Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of INT131 Besylate Compared to Pioglitazone in Subjects With Type 2 Diabetes
| Verified date | August 2010 |
| Source | InteKrin Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.
| Status | Completed |
| Enrollment | 367 |
| Est. completion date | September 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose - Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age - HbA1c must be =7.5% and =10% at screening - Fasting Plasma Glucose must be <240 mg/dL at screening Exclusion Criteria: - History of type 1 diabetes - History of diabetic ketoacidosis - NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1 - Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening - Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening - Body mass index >45 kg/m2 - Fasting triglycerides >500 mg/dL - Uncontrolled hypertension (sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg - Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Unidad Metabolica y Cardiovascular SC | Cuernavaca | Morelos |
| Mexico | Nucleo Medico Vallarta | Guadalajara | Jalisco |
| Mexico | Centro Especializado en Diabetes y Obisidad (EDOPEC) | Mexico City | Mexico DF |
| Mexico | Comite Mexicano para la Prevencion de la Osteoporosis A.C. | Mexico City | Mexico DF |
| Mexico | Instituto Mexicano de Investigacion Clinica | Mexico City | Mexico DF |
| Mexico | Instituto Nacional de Nutricion Salvador Zubiran (INNSZ) | Mexico City | Mexico DF |
| Mexico | Hospital Santa Engracia | Monterrey | Nuevo Leon |
| United States | Hartwell Research Group | Anderson | South Carolina |
| United States | Executive Health and Research Associates, Inc. | Atlanta | Georgia |
| United States | Stephen R. Smith, MD | Baltimore | Maryland |
| United States | Tri-State Medical Group, Inc. | Beaver | Pennsylvania |
| United States | Comprehensive Clinical Research | Berlin | New Jersey |
| United States | Bozeman Deaconess Internal Medicine Associates | Bozeman | Montana |
| United States | Kaleida Health Diabetes Center | Buffalo | New York |
| United States | Northern California Research | Carmichael | California |
| United States | Medical Research South | Charleston | South Carolina |
| United States | Diabetes and Endocrinology Specialists, Inc. | Chesterfield | Missouri |
| United States | Cedar-Crosse Research Center | Chicago | Illinois |
| United States | ICCT Reseach International | Chicago | Illinois |
| United States | IVA Research | Cincinnati | Ohio |
| United States | The Lindner Clinical Trial Center | Cincinnati | Ohio |
| United States | Rapid Medical Research, Inc | Cleveland | Ohio |
| United States | Internal Medicine of the Rockies | Colorado Springs | Colorado |
| United States | Opitmed Research, LTD | Columbus | Ohio |
| United States | Clinical Research of South Florida | Coral Gables | Florida |
| United States | New England Center for Clinical Research | Cranston | Rhode Island |
| United States | ResEvo LLC | Cuyahoga Falls | Ohio |
| United States | Baylor University Endocrine Center | Dallas | Texas |
| United States | Dallas Diabetes and Endocrine Research Center | Dallas | Texas |
| United States | Research Institute of Dallas | Dallas | Texas |
| United States | Delaware Smith Clinic | Delaware | Ohio |
| United States | Creekside Endocrine Associates, PC | Denver | Colorado |
| United States | UNC Diabetes Care Center/Highgate Specialty Center | Durham | North Carolina |
| United States | Prestige Clinical Research | Franklin | Ohio |
| United States | Fairbrook Medical Clinic | Hickory | North Carolina |
| United States | The Center for Diabetes and Endocrine Care | Hollywood | Florida |
| United States | American Health Network | Indianapolis | Indiana |
| United States | Lycoming Internal Medicine, Inc. | Jersey Shore | Pennsylvania |
| United States | Saint Luke's Lipid and Diabetes Reseach Center | Kansas City | Missouri |
| United States | Wells Institute for Health Awareness | Kettering | Ohio |
| United States | National Research Institute | Los Angeles | California |
| United States | L-Marc Research Center | Louisville | Kentucky |
| United States | Frederick C Smith Clinic | Marion | Ohio |
| United States | Your Diabetes Endocrine Nutrition Group, LLC | Mentor | Ohio |
| United States | Baptist Diabetes Associates, PA | Miami | Florida |
| United States | Elite Research Institute | Miami | Florida |
| United States | International Research Associates, LLC | Miami | Florida |
| United States | Diabetes Center of the Southwest | Midland | Texas |
| United States | Clinical Research Consulting, LLC | Milford | Connecticut |
| United States | Diabetes & Endrocrinology Consultants | Morehead City | North Carolina |
| United States | New Orleans Center for Clinical Research | New Orleans | Louisiana |
| United States | Suncoast Clinical Research, Inc. | New Port Richey | Florida |
| United States | Olive Branch Family Medical Center | Olive Branch | Mississippi |
| United States | Suncoast Clinical Research, Inc. | Palm Harbor | Florida |
| United States | Clinical Research Source, Inc | Perrysburg | Ohio |
| United States | Endocrine Research Solutions, Inc. | Roswell | Georgia |
| United States | Salem VA Medical Center R&D Office | Salem | Virginia |
| United States | DGD Research | San Antonio | Texas |
| United States | Quality Research, Inc. | San Antonio | Texas |
| United States | VA San Diego Healthcare System | San Diego | California |
| United States | Apex Research Institute | Santa Ana | California |
| United States | Palmetto Clinical Trial Services, LLC | Simpsonville | South Carolina |
| United States | Meridien Research | Tampa | Florida |
| United States | Meridien Research | Tampa | Florida |
| United States | MedStar Research Institute | Washington | District of Columbia |
| United States | Clinical Research of Central Florida | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| InteKrin Therapeutics, Inc. |
United States, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward | HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent | Weeks 0-24 | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward. | The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward. | Weeks 0-24 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02771093 -
An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT02545842 -
Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)
|
Phase 4 | |
| Recruiting |
NCT03436212 -
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.
|
N/A | |
| Completed |
NCT03244800 -
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
|
Phase 2 | |
| Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
| Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
| Recruiting |
NCT06065540 -
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
|
Phase 3 | |
| Recruiting |
NCT05008276 -
Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
|
||
| Completed |
NCT04091373 -
A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide
|
Phase 1 | |
| Completed |
NCT03296800 -
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06212778 -
Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
|
||
| Completed |
NCT05979519 -
Fresh Carts for Mom's to Improve Food Security and Glucose Management
|
N/A | |
| Recruiting |
NCT05579314 -
XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Terminated |
NCT03684642 -
Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
|
Phase 3 | |
| Completed |
NCT03248401 -
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT03644134 -
A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns
|
N/A | |
| Completed |
NCT05295160 -
Fasting-Associated Immune-metabolic Remission of Diabetes
|
N/A | |
| Completed |
NCT02836873 -
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
|
Phase 3 | |
| Completed |
NCT02226003 -
Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
|
Phase 3 |