Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glipizide and Metformin · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Glipizide and Metformin HCl Tablets 5 mg/500 mg |
| 2 | ACTIVE_COMPARATOR | Metaglip® Tablets 5 mg/500 mg |
| Name | Type | Description |
|---|---|---|
| Glipizide and Metformin HCl Tablets 5 mg/500 mg | DRUG | 5/500mg, single dose fed |
| Metaglip® Tablets 5 mg/500 mg | DRUG | 5/500mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older 2. Sex: Male and/or non-pregnant, non-lactating female a. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. I...
Glipizide and Metformin is a fixed-dose combination product containing two small molecule active ingredients, glipizide and metformin hydrochloride. It is developed by Viatris Inc., which trades under the ticker VTRS. The listed development stage is Phase 1, and the specific therapeutic indication for this program is undisclosed.
Glipizide and Metformin acts on the molecular targets KCNJ11 and ABCC8. Both targets fall into the blocker class, meaning the drug blocks activity at these sites. KCNJ11 and ABCC8 are the two subunits that together form the ATP-sensitive potassium channel complex.
Viatris Inc., ticker VTRS, is the developer of Glipizide and Metformin. The product is also referenced as Glipizide and Metformin HCl Tablets 5 mg/500 mg, which describes the fixed-dose tablet strength of the combination.
Glipizide and Metformin is in Phase 1 development. Two Phase 1 trials have been completed and none are currently active. The program is investigational, and the available information does not indicate that this combination product has received FDA approval.
Two completed Phase 1 trials have studied Glipizide and Metformin: NCT00649454, a fasting study, and NCT00648505, a food study. Each trial enrolled 36 healthy volunteers in the United States, for a total enrollment of 72 participants. Both were randomized and active controlled, with no double blinding.
Glipizide and Metformin HCl Tablets 5 mg/500 mg was compared against Metaglip Tablets 5 mg/500 mg in both Phase 1 trials, NCT00649454 and NCT00648505. The trials used Metaglip as the active control, so the two products were evaluated side by side rather than being the same study drug.