Trial Outcomes & Findings for An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes (NCT NCT02962492)
NCT ID: NCT02962492
Last Updated: 2024-02-29
Results Overview
Beta-hydroxybutyrate (BHB) was measured in blood during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-02-29
Participant Flow
Participant milestones
| Measure |
Dapagliflozin Arm:
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Placebo Arm:
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
13
|
23
|
|
Overall Study
COMPLETED
|
15
|
15
|
11
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo Arm:
n=13 Participants
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Dapagliflozin Arm:
n=17 Participants
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
n=17 Participants
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
n=23 Participants
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 4.5 • n=13 Participants
|
50.5 years
STANDARD_DEVIATION 3.2 • n=17 Participants
|
46.5 years
STANDARD_DEVIATION 3.1 • n=17 Participants
|
44.1 years
STANDARD_DEVIATION 2.6 • n=23 Participants
|
46.6 years
STANDARD_DEVIATION 3.1 • n=70 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=13 Participants
|
7 Participants
n=17 Participants
|
7 Participants
n=17 Participants
|
11 Participants
n=23 Participants
|
31 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=13 Participants
|
10 Participants
n=17 Participants
|
10 Participants
n=17 Participants
|
12 Participants
n=23 Participants
|
39 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
30.8 kg/m²
STANDARD_DEVIATION 1.9 • n=13 Participants
|
28.1 kg/m²
STANDARD_DEVIATION 1.1 • n=17 Participants
|
31.4 kg/m²
STANDARD_DEVIATION 1.8 • n=17 Participants
|
30.7 kg/m²
STANDARD_DEVIATION 1.8 • n=23 Participants
|
30.3 kg/m²
STANDARD_DEVIATION 1.7 • n=70 Participants
|
|
Weight
|
85.3 Kg
STANDARD_DEVIATION 5.8 • n=13 Participants
|
82.6 Kg
STANDARD_DEVIATION 3.1 • n=17 Participants
|
91.0 Kg
STANDARD_DEVIATION 3.3 • n=17 Participants
|
91.0 Kg
STANDARD_DEVIATION 6.0 • n=23 Participants
|
87.9 Kg
STANDARD_DEVIATION 5.4 • n=70 Participants
|
|
HbA1c (%)
|
7.7 percentage of hemoglobin
STANDARD_DEVIATION 0.2 • n=13 Participants
|
7.6 percentage of hemoglobin
STANDARD_DEVIATION 0.2 • n=17 Participants
|
7.5 percentage of hemoglobin
STANDARD_DEVIATION 0.2 • n=17 Participants
|
7.9 percentage of hemoglobin
STANDARD_DEVIATION 0.2 • n=23 Participants
|
7.7 percentage of hemoglobin
STANDARD_DEVIATION 0.2 • n=70 Participants
|
|
daily Basal Insulin Dose/Kg
|
0.42 insulin units/kg
STANDARD_DEVIATION 0.08 • n=13 Participants
|
0.40 insulin units/kg
STANDARD_DEVIATION 0.06 • n=17 Participants
|
0.41 insulin units/kg
STANDARD_DEVIATION 0.05 • n=17 Participants
|
0.37 insulin units/kg
STANDARD_DEVIATION 0.03 • n=23 Participants
|
0.40 insulin units/kg
STANDARD_DEVIATION 0.06 • n=70 Participants
|
PRIMARY outcome
Timeframe: 12 weeksBeta-hydroxybutyrate (BHB) was measured in blood during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.
Outcome measures
| Measure |
Placebo Arm:
n=11 Participants
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Dapagliflozin Arm:
n=15 Participants
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
n=15 Participants
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
n=21 Participants
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
|---|---|---|---|---|
|
Change in Beta-hydroxybutyrate Levels in Blood
|
-0.23 mM
Standard Error 0.17
|
0.63 mM
Standard Error 0.22
|
0.24 mM
Standard Error 0.21
|
0.31 mM
Standard Error 0.19
|
SECONDARY outcome
Timeframe: 12 weeksHemoglobin A1c (HbA1c) was measured in basal conditions in all the groups at week 0 and week 12 of treatment. The change in HbA1c from baseline at 12 weeks is calculated as: HbA1c at week 12 - HbA1c at week 0.
Outcome measures
| Measure |
Placebo Arm:
n=15 Participants
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Dapagliflozin Arm:
n=15 Participants
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
n=11 Participants
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
n=21 Participants
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
|---|---|---|---|---|
|
Change in HbA1c Following Treatment
|
-0.3 Percent of Hemoglobin (%)
Standard Error 0.1
|
-0.4 Percent of Hemoglobin (%)
Standard Error 0.2
|
-0.1 Percent of Hemoglobin (%)
Standard Error 0.1
|
-0.9 Percent of Hemoglobin (%)
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 12 weeksBeta-hydroxybutyrate (BHB) was measured in urine during the acute stress conditions in all the groups after single dose intervention at baseline (0 Week) and at 12 weeks of treatment. The magnitude of change at each of these visits was calculated from each visit baseline (0 hr) and the difference between the change at 12 weeks was compared to the change at 0 week and reported as: Change at week 12 - change at week 0.
Outcome measures
| Measure |
Placebo Arm:
n=11 Participants
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Dapagliflozin Arm:
n=15 Participants
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
n=15 Participants
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
n=21 Participants
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
|---|---|---|---|---|
|
Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of Treatment
|
1.2 mM
Standard Error 0.5
|
0.4 mM
Standard Error 0.2
|
-0.7 mM
Standard Error 0.6
|
1.1 mM
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 12 weekschange in basal plasma glucagon after 12 weeks of dapagliflozin and Bydureon or combination of both treatments compared to baseline
Outcome measures
| Measure |
Placebo Arm:
n=11 Participants
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Dapagliflozin Arm:
n=15 Participants
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
n=15 Participants
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
n=21 Participants
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
|---|---|---|---|---|
|
Change in Plasma Glucagon
|
2 pg/ml
Standard Error 2
|
16 pg/ml
Standard Error 10
|
-15 pg/ml
Standard Error 8
|
-10 pg/ml
Standard Error 6
|
SECONDARY outcome
Timeframe: 12 weekschange in total (basal or long acting and short acting) insulin daily dose calculated as daily units/Kg body weight at 12 weeks from baseline (0 week). Long acting or basal insulin dose (in units of insulin) plus short acting (meal) insulin doses administered through the day and reported by patients in patients logs or from insulin pumps are added and divided by body weight in Kg. The reported total insulin dose/Kg represents the average of last 3-7 days before the visit.
Outcome measures
| Measure |
Placebo Arm:
n=11 Participants
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Dapagliflozin Arm:
n=15 Participants
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
n=15 Participants
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
n=21 Participants
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
|---|---|---|---|---|
|
Change in Total Insulin Dose
|
-0.01 Units/Kg
Standard Error 0.02
|
-0.02 Units/Kg
Standard Error 0.02
|
-0.05 Units/Kg
Standard Error 0.02
|
-0.04 Units/Kg
Standard Error 0.02
|
Adverse Events
Placebo Arm:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dapagliflozin Arm:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exenatide Extended Release Arm:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exenatide Extended Release & Dapagliflozin Arm:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Arm:
n=11 participants at risk
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Placebo: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Dapagliflozin Arm:
n=15 participants at risk
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release Arm:
n=15 participants at risk
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
Exenatide Extended Release & Dapagliflozin Arm:
n=21 participants at risk
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Exenatide/Exenatide extended release: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
Dapagliflozin: Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
|
|---|---|---|---|---|
|
Endocrine disorders
Severe Hypoglycemia
|
0.00%
0/11 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
0.00%
0/15 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
0.00%
0/15 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
0.00%
0/21 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
0.00%
0/11 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
0.00%
0/15 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
0.00%
0/15 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
0.00%
0/21 • 12 weeks
Patients were mainly monitored for 2 adverse events (also considered serious adverse events) throughout the study (12 weeks) related to: 1. severe hypoglycemia (blood sugar \<35mg/dl and requiring assistance) 2. diagnosis of diabetic ketoacidosis
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place