Maximal Glucagon Concentration During Hypoglycemia
| Group | Value (pg/mL) | Spread |
|---|---|---|
| T1D on MBX-2982 | 19.9 | 12.6 |
| T1D on Placebo | 22.5 | 16.8 |
| Healthy Normal Volunteers | 82.7 | 39.7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataShort name PHROG
This trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to test if a specific research medication could increase the response to low blood glucose in people with type 1 diabetes. The response of the body to low blood sugar will be measured in healthy people as a reference point.
Experimental
MBX-2982 first then placebo- Volunteers with Type 1 diabetes
Participants with type 1 diabetes (T1D) will be randomized to either study medication or placebo group. 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).
Active comparator
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.
Experimental
Placebo first then MBX-2982- Volunteers with Type 1 diabetes
Participants with type 1 diabetes (T1D) will be randomized to either study medication or placebo group. 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).
Outcomes the sponsor listed as primary.
Maximal Glucagon Concentration During Hypoglycemia
Time frame · Day 14, Day 42
Maximal glucagon concentration during insulin induced hypoglycemia. This was measured during the hypoglycemic steady state of the hyper-insulinemic euglycemic-hypoglycemic clamp study.
Total Area Under the Curve (AUC) for Glucagon During Hypoglycemia.
Time frame · Day 14, Day 42
This 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.
Incremental AUC for Glucagon During Hypoglycemia (Above Baseline Levels During Euglycemia)
Time frame · Day 14, Day 42
This 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)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (pg/mL) | Spread |
|---|---|---|
| T1D on MBX-2982 | 19.9 | 12.6 |
| T1D on Placebo | 22.5 | 16.8 |
| Healthy Normal Volunteers | 82.7 | 39.7 |
| Group | Value (pg*min/mL) | Spread |
|---|---|---|
| T1D on MBX-2982 | 6624.6 | 3772.4 |
| T1D on Placebo | 6037.5 | 3545.9 |
| Healthy Normal Volunteers | 15923.2 | 5350.6 |
| Group | Value (pg*min/mL) | Spread |
|---|---|---|
| T1D on MBX-2982 | 327.9 | 257.9 |
| T1D on Placebo | 467.8 | 435.7 |
| Healthy Normal Volunteers | 2445.4 | 1346.4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| T1D on MBX-2982Participants with type 1 diabetes (T1D) who were randomized to the study drug, MBX-2982 | 0 / 18 | 0 / 18 | 4 / 18 |
| T1D on PlaceboParticipants with type 1 diabetes (T1D) who were randomized to placebo | 0 / 18 | 0 / 18 | 5 / 18 |
| Healthy Normal VolunteersParticipants enrolled in this group had no T1D and were not randomized to drug or placebo | 0 / 9 | 0 / 9 | 0 / 9 |
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