Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm A Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin |
Drug: Mizagliflozin
Encapsulated or Liquid Formulation
|
| Experimental: Treatment Arm B Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2) |
Drug: Mizagliflozin
Encapsulated or Liquid Formulation
|
Outcome Measures
Primary Outcome Measures
- Adverse Events [Through study completion, 34 days]
Number of participants with Adverse events
- Vital Signs [Through study completion, 34 days]
Number of participants with abnormal vital signs
- Laboratory Tests [Through study completion, 34 days]
Number of participants with abnormal laboratory tests
- Electrocardiograms [Through study completion, 34 days]
Number of participants with abnormal electrocardiograms
- Peak plasma glucose concentration after mizagliflozin dosing. [0-6 hours following liquid meal]
Time course of glucose concentrations during MMTT
- Peak insulin concentration after mizagliflozin dosing [0-6 hours following liquid meal]
Time course of insulin concentrations during MMTT
Secondary Outcome Measures
- MMTT time to peak plasma glucose concentration after mizagliflozin dosing [0-6 hours following liquid meal]
Time course of glucose concentrations during MMTT
- MMTT plasma glucose concentration [0-6 hours following liquid meal]
MMTT plasma glucose area under the curve (AUC0-1, AUC0-2, AUC0-3, AUC0-4, and AUC0-6) after mizagliflozin dosing
- MMTT time to peak insulin concentration after mizagliflozin dosing [0-6 hours following liquid meal]
Time course of insulin concentrations during MMTT
- MMTT insulin concentration [0-6 hours following liquid meal]
MMTT insulin concentrations area under the curve (AUC0-1, AUC0-2, AUC0-3, AUC0-4, and AUC0-6) after mizagliflozin dosing
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
-
Diagnosis of PBH
Exclusion Criteria:
-
History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
-
Current use of insulin or insulin secretagogues.
-
History of current dumping syndrome.
-
History of current fasting hypoglycemia.
-
Pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado / Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- Vogenx, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VGX-001-011