Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 3B, Multicenter, Open-Label Study Investigating the Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Insulin Therapy
| Verified date | May 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | June 2005 |
| Est. primary completion date | June 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening. - The subject has a HbA1c of 7.0% to 11.0% at Screening. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Anaheim | California |
| United States | Research Site | Arlington | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bloomfield Hills | Michigan |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Escondido | California |
| United States | Research Site | Greenville | North Carolina |
| United States | Research Site | Honolulu | Hawaii |
| United States | Research Site | Idaho Falls | Idaho |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Lakewood | Ohio |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Los Gatos | California |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Moorestown | New Jersey |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Neptune | New Jersey |
| United States | Research Site | New Britain | Connecticut |
| United States | Research Site | New York | New York |
| United States | Research Site | Norwalk | Connecticut |
| United States | Research Site | Norwich | Connecticut |
| United States | Research Site | Olympia | Washington |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Roseland | New Jersey |
| United States | Research Site | San Francisco | California |
| United States | Research Site | Sumter | South Carolina |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Torrance | California |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Vincennes | Indiana |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | Westlake | Ohio |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Wilkes Barre | Pennsylvania |
| United States | Research Site | Williston Park | New York |
| United States | Research Site | Yonkers | New York |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus | To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy. | 6 months | Yes |
| Primary | Understand management issues in subjects with type 1 and type 2 diabetes mellitus | To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy | 6 months | 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 |
NCT02252224 -
Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
|