Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety And Efficacy Of PF-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin
| Verified date | April 2014 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes
| Status | Completed |
| Enrollment | 345 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female Exclusion Criteria: - patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hungary | Pfizer Investigational Site | Balatonfured | |
| Hungary | Pfizer Investigational Site | Bekescsaba | |
| Hungary | Pfizer Investigational Site | Budapest | |
| Hungary | Pfizer Investigational Site | Debrecen | |
| Hungary | Pfizer Investigational Site | Debrecen | |
| Hungary | Pfizer Investigational Site | Gyor | |
| Hungary | Pfizer Investigational Site | Polgar | |
| Hungary | Pfizer Investigational Site | Szeged | |
| Hungary | Pfizer Investigational Site | Zalaegerszeg | |
| India | Pfizer Investigational Site | Jaipur | Rajasthan |
| India | Pfizer Investigational Site | Mumbai | Maharashtra |
| India | Pfizer Investigational Site | Mumbai | Maharashtra |
| India | Pfizer Investigational Site | Pune | Maharashtra |
| Philippines | Pfizer Investigational Site | Cebu City | |
| Philippines | Pfizer Investigational Site | Marikina City | |
| Philippines | Pfizer Investigational Site | Pasig City | |
| Romania | Pfizer Investigational Site | Bucuresti | |
| Romania | Pfizer Investigational Site | Bucuresti | |
| Romania | Pfizer Investigational Site | Cluj-Napoca | Jud. Cluj |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Lucenec | |
| Slovakia | Pfizer Investigational Site | Nitra | |
| Slovakia | Pfizer Investigational Site | Nove Mesto nad Vahom | |
| Slovakia | Pfizer Investigational Site | Presov | |
| Slovakia | Pfizer Investigational Site | Trebisov | |
| Slovakia | Pfizer Investigational Site | Trencin | |
| South Africa | Pfizer Investigational Site | Bloemfontein | Free State |
| South Africa | Pfizer Investigational Site | Durban | |
| South Africa | Pfizer Investigational Site | Johannesburg | Gauteng |
| South Africa | Pfizer Investigational Site | Kimberley | Northern Cape |
| South Africa | Pfizer Investigational Site | Midrand | Gauteng |
| South Africa | Pfizer Investigational Site | Moloto | |
| South Africa | Pfizer Investigational Site | Pretoria | Gauteng |
| South Africa | Pfizer Investigational Site | Waverley | Gauteng |
| Taiwan | Pfizer Investigational Site | Changhua City | |
| Taiwan | Pfizer Investigational Site | New Taipei City | |
| Taiwan | Pfizer Investigational Site | Taichung | |
| Taiwan | Pfizer Investigational Site | Tainan | |
| United States | Pfizer Investigational Site | Anaheim | California |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Belleview | Florida |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Conyers | Georgia |
| United States | Pfizer Investigational Site | Fargo | North Dakota |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Kettering | Ohio |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Meridian | Idaho |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Mount Sterling | Kentucky |
| United States | Pfizer Investigational Site | Ocala | Florida |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Paramus | New Jersey |
| United States | Pfizer Investigational Site | Plano | Texas |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Spring Valley | California |
| United States | Pfizer Investigational Site | Sugar Land | Texas |
| United States | Pfizer Investigational Site | Tomball | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Hungary, India, Philippines, Romania, Slovakia, South Africa, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HbA1C - change from baseline | 84-days | No | |
| Secondary | Fasting plasma glucose - change from baseline | 84-days | No | |
| Secondary | Adverse events | 84-days | Yes | |
| Secondary | Vitals - systolic blood pressure (SBP), diastolic blood pressue (DBP), heart rate | 84-days | Yes | |
| Secondary | 12-lead electrocardiograms (ECGs) | 84-days | Yes | |
| Secondary | Body weight | 84-days | Yes | |
| Secondary | Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysis | 84-days | Yes |
| 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 |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|