Trial Outcomes & Findings for SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2 (NCT NCT02592421)
NCT ID: NCT02592421
Last Updated: 2020-09-17
Results Overview
Change from baseline to the last hour of the study (240-300 minutes) in plasma glucose concentration
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
Baseline to 240-300 minutes
Results posted on
2020-09-17
Participant Flow
Participant milestones
| Measure |
Dapagliflozin
Subjects will receive dapagliflozin 10mg
Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
|
Placebo
Subjects will receive placebo
Placebo: Placebo Comparator
|
|---|---|---|
|
Study 1
STARTED
|
20
|
10
|
|
Study 1
COMPLETED
|
20
|
10
|
|
Study 1
NOT COMPLETED
|
0
|
0
|
|
Study 2: Glucose Clamp Conditions
STARTED
|
20
|
10
|
|
Study 2: Glucose Clamp Conditions
COMPLETED
|
20
|
10
|
|
Study 2: Glucose Clamp Conditions
NOT COMPLETED
|
0
|
0
|
|
Study 3: Pancreatic Clamp Conditions
STARTED
|
20
|
10
|
|
Study 3: Pancreatic Clamp Conditions
COMPLETED
|
20
|
10
|
|
Study 3: Pancreatic Clamp Conditions
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=20 Participants
Subjects will receive dapagliflozin 10mg
Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
|
Placebo
n=10 Participants
Subjects will receive placebo
Placebo: Placebo Comparator
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 Years
STANDARD_DEVIATION 2 • n=5 Participants
|
53 Years
STANDARD_DEVIATION 2 • n=7 Participants
|
53.5 Years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
10 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.6 kg/m^2
STANDARD_DEVIATION 0.7 • n=5 Participants
|
31.4 kg/m^2
STANDARD_DEVIATION 1.3 • n=7 Participants
|
32 kg/m^2
STANDARD_DEVIATION 2.85 • n=5 Participants
|
|
Diabetes Duration
|
6.9 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.9 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
6.4 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Free Plasma Glucose (FPG)
|
148 mg/dL
STANDARD_DEVIATION 8 • n=5 Participants
|
127 mg/dL
STANDARD_DEVIATION 8 • n=7 Participants
|
137 mg/dL
STANDARD_DEVIATION 8 • n=5 Participants
|
|
HBA1c (3 month blood glucose level measure)
|
7.5 Percentage of glycated hemoglobin
STANDARD_DEVIATION 0.2 • n=5 Participants
|
7.5 Percentage of glycated hemoglobin
STANDARD_DEVIATION 0.1 • n=7 Participants
|
7.5 Percentage of glycated hemoglobin
STANDARD_DEVIATION 0.15 • n=5 Participants
|
|
Glomerular Filtration Rate (eGFR)
|
97 ml/min
STANDARD_DEVIATION 3 • n=5 Participants
|
97 ml/min
STANDARD_DEVIATION 3 • n=7 Participants
|
97 ml/min
STANDARD_DEVIATION 3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 240-300 minutesChange from baseline to the last hour of the study (240-300 minutes) in plasma glucose concentration
Outcome measures
| Measure |
Dapagliflozin
n=20 Participants
Subjects will receive dapagliflozin 10mg
Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
|
Placebo
n=10 Participants
Subjects will receive placebo
Placebo: Placebo Comparator
|
|---|---|---|
|
Change in Plasma Glucose Concentration
Study 1
|
-29.7 mg/dl
Standard Deviation 3
|
-17.2 mg/dl
Standard Deviation 2.9
|
|
Change in Plasma Glucose Concentration
Study 2 with glucose clamp
|
3.1 mg/dl
Standard Deviation 0.9
|
0.9 mg/dl
Standard Deviation 1.1
|
|
Change in Plasma Glucose Concentration
Study 3 with pancreatic clamp
|
-30.3 mg/dl
Standard Deviation 3.5
|
-2.3 mg/dl
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: Baseline to 240-300 minutesThe change in endogenous glucose production is measured from baseline until the last hour of the study
Outcome measures
| Measure |
Dapagliflozin
n=20 Participants
Subjects will receive dapagliflozin 10mg
Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
|
Placebo
n=10 Participants
Subjects will receive placebo
Placebo: Placebo Comparator
|
|---|---|---|
|
Change in Endogenous Glucose Production (EGP)
Study 1
|
0.1 mg/kg.min
Standard Deviation 0.1
|
-0.56 mg/kg.min
Standard Deviation 0.1
|
|
Change in Endogenous Glucose Production (EGP)
Study 2 with glucose clamp
|
-0.57 mg/kg.min
Standard Deviation 0.12
|
-1.28 mg/kg.min
Standard Deviation 0.17
|
|
Change in Endogenous Glucose Production (EGP)
Study 3 with pancreatic clamp
|
-0.23 mg/kg.min
Standard Deviation 0.09
|
-0.48 mg/kg.min
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Baseline to 240-300 minutesMeasurement of change in plasma insulin concentration during measurement of of EGP from baseline to last hour of the study
Outcome measures
| Measure |
Dapagliflozin
n=20 Participants
Subjects will receive dapagliflozin 10mg
Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
|
Placebo
n=10 Participants
Subjects will receive placebo
Placebo: Placebo Comparator
|
|---|---|---|
|
Change in Plasma Insulin During Measurement of EGP
Study 1
|
5 microUnits/mL
Standard Deviation 1
|
3 microUnits/mL
Standard Deviation 1
|
|
Change in Plasma Insulin During Measurement of EGP
Study 2 with glucose clamp
|
0 microUnits/mL
Standard Deviation 1
|
0 microUnits/mL
Standard Deviation 1
|
|
Change in Plasma Insulin During Measurement of EGP
Study 3 with pancreatic clamp
|
2 microUnits/mL
Standard Deviation 1
|
0 microUnits/mL
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Baseline to 240-300 minutesMeasurement of change in glucagon during EGP measurement from baseline to the last hour of the study
Outcome measures
| Measure |
Dapagliflozin
n=20 Participants
Subjects will receive dapagliflozin 10mg
Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
|
Placebo
n=10 Participants
Subjects will receive placebo
Placebo: Placebo Comparator
|
|---|---|---|
|
Change in Glucagon During EGP Measurement
Study 1
|
5 ng/ml
Standard Deviation 2
|
-1 ng/ml
Standard Deviation 2
|
|
Change in Glucagon During EGP Measurement
Study 2 with glucose clamp
|
-6 ng/ml
Standard Deviation 2
|
-7 ng/ml
Standard Deviation 3
|
|
Change in Glucagon During EGP Measurement
Study 3 with pancreatic clamp
|
-1 ng/ml
Standard Deviation 1
|
-2 ng/ml
Standard Deviation 2
|
Adverse Events
Dapagliflozin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
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 |
Dapagliflozin
n=20 participants at risk
Subjects will receive dapagliflozin 10mg
Dapagliflozin: SGLT2 inhibitor (dapagliflozin)
|
Placebo
n=10 participants at risk
Subjects will receive placebo
Placebo: Placebo Comparator
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Number of events 4 • Adverse events were collected during the study procedure, from baseline to 300 minutes
|
0.00%
0/10 • Adverse events were collected during the study procedure, from baseline to 300 minutes
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place