Trial Outcomes & Findings for Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training? (NCT NCT02371187)
NCT ID: NCT02371187
Last Updated: 2019-04-10
Results Overview
Indirect calorimetry
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Baseline,12 weeks
Results posted on
2019-04-10
Participant Flow
Participant milestones
| Measure |
Dapagliflozin
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=15 Participants
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
n=15 Participants
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Total
n=30 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
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 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
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Height
|
1.67 meters
STANDARD_DEVIATION 0.08 • n=99 Participants
|
1.71 meters
STANDARD_DEVIATION 0.10 • n=107 Participants
|
1.69 meters
STANDARD_DEVIATION 8.92 • n=206 Participants
|
|
Body Mass
|
87.8 Kilograms
STANDARD_DEVIATION 17.3 • n=99 Participants
|
91.8 Kilograms
STANDARD_DEVIATION 16.9 • n=107 Participants
|
89.80 Kilograms
STANDARD_DEVIATION 16.9 • n=206 Participants
|
|
Body Mass Index
|
31.3 kilograms per meters squared
STANDARD_DEVIATION 5.4 • n=99 Participants
|
31.2 kilograms per meters squared
STANDARD_DEVIATION 4.3 • n=107 Participants
|
31.3 kilograms per meters squared
STANDARD_DEVIATION 4.77 • n=206 Participants
|
|
Systolic Blood Pressure
|
130 millimeter of mercury
STANDARD_DEVIATION 14 • n=99 Participants
|
129 millimeter of mercury
STANDARD_DEVIATION 13 • n=107 Participants
|
129.5 millimeter of mercury
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Diastolic Blood Pressure
|
83 millimeters of mercury
STANDARD_DEVIATION 10 • n=99 Participants
|
82 millimeters of mercury
STANDARD_DEVIATION 11 • n=107 Participants
|
83 millimeters of mercury
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Peak Oxygen Uptake
|
26.9 milliliter per kilogram per minute
STANDARD_DEVIATION 5.3 • n=99 Participants
|
30.1 milliliter per kilogram per minute
STANDARD_DEVIATION 6.1 • n=107 Participants
|
27.49 milliliter per kilogram per minute
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
Fasting Glucose
|
78.8 milligrams per deciliter
STANDARD_DEVIATION 7.3 • n=99 Participants
|
75.8 milligrams per deciliter
STANDARD_DEVIATION 5.1 • n=107 Participants
|
77.3 milligrams per deciliter
STANDARD_DEVIATION 5.9 • n=206 Participants
|
|
Fasting Insulin
|
7.6 MilliUnits per Liter
STANDARD_DEVIATION 4.0 • n=99 Participants
|
8.9 MilliUnits per Liter
STANDARD_DEVIATION 6.7 • n=107 Participants
|
8.3 MilliUnits per Liter
STANDARD_DEVIATION 5.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline,12 weeksIndirect calorimetry
Outcome measures
| Measure |
Dapagliflozin
n=15 Participants
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
n=15 Participants
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
|---|---|---|
|
Change From Baseline of Maximal Oxygen Uptake at Week 12
Pre-Exercise Training
|
26.9 Milliliters/Kilogram/Minute
Standard Deviation 5.3
|
30.1 Milliliters/Kilogram/Minute
Standard Deviation 6.1
|
|
Change From Baseline of Maximal Oxygen Uptake at Week 12
Post-Exercise Training
|
30.6 Milliliters/Kilogram/Minute
Standard Deviation 6.1
|
32.4 Milliliters/Kilogram/Minute
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksThe respiratory exchange ratio (RER) is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used during standardized exercise.
Outcome measures
| Measure |
Dapagliflozin
n=15 Participants
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
n=15 Participants
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
|---|---|---|
|
Change From Baseline of Respiratory Exchange Ratio at Week 12
Pre-Exercise Training
|
1.91 Respiratory Exchange Ratio
Standard Deviation 0.05
|
1.16 Respiratory Exchange Ratio
Standard Deviation 0.12
|
|
Change From Baseline of Respiratory Exchange Ratio at Week 12
Post-Exercise Training
|
1.19 Respiratory Exchange Ratio
Standard Deviation 0.05
|
1.13 Respiratory Exchange Ratio
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksMaximal citrate synthase activity in skeletal muscle sample
Outcome measures
| Measure |
Dapagliflozin
n=15 Participants
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
n=15 Participants
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
|---|---|---|
|
Change From Baseline of Maximal Aerobic Enzyme Activities in Skeletal Muscle at Week 12
Pre-Exercise Training
|
6.3 micromol/min/miligram protein
Standard Deviation 3.7
|
5.8 micromol/min/miligram protein
Standard Deviation 3.6
|
|
Change From Baseline of Maximal Aerobic Enzyme Activities in Skeletal Muscle at Week 12
Post Exercise Training
|
8.1 micromol/min/miligram protein
Standard Deviation 4.5
|
8.0 micromol/min/miligram protein
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksInsulin Sensitivity was estimated by measuring circulating glucose and insulin concentrations after a 12-hour fast and after ingestion of 75 g of glucose. Glucose was measured 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes after glucose ingestion. Insulin was measured 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion. Insulin sensitivity was estimated using the Matsuda Index, represented by the formula: Matsuda index = 10,000/SQRT \[fasting glucose\*fasting insulin\* (mean glucose from time 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes) \* (mean insulin from time 15, 30, 45, 60, 90 and 120 minutes)\], with higher numbers indicating better insulin sensitivity.
Outcome measures
| Measure |
Dapagliflozin
n=15 Participants
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
n=15 Participants
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
|---|---|---|
|
Change From Baseline of Insulin Sensitivity at Week 12
Pre-Training
|
8.7 MATSUDA Index
Standard Deviation 4.8
|
8.3 MATSUDA Index
Standard Deviation 4.9
|
|
Change From Baseline of Insulin Sensitivity at Week 12
Post-Training
|
9.5 MATSUDA Index
Standard Deviation 4.8
|
12.9 MATSUDA Index
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksVia dual energy X-ray absorptiometry
Outcome measures
| Measure |
Dapagliflozin
n=15 Participants
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
n=15 Participants
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
|---|---|---|
|
Change From Baseline of Fat Free Mass at Week 12
Pre-Exercise Training
|
52 Kilograms
Standard Deviation 9.9
|
57.8 Kilograms
Standard Deviation 12.2
|
|
Change From Baseline of Fat Free Mass at Week 12
Post-Exercise Training
|
52.2 Kilograms
Standard Deviation 9.9
|
58.3 Kilograms
Standard Deviation 12.1
|
Adverse Events
Dapagliflozin
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapagliflozin
n=18 participants at risk
The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study.
Dapagliflozin: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
Placebo
n=19 participants at risk
Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
Placebo: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
|
|---|---|---|
|
General disorders
Headaches and Dizziness
|
22.2%
4/18 • Number of events 5 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
36.8%
7/19 • Number of events 7 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
|
General disorders
Cold Symptoms
|
38.9%
7/18 • Number of events 8 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
52.6%
10/19 • Number of events 15 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
|
General disorders
Chest Congestion
|
5.6%
1/18 • Number of events 1 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
10.5%
2/19 • Number of events 2 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
|
General disorders
General Stomach Pain and Diarrhea
|
38.9%
7/18 • Number of events 7 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
26.3%
5/19 • Number of events 9 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
|
General disorders
Muscle soreness and joint pain
|
44.4%
8/18 • Number of events 10 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
36.8%
7/19 • Number of events 9 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
|
General disorders
Urinary Disorders and Yeast Infections
|
16.7%
3/18 • Number of events 3 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
15.8%
3/19 • Number of events 4 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
5.3%
1/19 • Number of events 1 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
|
General disorders
Rash or skin irritation
|
5.6%
1/18 • Number of events 1 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
5.3%
1/19 • Number of events 1 • Throughout the 12 week intervention period
Subjects withdrawn are not included in the analysis of Baseline Characteristics and Outcome Measures, but are included for Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place