46 | Dolby Research, LLC | Baton Rouge | Louisiana | United States | 70809 |
| 47 | Bruce Samuels LLC | Covington | Louisiana | United States | 70433 |
| 48 | Gulf Coast Research, LLC | Lafayette | Louisiana | United States | 70508 |
| 49 | Crescent City Clinical Research Center | Metairie | Louisiana | United States | 70006 |
| 50 | The Family Doctors | Shreveport | Louisiana | United States | 71115 |
| 51 | Maine Centers for Endocrinology & Diabetes | Scarborough | Maine | United States | 04074 |
| 52 | Michigan Hypertension Center | Chelsea | Michigan | United States | 48118 |
| 53 | Genesys Integrated Group Practice, PC | Flint | Michigan | United States | 48532 |
| 54 | Borgess Heart Institute-Borgess Research Institute | Kalamazoo | Michigan | United States | 49048 |
| 55 | NISUS Research Northern MI Hospital | Petoskey | Michigan | United States | 49770-2212 |
| 56 | Spence Medical Research Center, LLC | Pinckney | Michigan | United States | 39466 |
| 57 | Southwestern Medical Clinic, PC | Stevensville | Michigan | United States | 49127 |
| 58 | Belzoni Clinical Research | Belzoni | Mississippi | United States | 39038 |
| 59 | Gulfside Clinical Research | Gulfport | Mississippi | United States | 39501 |
| 60 | Mississippi Medical Research, LLC | Picayune | Mississippi | United States | 39466 |
| 61 | Woodlake Research | Chesterfield | Missouri | United States | 63017 |
| 62 | Truman Medical Center & Univ Physician Associates | Kansas City | Missouri | United States | 64108 |
| 63 | Ozark Mountains Medical Research | Ozark | Missouri | United States | 65721 |
| 64 | Midwest Pharmaceutical Research Inc. | Saint Peters | Missouri | United States | 63376 |
| 65 | Midwest Pharmaceutical Research, Inc. | Saint Peters | Missouri | United States | 63376 |
| 66 | Ozark Medical-Surgical Associates, Ltd. | Springfield | Missouri | United States | 65804 |
| 67 | ClinVest Research | Springfield | Missouri | United States | 65807 |
| 68 | Patient's First Health Care | Washington | Missouri | United States | 63090 |
| 69 | Physician Research Collaboration | Lincoln | Nebraska | United States | 68516 |
| 70 | Fallbrook Family Health Center | Lincoln | Nebraska | United States | 68521 |
| 71 | Quality Clinical Research | Omaha | Nebraska | United States | 68114 |
| 72 | Heartland Clinical Research, Inc. | Omaha | Nebraska | United States | 68134 |
| 73 | Desert Endocrinology Clinical Research Center | Henderson | Nevada | United States | 89052 |
| 74 | Clinical Research Center of NV | Las Vegas | Nevada | United States | 89104 |
| 75 | Palm Medical Research Center | Las Vegas | Nevada | United States | 89148 |
| 76 | Joslin Diabetes Center | Nashua | New Hampshire | United States | 03063 |
| 77 | Shore Health Group | Toms River | New Jersey | United States | 08753 |
| 78 | Physicians Research Center | Toms River | New Jersey | United States | 08755 |
| 79 | The Endocrine Group, LLP | Albany | New York | United States | 12206 |
| 80 | Endwell Family Physician | Endwell | New York | United States | 13760 |
| 81 | North Shore Diabetes and Endocrine Associates | New Hyde Park | New York | United States | 11042 |
| 82 | Mezitis Education & Research Institute | New York | New York | United States | 10024 |
| 83 | Cornerstone Medical Center | Burlington | North Carolina | United States | 27215 |
| 84 | Kernodle Clinic, Inc. | Burlington | North Carolina | United States | 27215 |
| 85 | Neem Research Group of Charlotte | Charlotte | North Carolina | United States | 28262 |
| 86 | Bland Clinic, PA | Greensboro | North Carolina | United States | 27401 |
| 87 | Triad Clinical Trials, LLC | Greensboro | North Carolina | United States | 27408 |
| 88 | Private Practice | Raleigh | North Carolina | United States | 27610 |
| 89 | Crescent Medical Research | Salisbury | North Carolina | United States | 28144 |
| 90 | Jones Family Practice, PA | Shelby | North Carolina | United States | 28150 |
| 91 | The Lipid Center | Statesville | North Carolina | United States | 28677 |
| 92 | Lillestol Research, LLC | Fargo | North Dakota | United States | 58103 |
| 93 | Frederick C. Smith Clinic R & R Research | Marion | Ohio | United States | 43302 |
| 94 | Pharmacotherapy Research Associates, INC | Zanesville | Ohio | United States | 43071 |
| 95 | Central Sooner Research | Norman | Oklahoma | United States | 73069 |
| 96 | Lion Research | Norman | Oklahoma | United States | 73069 |
| 97 | Integris Physicians Services Clinical Research | Oklahoma City | Oklahoma | United States | 73112 |
| 98 | Memorial Clinical Research | Oklahoma City | Oklahoma | United States | 73134 |
| 99 | Blair Medical Associates Inc | Altoona | Pennsylvania | United States | 16602 |
| 100 | Tri-State Medical Group | Beaver | Pennsylvania | United States | 15009 |
| 101 | Fleetwood Medical Associates | Fleetwood | Pennsylvania | United States | 19522 |
| 102 | Family Medical Associates | Levittown | Pennsylvania | United States | 19056 |
| 103 | New England Center for Clinical Research | Cranston | Rhode Island | United States | 02920 |
| 104 | Hartwell Research Group, LLC | Anderson | South Carolina | United States | 29621 |
| 105 | Low Country Internal Medicine | Charleston | South Carolina | United States | 29406 |
| 106 | Pharmacorp Clinical Trials, INC | Charleston | South Carolina | United States | 29412 |
| 107 | The Family Healthcare Center | Clinton | South Carolina | United States | 29325 |
| 108 | Columbia Clinical Research | Columbia | South Carolina | United States | 29201 |
| 109 | Med Plus South - Strand Family Practice | Garden City | South Carolina | United States | 29576 |
| 110 | DeGarmo Institute of Medical Research | Greer | South Carolina | United States | 29651 |
| 111 | Dorchester Medical Associates | Summerville | South Carolina | United States | 29485 |
| 112 | Southeastern Research Associates, Inc. | Taylors | South Carolina | United States | 28687 |
| 113 | Community Research Partners, Inc. | Varnville | South Carolina | United States | 29944 |
| 114 | AM Diabetes and Endocrinology Center | Bartlett | Tennessee | United States | 38133 |
| 115 | Tri-Cities Medical Research | Bristol | Tennessee | United States | 37620 |
| 116 | Holston Medical Group | Kingsport | Tennessee | United States | 37660 |
| 117 | ACRC Trials | Addison | Texas | United States | 75093 |
| 118 | Discover Research Inc. | Beaumont | Texas | United States | 77701 |
| 119 | MW Clinical Research | Beaumont | Texas | United States | 77701 |
| 120 | Discover Research | Bryan | Texas | United States | 77802 |
| 121 | Z&Z Medical Associates/Internal Medicine Clinical Research | Dallas | Texas | United States | 75235 |
| 122 | Western Sky Medical Research | El Paso | Texas | United States | 79902 |
| 123 | HCA Research | Houston | Texas | United States | 77025 |
| 124 | Texas Center for Drug Development, P.A. | Houston | Texas | United States | 77081 |
| 125 | Leading Edge Research, PA | Irving | Texas | United States | 75039 |
| 126 | R/D Clinical Research, Inc. | Lake Jackson | Texas | United States | 77566 |
| 127 | South Texas Institutes of Health | McAllen | Texas | United States | 78501 |
| 128 | Hill Country Medical Associates | New Braunfels | Texas | United States | 78130 |
| 129 | North Hills Family Practice | North Richland Hills | Texas | United States | 76180 |
| 130 | Naidu Clinic | Odessa | Texas | United States | 79761 |
| 131 | Med-Olam Clinical Research | Pasadena | Texas | United States | 77504 |
| 132 | Southwest Clinical Research Centers, LLC | Pearland | Texas | United States | 77584 |
| 133 | Diabetes & Glandular Disease Clinic , PA | San Antonio | Texas | United States | 78237 |
| 134 | Progressive Clinical Research | Bountiful | Utah | United States | 84010 |
| 135 | Utah Clinical Trials | Salt Lake City | Utah | United States | 84107 |
| 136 | Diabetes Research Center | South Burlington | Vermont | United States | 05403 |
| 137 | Northport VA Medical Center | Northport | Virginia | United States | 11768 |
| 138 | Holston Medical Group | Weber City | Virginia | United States | 24920 |
| 139 | Madrona Medical Group - Clinical Research Dept. | Bellingham | Washington | United States | 98226 |
| 140 | Summit Reserach Network, LLC | Seattle | Washington | United States | 98104 |
| 141 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431 |
| 142 | G.A. Research Associates Moncton, New Brunswick E1G 1 A7 | Moncton | New Brunswick | Canada | E1G 1 A7 |
| 143 | T.C. Health Center | Carbonear | Newfoundland and Labrador | Canada | A1Y 1C4 |
| 144 | LMC Endocrinology Centres (Barrie) Ltd. | Barrie | Ontario | Canada | L4M 7G1 |
| 145 | LMC Endocrinology Centres -(Etobicoke) Ltd. , | Etobicoke | Ontario | Canada | M9R 4E1 |
| 146 | LMC Endocrinology Centres -(Thornhill) | Thornhill | Ontario | Canada | L4J 8L7 |
| 147 | LMC Endocrinology Centres (Toronto) Ltd. | Toronto | Ontario | Canada | M4R 2G4 |
| 148 | Madras Diabetes Research Foundation | Gopalapuram | Chennai | India | 600 086 |
| 149 | Medicity Hospital | Hyderabaad | Hyderabad | India | 500 036 |
| 150 | Manipal Hospital | Bangalore | India | 560 017 | |
| 151 | MV Hospital for Diabetes and Diabetes Research Centre | Chennai | India | 600 013 | |
| 152 | Diabetes Thyroid Hormone Research Institute Pvt Ltd. | Indore | India | 452 001 | |
| 153 | Christian Medical College | Vellore | India | 632 004 | |
| 154 | University Malaya Medical Centre | Selangor Darul Ehsan | Ehsan | Malaysia | |
| 155 | Hospital University Kebangsaan Malaysia | Kuala Lumpur | Selangor Darul Ehsan | Malaysia | |
| 156 | Hospital Putrajaya | Selangor Darul Ehsan | Malaysia | ||
| 157 | Jose R. Reyes Memorial Medical Center | Sta Cruz | Manila | Philippines | |
| 158 | Metropolitan Medical Center | Manila | Philippines | ||
| 159 | Institute for Studies on Diabetes Foundation | Marikina City | Philippines | ||
| 160 | Policlinica Dr. Luis Rodriguez Carrasquillo | Carolina | Puerto Rico | 00983 | |
| 161 | Yolanda Sierra Medical Office | Levittown | Puerto Rico | 00949 | |
| 162 | Endocrine Lipid Diabetes Research Institute | Ponce | Puerto Rico | 00717-1471 | |
| 163 | Centro Clinico San Patricio | San Juan | Puerto Rico | 00921 | |
| 164 | Miguel Sosa-Padilla, M.D. | San Juan | Puerto Rico | 00926 | |
| 165 | CMI Cardiologie | Baia Mare | Romania | ||
| 166 | Paulescu Institute | Bucharest | Romania | ||
| 167 | Anamed SRL | Oradea | Romania | ||
| 168 | Emergency County Hospital Ploiesti | Ploiesti | Romania | ||
| 169 | Policlinica | Timisoara | Romania | ||
| 170 | Diabetologicka ambulancia | Komarnanska | Velky Meder | Slovakia | 932 01 |
| 171 | Zeleznicne zdravotnictvo s.r.o., Diabetologicka ambulancia | Kosice | Slovakia | 040 01 | |
| 172 | Diabetologicka ambulancia | Nove Mesto nad Vahom | Slovakia | 915 01 | |
| 173 | Diabetologicka ambulancia | Presov | Slovakia | ||
| 174 | Diabetologicka ambulancia | Sahy | Slovakia | 936 01 | |
| 175 | Mestska poliklinika Sered, Diabetologicka ambulancia | Sered | Slovakia | 926 01 | |
| 176 | Diabetologicka ambulancia | Trebisov | Slovakia | 075 01 |
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:
NCT00821977
Other Study ID Numbers:
- CLAF237B2201
First Posted:
Jan 14, 2009
Last Update Posted:
Dec 17, 2020
Last Verified:
May 1, 2012
Keywords provided by Novartis
Additional relevant MeSH terms: