Type 2 Diabetes Mellitus Clinical Trial
Official title:
Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Evaluate the Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
| Verified date | February 2017 |
| Source | vTv Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to compare the safety and effect of TTP054 versus placebo on glucose control in patients with type 2 diabetes.
| Status | Completed |
| Enrollment | 186 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus - On a stable (for the last 3 months) regimen of either metformin alone or metformin in combination with one additional acceptable oral antidiabetic (OAD) agent - HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - 9.5% Exclusion Criteria: - History or evidence of significant diabetic complications - History of heart attack, stroke or congestive heart failure - Severe, uncontrolled hypertension - Frequent hypoglycemia - Women of child-bearing potential |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 8 | Auburn | Maine |
| United States | Site 18 | Chula Vista | California |
| United States | Site 14 | Cincinnati | Ohio |
| United States | Site 4 | Coral Gables | Florida |
| United States | Site 16 | Dallas | Texas |
| United States | Site 13 | Denver | Colorado |
| United States | Site 3 | Honolulu | Hawaii |
| United States | Site 10 | Houston | Texas |
| United States | Site 2 | Houston | Texas |
| United States | Site 17 | Indianapolis | Indiana |
| United States | Site 11 | Katy | Texas |
| United States | Site 9 | Las Vegas | Nevada |
| United States | Site 1 | Los Angeles | California |
| United States | Site 7 | Louisville | Kentucky |
| United States | Site 6 | Mount Pleasant | South Carolina |
| United States | Site 5 | Port Orange | Florida |
| United States | Site 15 | Richmond | Virginia |
| United States | Site 12 | Rochester | New York |
| United States | Site 26 | Trenton | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| vTv Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in HbA1c (%) as compared to placebo | Day 1 to Day 84 | ||
| Secondary | Change from baseline in fasting plasma glucose (mg/dL) | Day 1, Day 14, Day 28, Day 56 and Day 84 | ||
| Secondary | Subject achievement of HbA1c <7% | Day 84 | ||
| Secondary | Change from baseline in body weight | Day 1, Day 14, Day 28, Day 56 and Day 84 | ||
| Secondary | Subject achievement of body weight loss = 2% | Day 1 and Day 84 |
| 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 |