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Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Phase 2 trial testing Mizagliflozin in Postbariatric Hypoglycemia in 9 participants. Completed in 17 February 2023.
| Lead sponsor | Vogenx, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 13 September 2022 |
| Primary completion | 17 February 2023 |
| Estimated completion | 17 February 2023 |
| Sites | 2 locations across United States |
Vogenx, Inc.
Adults 18 to 75, any sex, with Postbariatric Hypoglycemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time course of glucose concentrations during MMTT
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm A | 6.2 | ± 14.8 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm A | 4.0 | ± 17.7 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm B | 17.5 | ± 30.5 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm B | 31.5 | ± 29.0 |
Time frame: 34 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment Arm A Period 1 (… | Treatment Arm A Period 2 (… | Treatment Arm B Period 1 (… | Treatment Arm B Period 2 (… |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Hunger | General disorders | — | — | — | — |
| Infections and infestations | General disorders | — | — | — | — |
| Influenza | General disorders | — | — | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — | — | — |
| Lack of satiety | Metabolism and nutrition disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Taste disorder | Nervous system disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT05541939 adverse events section.
This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05541939.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing