Trial Outcomes & Findings for Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia (NCT NCT01269047)
NCT ID: NCT01269047
Last Updated: 2018-04-12
Results Overview
We measured post-prandial blood sugars in both pramlintide and exenatide treated groups in acute and chronic setting, when compared to insulin monotherapy in subjects with Type 1 Diabetes Mellitus
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
6 months
Results posted on
2018-04-12
Participant Flow
37 participants were screened. Recruitment began at Baylor College of Medicine, TX in August of 2009 and the last study visit was in July of 2012 at Montefiore Medical Center, Bronx, NY
Participant milestones
| Measure |
Pramlintide + Insulin Group
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
|
Exenatide + Insulin Group
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
|
Insulin Monotherapy
This group will be on their regular insulin therapy.
Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
Baseline characteristics by cohort
| Measure |
Pramlintide + Insulin Group
n=12 Participants
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
|
Exenatide + Insulin Group
n=11 Participants
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
|
Insulin Monotherapy
n=10 Participants
This group will be on their regular insulin therapy.
Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
17.0 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
15.0 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
15.2 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
15.7 years
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American (AA)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed (White/AA)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsWe measured post-prandial blood sugars in both pramlintide and exenatide treated groups in acute and chronic setting, when compared to insulin monotherapy in subjects with Type 1 Diabetes Mellitus
Outcome measures
| Measure |
Acute Pramlintide + Insulin Group
n=12 Participants
The kids in Exenatide group will get a single dose of Pramlintide at the end of 4 months as part of the 4 hour MMTT.
The dose of pramlintide used for acute treatment is either 30 mcg or 60 mcg
|
Acute Exenatide + Insulin Group
n=11 Participants
The kids in Pramlintide group will get a single dose of Exenatide at the end of 4 months as part of the 4 hour MMTT.
The dose of pramlintide used for acute treatment is either 1.25 mcg or 2.5 mcg
|
Chronic Pramlintide + Insulin Group
n=11 Participants
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
|
Chronic Exenatide + Insulin Group
n=11 Participants
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
|
Insulin Monotherapy
n=10 Participants
These kids received insulin only treatment
|
|---|---|---|---|---|---|
|
Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus.
|
9.03 mmol/L
Standard Deviation 1.6
|
8.4 mmol/L
Standard Deviation 1.3
|
8.0 mmol/L
Standard Deviation 2.0
|
10.2 mmol/L
Standard Deviation 1.9
|
10.8 mmol/L
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Acute Pramlintide + Insulin Group
n=12 Participants
The kids in Exenatide group will get a single dose of Pramlintide at the end of 4 months as part of the 4 hour MMTT.
The dose of pramlintide used for acute treatment is either 30 mcg or 60 mcg
|
Acute Exenatide + Insulin Group
n=11 Participants
The kids in Pramlintide group will get a single dose of Exenatide at the end of 4 months as part of the 4 hour MMTT.
The dose of pramlintide used for acute treatment is either 1.25 mcg or 2.5 mcg
|
Chronic Pramlintide + Insulin Group
n=11 Participants
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
|
Chronic Exenatide + Insulin Group
n=11 Participants
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
|
Insulin Monotherapy
n=10 Participants
These kids received insulin only treatment
|
|---|---|---|---|---|---|
|
Difference in HbA1C Between the Treatment and the Control Groups
|
0.30 percentage of HbA1C values
Standard Deviation 0.8
|
0.60 percentage of HbA1C values
Standard Deviation 0.1
|
0.23 percentage of HbA1C values
Standard Deviation 0.6
|
0.40 percentage of HbA1C values
Standard Deviation 1.0
|
-0.40 percentage of HbA1C values
Standard Deviation 0.9
|
Adverse Events
Pramlintide + Insulin Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Exenatide + Insulin Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Insulin Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pramlintide + Insulin Group
n=13 participants at risk
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
|
Exenatide + Insulin Group
n=13 participants at risk
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
|
Insulin Monotherapy
n=11 participants at risk
This group will be on their regular insulin therapy.
Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
|
|---|---|---|---|
|
Endocrine disorders
Diabetic Ketoacidosis (DKA)
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place