Trial Outcomes & Findings for Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects (NCT NCT05541939)
NCT ID: NCT05541939
Last Updated: 2024-06-25
Results Overview
Time course of glucose concentrations during MMTT
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
0-3 hours following liquid meal
Results posted on
2024-06-25
Participant Flow
9 participants were screened between September 2022 and January 2023. 7 participants at University of Colorado/Anschutz Medical Campus and 2 participants at Stanford.University
All 9 screened participants met eligibility criteria and were randomized
Participant milestones
| Measure |
Treatment Arm A
Randomized participants received a Baseline MMTT. After approximately 7 days the participants returned to the clinic for Period 1 treatment, a single 2.5 mg capsule of mizagliflozin, followed by an MMTT. After a 7-day washout, participants returned to the clinic for Period 2 treatment, a single 5.0 mg capsule of mizagliflozin, followed by an MMTT.
|
Treatment Arm B
Randomized participants received a Baseline MMTT. After approximately 7 days the participants returned to the clinic for Period 1 treatment, a single 2.5 mg liquid formulation of mizagliflozin, followed by an MMTT. After a 7-day washout, participants returned to the clinic for Period 2 treatment, a single 10.0 mg capsule of mizagliflozin, followed by an MMTT.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Mizagliflozin on Postprandial Glucose and Insulin in Post-Bariatric Hypoglycemia Subjects
Baseline characteristics by cohort
| Measure |
Treatment Arm A
n=5 Participants
Randomized participants received a Baseline MMTT. After approximately 7 days the participants returned to the clinic for Period 1 treatment, a single 2.5 mg capsule of mizagliflozin, followed by an MMTT. After a 7-day washout, participants returned to the clinic for Period 2 treatment, a single 5.0 mg capsule of mizagliflozin, followed by an MMTT.
Mizagliflozin: Encapsulated
|
Treatment Arm B
n=4 Participants
Randomized participants received a Baseline MMTT. After approximately 7 days the participants returned to the clinic for Period 1 treatment, a single 2.5 mg liquid formulation of mizagliflozin, followed by an MMTT. After a 7-day washout, participants returned to the clinic for Period 2 treatment, a single 10.0 mg capsule of mizagliflozin, followed by an MMTT.
Mizagliflozin: Encapsulated or Liquid Formulation
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline MMTT (pharmacodynamic assessment for glucose and insulin)
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0-3 hours following liquid mealPopulation: Change from Baseline MMTT in Glucose Nadir (mg/dL)
Time course of glucose concentrations during MMTT
Outcome measures
| Measure |
Treatment Arm A
n=5 Participants
Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin
Mizagliflozin: Encapsulated
|
Treatment Arm B
n=4 Participants
Subjects will receive a single dose of liquid formulation (Period 1) and a single dose of encapsulated (Period 2)
|
|---|---|---|
|
Glucose Nadir After Mizagliflozin Dosing
2.5 mg Capsule
|
6.2 mg/dL
Standard Deviation 14.8
|
—
|
|
Glucose Nadir After Mizagliflozin Dosing
5.0 mg Capsule
|
4.0 mg/dL
Standard Deviation 17.7
|
—
|
|
Glucose Nadir After Mizagliflozin Dosing
2.5 mg Liquid
|
—
|
17.5 mg/dL
Standard Deviation 30.5
|
|
Glucose Nadir After Mizagliflozin Dosing
10.0 mg Capsule
|
—
|
31.5 mg/dL
Standard Deviation 29.0
|
Adverse Events
Treatment Arm A Period 1 (2.5 mg Capsule)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment Arm A Period 2 (5.0 mg Capsule)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Arm B Period 1 (2.5 mg Liquid Formulation)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment Arm B Period 2 (10.0 mg Capsule)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Arm A Period 1 (2.5 mg Capsule)
n=5 participants at risk
Subjects will receive a single 2.5 mg capsule
Mizagliflozin: Encapsulated
|
Treatment Arm A Period 2 (5.0 mg Capsule)
n=5 participants at risk
Subjects will receive a single 5.0 mg capsule
Mizagliflozin: Encapsulated
|
Treatment Arm B Period 1 (2.5 mg Liquid Formulation)
n=4 participants at risk
Subjects will receive a single 2.5 mg liquid formulation
Mizagliflozin: Liquid Formulation
|
Treatment Arm B Period 2 (10.0 mg Capsule)
n=4 participants at risk
Subjects will receive a single 10.0 mg capsule
Mizagliflozin: Encapsulated
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 2 • 34 Days
|
0.00%
0/5 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • 34 Days
|
0.00%
0/5 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/5 • 34 Days
|
0.00%
0/4 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • 34 Days
|
0.00%
0/5 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2 • 34 Days
|
0.00%
0/5 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/5 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
General disorders
Hunger
|
0.00%
0/5 • 34 Days
|
0.00%
0/5 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
General disorders
Infections and infestations
|
0.00%
0/5 • 34 Days
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
General disorders
Influenza
|
0.00%
0/5 • 34 Days
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/5 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Number of events 2 • 34 Days
|
0.00%
0/5 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Metabolism and nutrition disorders
Lack of satiety
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/5 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/5 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/5 • 34 Days
|
25.0%
1/4 • Number of events 1 • 34 Days
|
0.00%
0/4 • 34 Days
|
|
Nervous system disorders
Taste disorder
|
20.0%
1/5 • Number of events 1 • 34 Days
|
0.00%
0/5 • 34 Days
|
0.00%
0/4 • 34 Days
|
0.00%
0/4 • 34 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60