DIABETA (glyburide)
DIABETA is indicated for the treatment of Type 2 Diabetes.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1984-05-01
- Routes
- ORAL
- Dosage Forms
- TABLET
DIABETA Approval History
What DIABETA Treats
1 indicationsDIABETA is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
DIABETA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DIABETA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DIABETA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DIABETA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01329016 GDM | 820 | Ph 1, Ph 2 | completed | Glyburide and Metformin for Gestational Diabetes Mellitus (GDM) |
| NCT01731431 INDAO | P110104 | Ph 3 | completed | Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes |
| NCT03029702 MATCh-GDM results posted | PRO16100499 K23HD092893 | Ph 4 | completed | Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus |
| NCT01454154 | RPI 202 INTRuST-GLY | Ph 2 | completed | Glyburide (RP-1127) for Traumatic Brain Injury (TBI) |
| NCT02460874 results posted | IRB-16063003 | Ph 1, Ph 2 | terminated | Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593) |
| NCT02524379 SCING results posted | 2014H0335 | Ph 1, Ph 2 | terminated | Spinal Cord Injury Neuroprotection With Glyburide |
| NCT00744965 results posted | 032011-086 042008-058 | Ph 4 | completed | Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo |
| NCT03856970 | C3718-103 | Ph 1 | completed | Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers |
| NCT03078725 GLAM | HSC-MS-16-1052 | Ph 4 | withdrawn | Failure Rate of GLyburide And Metformin Among Gestational Diabetics |
| NCT02815787 | QLHCPI-179 | Ph 1 | completed | The Drug -Drug Interaction of SP2086 and Glyburide |
| NCT01947699 | UPMC_GLY_GDM | Ph 4 | withdrawn | Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide |
| NCT00935363 | GlyburideOATP2C9 | Ph 1 | withdrawn | Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK) |
| NCT01716338 | A-15112.b | Ph 1 | completed | Glyburide Healthy Volunteer Study |
| NCT02183428 | 1218.30 | Ph 1 | completed | Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers |
| NCT01456650 | INNSZ-ABCA1 | Ph 4 | completed | R230C and C230C Variants of ABCA1 and Glyburide Response |
| NCT01733108 | CR014872 28431754DIA1004 | Ph 1 | completed | A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers |
| NCT01029795 results posted | 13272 I2Q-MC-GMAJ | Ph 2 | terminated | A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DIABETA FDA Label Details
Indications & Usage
FDA Label (PDF)DIABETA is indicated for the treatment of Type 2 Diabetes.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment