Drugs / GK1-399
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT01474083 | Nov 2011 → Aug 2012 | type 2 diabetes mellitus | vTv Therapeutics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2022-06-04 | vTv Therapeutics | Results vTv Therapeutics Announces Publication in Diabetes Obesity and Metabolism of Complete Results for the Mechanistic Study Assessing Effects of TTP399 on Ketones during Acute Insulin Withdrawal in Patients with Type 1 Diabetes vtvtherapeutics.com ↗
No subject treated with TTP399 met the prespecified definition of DKA while 42% of placebo-treated subjects met this criterion. |
| 2021-10-12 | vTv Therapeutics | Results vTv Therapeutics Announces Positive Results from Mechanistic Study Indicating No Increased Risk of Ketoacidosis with TTP399 during Acute Insulin Withdrawal in Patients with Type 1 Diabetes vtvtherapeutics.com ↗
The study demonstrated that patients with T1D taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating no increased risk of ketoacidosis. |
| 2021-04-13 | vTv Therapeutics | Regulatory vTv Therapeutics Receives FDA Breakthrough Therapy Designation for TTP399 for the Treatment of Type 1 Diabetes vtvtherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes. |
| 2021-02-23 | vTv Therapeutics | Results vTv Therapeutics Announces Publication in Diabetes Care of Results from SimpliciT-1 Study of TTP399 in Patients with Type 1 Diabetes vtvtherapeutics.com ↗
Published results from the study showed that treatment with 800mg of TTP399 demonstrated statistically significant reductions in HbA1c, as previously announced. |
| 2020-09-23 | vTv Therapeutics | Results vTv Therapeutics Presents Additional Positive Clinical Study Results Supporting the Safety and Efficacy of TTP399 as Adjunctive Therapy in Patients with Type 1 Diabetes vtvtherapeutics.com ↗
The company also presented additional data from the Simplici-T1 study confirming that treatment with TTP399 resulted in significant improvements in HbA1c, with reduction in bolus insulin dose, without increasing the risk of hypoglycemia or DKA. |
| 2020-06-13 | vTv Therapeutics | Results vTv Therapeutics Presents Two Late-Breaking Poster Sessions on Simplici-T1 Study at the American Diabetes Association’s Virtual Sessions Supporting the Potential of TTP399 as First-in-Class Oral Adjunctive Therapy for Type 1 Diabetes Patients vtvtherapeutics.com ↗
The clinical data presented from the positive Phase 2 Simplici-T1 Study confirms the potential for TTP399 to provide a benefit beyond standalone insulin treatment for patients living with type 1 diabetes. |
| 2020-02-10 | vTv Therapeutics | Results vTv Therapeutics Announces Positive Results from Part 2 of the Phase 2 Simplici-T1 Study of TTP399, Potential First-in-Class Oral Adjunctive Therapy for Patients with Type 1 Diabetes vtvtherapeutics.com ↗
Under the primary statistical analysis, the trial achieved its primary objective by demonstrating statistically significant improvements in HbA1c (long-term blood sugar) for TTP399 compared to placebo at week 12 (p=0.03). |
| 2019-09-18 | vTv Therapeutics | Results vTv Therapeutics Presents Additional Positive Data from the Phase 2 Simplici-T1 Study in Patients with Type 1 Diabetes at 55th Annual Meeting of the European Association for the Study of Diabetes vtvtherapeutics.com ↗
TTP399 treatment reduced the total daily mealtime bolus insulin dose by 23% compared to 4% for placebo while significantly improving glycemic control. |
| 2019-06-06 | vTv Therapeutics | Results vTv Therapeutics Announces Positive Topline Results from Part 1 of the Phase 2 Simplici-T1 Trial in Patients with Type 1 Diabetes vtvtherapeutics.com ↗
vTv Therapeutics Inc. (Nasdaq: VTVT) today announced positive results from the primary analysis of Part 1 of the Phase 2 Simplici-T1 trial assessing the liver-selective glucokinase activator TTP399 in adult patients with type 1 diabetes (T1D). |
| 2019-01-16 | vTv Therapeutics | Results vTv Therapeutics Announces Publication of Comprehensive Data in Science Translational Medicine Detailing the Discovery and Clinical Development of TTP399, including Results of Phase 2 AGATA Study vtvtherapeutics.com ↗
In this 6-month study, TTP399 (800 mg/day) was associated with a statistically significant and sustained reduction in glycated hemoglobin, with a placebo-subtracted least squares mean HbA1c change from baseline of −0.9% (p< 0.01). |
| 2018-03-22 | vTv Therapeutics | Results vTv Therapeutics Announces Completion of Phase 1b Study Evaluating TTP399 for the Treatment of Type 1 Diabetes vtvtherapeutics.com ↗
Results showed that TTP399 was found to be well-tolerated and improved or maintained glycemic control while reducing or simplifying an insulin regimen. |
| 2016-08-10 | vTv Therapeutics | Results CORRECTING and REPLACING vTv Therapeutics Announces Positive Topline Results from Phase 2b Study of Glucokinase Activator TTP399 in Type 2 Diabetes vtvtherapeutics.com ↗
Topline results showed achievement of the primary endpoint of statistically significant change from baseline in HbA1c at 6 months of daily administration of 800 mg of TTP399. |
| 2013-08-14 | vTv Therapeutics | Results First Liver-Selective Glucokinase Activator for Type 2 Diabetes Demonstrates Normalized HbA1c and No Hypoglycemia in Clinical Trial vtvtherapeutics.com ↗
TTP399, a novel, liver-selective glucokinase activator (GKA), demonstrated clinical evidence of normalizing HbA 1c without inducing hypoglycemia in type 2 diabetic subjects on stable doses of metformin. |
All press releases naming this drug 23 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GK1-399 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01474083 ↗ |
| Known as | TTP399 | “GK1-399 (formerly TTP399)” NCT01474083 ↗ |
| Route | Oral | “Oral administration, twice per day.” NCT01474083 ↗ |