Trial Outcomes & Findings for Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes (NCT NCT04079881)
NCT ID: NCT04079881
Last Updated: 2022-10-07
Results Overview
Glucagon levels done fasting, 30, 60, 120, and 180 minutes
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
4 hours
Results posted on
2022-10-07
Participant Flow
Only one participant enrolled. Each participant acted as their own control. One participant completed arm A:B.
Participant milestones
| Measure |
A (Pre-prandial Insulin Administration) : B (Post-prandial Insulin Administration)
Visit 1: will receive short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal. Visit 2: will receive short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal.
Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
|
B: (Post-prandial Insulin Administration): A (Pre-prandial Insulin Administration)
Visit 1: will receive short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal Visit 2: will receive short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
A (Pre-prandial Insulin Administration) / (Post-prandial Insulin Administration)
n=1 Participants
Visit 1: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal. Visit 2: will give short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal.
Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
|
B (Post-prandial Insulin Administration) / (Pre-prandial Insulin Administration)
Visit 1: will give short action insulin (Humalog, Lispro, etc.) with the same regiment patient was using at home 20 minutes after the meal; Visit 2: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal.
Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
|
Total
n=1 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
0 Participants
n=107 Participants
|
0 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
|
HbA1c
|
8.2 percent of glycated hemoglobin
n=99 Participants
|
—
|
8.2 percent of glycated hemoglobin
n=206 Participants
|
|
cPeptide
|
0.003 ng/mL
n=99 Participants
|
—
|
0.003 ng/mL
n=206 Participants
|
|
A: Baseline fasting blood glucose (BG)
|
193 mg/dL
n=99 Participants
|
—
|
193 mg/dL
n=206 Participants
|
|
Visit B - Baseline Fast Blood Glucose
|
171 mg/dL
n=99 Participants
|
—
|
171 mg/dL
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: Study was delayed and then terminated due to COVID pandemic, funding was lost so primary analysis was not performed.
Glucagon levels done fasting, 30, 60, 120, and 180 minutes
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 hours* Glucose done fasting, 30, 60, 120, and 180 minutes * Glucagon levels done fasting, 30, 60, 120, and 180 minutes * Usual insulin dose will be administered 20 minutes before or after the mixed meal challenge with Ensure Plus\*
Outcome measures
| Measure |
Pre-prandial Insulin Administration
n=1 Participants
Pre-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min prior the meal.
Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
|
Post-prandial Insulin Administration
n=1 Participants
Post-prandial insulin: will give short acting insulin (Humalog, Lispro, etc) with the same regimen patient was using at home 20 min post the meal.
Insulin: to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
|
|---|---|---|
|
AUC Postprandial Glucose
30 minutes
|
245 mg/dL
|
278 mg/dL
|
|
AUC Postprandial Glucose
60 minutes
|
279 mg/dL
|
316 mg/dL
|
|
AUC Postprandial Glucose
120 minutes
|
310 mg/dL
|
274 mg/dL
|
|
AUC Postprandial Glucose
180 minutes
|
301 mg/dL
|
249 mg/dL
|
Adverse Events
Pre-prandial Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-prandial Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place