Trial Outcomes & Findings for Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (NCT NCT02981966)
NCT ID: NCT02981966
Last Updated: 2024-03-04
Results Overview
Endogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
3 weeks
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
T2DM Individuals on Dapagliflozin
Individuals with type 2 diabetes mellitus - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
T2DM Individuals on Placebo
Individuals with type 2 diabetes mellitus on placebo
Placebo: Placebo for dapagliflozin
|
Normal Glucose Tolerance (NGT) on Dapagliflozin
Individuals with normal glucose tolerance - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
Normal Glucose Tolerance (NGT) Placebo
Individuals with normal glucose tolerance - on placebo
Placebo: Placebo for dapagliflozin
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
7
|
8
|
4
|
|
Overall Study
COMPLETED
|
13
|
7
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects
Baseline characteristics by cohort
| Measure |
T2DM Individuals on Dapagliflozin
n=13 Participants
Individuals with type 2 diabetes mellitus - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
T2DM Individuals on Placebo
n=7 Participants
Individuals with type 2 diabetes mellitus on placebo
Placebo: Placebo for dapagliflozin
|
Normal Glucose Tolerance (NGT) on Dapagliflozin
n=8 Participants
Individuals with normal glucose tolerance - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
Normal Glucose Tolerance (NGT) Placebo
n=4 Participants
Individuals with normal glucose tolerance - on placebo
Placebo: Placebo for dapagliflozin
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 3 • n=5 Participants
|
58 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
44 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
47 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
51.5 years
STANDARD_DEVIATION 2.95 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
4 participants
n=4 Participants
|
32 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 weeksEndogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.
Outcome measures
| Measure |
T2DM Individuals on Dapagliflozin
n=13 Participants
Individuals with type 2 diabetes mellitus - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
T2DM Individuals on Placebo
n=7 Participants
Individuals with type 2 diabetes mellitus on placebo
Placebo: Placebo for dapagliflozin
|
Normal Glucose Tolerance (NGT) on Dapagliflozin
n=8 Participants
Individuals with normal glucose tolerance - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
Normal Glucose Tolerance (NGT) Placebo
n=4 Participants
Individuals with normal glucose tolerance - on placebo
Placebo: Placebo for dapagliflozin
|
|---|---|---|---|---|
|
Endogenous Glucose Production Measurement
|
155 mg/dl
Standard Deviation 6.4
|
121 mg/dl
Standard Deviation 6.2
|
104 mg/dl
Standard Deviation 4.2
|
98 mg/dl
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline to 3 weeksRenal Glucose Production in T2DM and NGT subjects before and after dapagliflozin/placebo administration from baseline to 240 minutes.
Outcome measures
| Measure |
T2DM Individuals on Dapagliflozin
n=13 Participants
Individuals with type 2 diabetes mellitus - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
T2DM Individuals on Placebo
n=7 Participants
Individuals with type 2 diabetes mellitus on placebo
Placebo: Placebo for dapagliflozin
|
Normal Glucose Tolerance (NGT) on Dapagliflozin
n=8 Participants
Individuals with normal glucose tolerance - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
Normal Glucose Tolerance (NGT) Placebo
n=4 Participants
Individuals with normal glucose tolerance - on placebo
Placebo: Placebo for dapagliflozin
|
|---|---|---|---|---|
|
Renal Glucose Production Measurement of Change
Baseline
|
0.09 mg/kg.min
Standard Deviation 0.04
|
0.01 mg/kg.min
Standard Deviation 0.03
|
0.03 mg/kg.min
Standard Deviation 0.09
|
0.03 mg/kg.min
Standard Deviation 0.09
|
|
Renal Glucose Production Measurement of Change
3 weeks
|
0.17 mg/kg.min
Standard Deviation 0.05
|
0.03 mg/kg.min
Standard Deviation 0.05
|
0.09 mg/kg.min
Standard Deviation 0.1
|
0.14 mg/kg.min
Standard Deviation 0.12
|
Adverse Events
T2DM Individuals on Dapagliflozin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
T2DM Individuals on Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Glucose Tolerance (NGT) on Dapagliflozin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Glucose Tolerance (NGT) 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 |
T2DM Individuals on Dapagliflozin
n=13 participants at risk
Individuals with type 2 diabetes mellitus - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
T2DM Individuals on Placebo
n=7 participants at risk
Individuals with type 2 diabetes mellitus on placebo
Placebo: Placebo for dapagliflozin
|
Normal Glucose Tolerance (NGT) on Dapagliflozin
n=8 participants at risk
Individuals with normal glucose tolerance - dapagliflozin
Dapagliflozin: dapagliflozin, 10mg tablet
|
Normal Glucose Tolerance (NGT) Placebo
n=4 participants at risk
Individuals with normal glucose tolerance - on placebo
Placebo: Placebo for dapagliflozin
|
|---|---|---|---|---|
|
General disorders
Transcient Syncope
|
0.00%
0/13 • 4 years
|
14.3%
1/7 • Number of events 1 • 4 years
|
12.5%
1/8 • Number of events 1 • 4 years
|
0.00%
0/4 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place