Trial Outcomes & Findings for GPR119 Agonist for Hypoglycemia in Type 1 Diabetes (NCT NCT04432090)
NCT ID: NCT04432090
Last Updated: 2024-10-17
Results Overview
Maximal glucagon concentration during insulin induced hypoglycemia. This was measured during the hypoglycemic steady state of the hyper-insulinemic euglycemic-hypoglycemic clamp study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Day 14, Day 42
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
MBX-2982 First Then Placebo- Volunteers With Type 1 Diabetes
In this arm, participants will receive a pill that contains the study medication (MBX-2982). This will be followed by a wash-out period and a cross over to the second study period in which they will receive a pill that does not contain the medication (placebo).
|
Placebo First Then MBX-2982- Volunteers With Type 1 Diabetes
In this arm, participants will receive a pill that does not contain the medication (placebo). This will be followed by a wash-out period and a cross over to the second study period in which they will receive a pill that contains the study medication (MBX-2982).
|
Healthy Volunteers
This group will not receive any medication. It will be studied to establish the norm of the measurement that will be performed to obtain the study outcomes.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
46
|
|
Overall Study
Randomized
|
13
|
14
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
23
|
23
|
37
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GPR119 Agonist for Hypoglycemia in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Type 1 Diabetes on MBX-2982 or Placebo
n=18 Participants
Each group will be randomized to receive either a pill that contains the study medication (MBX-2982) or a pill that does not contain the medication (placebo)
This will be followed by a second study period in which they will be crossed over to the other treatment.
|
Healthy Volunteers
n=9 Participants
This group will not receive any medication. It will be studied to establish the norm of the measurement that will be performed to obtain the study outcomes.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
38.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Weight
|
74.4 Kilograms
STANDARD_DEVIATION 13.4 • n=5 Participants
|
73.1 Kilograms
STANDARD_DEVIATION 12.1 • n=7 Participants
|
74.0 Kilograms
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Body mass index
|
25.6 kg/m2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
25.4 kg/m2
STANDARD_DEVIATION 2.5 • n=7 Participants
|
25.5 kg/m2
STANDARD_DEVIATION 3.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14, Day 42Maximal glucagon concentration during insulin induced hypoglycemia. This was measured during the hypoglycemic steady state of the hyper-insulinemic euglycemic-hypoglycemic clamp study.
Outcome measures
| Measure |
T1D on MBX-2982
n=18 Participants
Participants with type 1 diabetes (T1D) who were randomized to the study drug, MBX-2982
|
T1D on Placebo
n=18 Participants
Participants with type 1 diabetes (T1D) who were randomized to placebo
|
Healthy Normal Volunteers
n=9 Participants
Participants enrolled in this group had no T1D and were not randomized to drug or placebo
|
|---|---|---|---|
|
Maximal Glucagon Concentration During Hypoglycemia
|
19.9 pg/mL
Standard Deviation 12.6
|
22.5 pg/mL
Standard Deviation 16.8
|
82.7 pg/mL
Standard Deviation 39.7
|
PRIMARY outcome
Timeframe: Day 14, Day 42This outcome was measured during the hypoglycemic steady state of the hyper-insulinemic euglycemic hypoglycemic clamp study. Total area under the curve (AUC) for glucagon was measured during the time points of 120 minutes to 140 minutes of the clamp.
Outcome measures
| Measure |
T1D on MBX-2982
n=18 Participants
Participants with type 1 diabetes (T1D) who were randomized to the study drug, MBX-2982
|
T1D on Placebo
n=17 Participants
Participants with type 1 diabetes (T1D) who were randomized to placebo
|
Healthy Normal Volunteers
n=9 Participants
Participants enrolled in this group had no T1D and were not randomized to drug or placebo
|
|---|---|---|---|
|
Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia.
|
6624.6 pg*min/mL
Standard Deviation 3772.4
|
6037.5 pg*min/mL
Standard Deviation 3545.9
|
15923.2 pg*min/mL
Standard Deviation 5350.6
|
PRIMARY outcome
Timeframe: Day 14, Day 42This is the difference between the AUC during the hypoglycemic steady state (time points 120 - 140 mins of clamp) and the baseline glucagon levels during euglycemic steady state (timepoints 60 min - 80 mins of the clamp)
Outcome measures
| Measure |
T1D on MBX-2982
n=18 Participants
Participants with type 1 diabetes (T1D) who were randomized to the study drug, MBX-2982
|
T1D on Placebo
n=17 Participants
Participants with type 1 diabetes (T1D) who were randomized to placebo
|
Healthy Normal Volunteers
n=9 Participants
Participants enrolled in this group had no T1D and were not randomized to drug or placebo
|
|---|---|---|---|
|
Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia)
|
327.9 pg*min/mL
Standard Deviation 257.9
|
467.8 pg*min/mL
Standard Deviation 435.7
|
2445.4 pg*min/mL
Standard Deviation 1346.4
|
Adverse Events
T1D on Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy Normal Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T1D on MBX-2982
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
T1D on Placebo
n=18 participants at risk
Participants with type 1 diabetes (T1D) who were randomized to placebo
|
Healthy Normal Volunteers
n=9 participants at risk
Participants enrolled in this group had no T1D and were not randomized to drug or placebo
|
T1D on MBX-2982
n=18 participants at risk
Participants with type 1 diabetes (T1D) who were randomized to the study drug, MBX-2982
|
|---|---|---|---|
|
General disorders
Headache
|
27.8%
5/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
11.1%
2/18 • Adverse events were collected from screening visit till end of study (day 49).
|
|
Gastrointestinal disorders
Nausea, vomiting
|
11.1%
2/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
11.1%
2/18 • Adverse events were collected from screening visit till end of study (day 49).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
11.1%
2/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
5.6%
1/18 • Adverse events were collected from screening visit till end of study (day 49).
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/18 • Adverse events were collected from screening visit till end of study (day 49).
|
|
General disorders
Palpitations
|
5.6%
1/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/18 • Adverse events were collected from screening visit till end of study (day 49).
|
|
Musculoskeletal and connective tissue disorders
Exacerbation of capsulitis
|
0.00%
0/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
5.6%
1/18 • Adverse events were collected from screening visit till end of study (day 49).
|
|
Musculoskeletal and connective tissue disorders
swelling of hand
|
5.6%
1/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/18 • Adverse events were collected from screening visit till end of study (day 49).
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
5.6%
1/18 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/9 • Adverse events were collected from screening visit till end of study (day 49).
|
0.00%
0/18 • Adverse events were collected from screening visit till end of study (day 49).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place