Trial Outcomes & Findings for Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss? (NCT NCT02520518)

Results Overview

Via oral glucose tolerance test.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Baseline,12 weeks

Results posted on

2019-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Dapagliflozin: ad Libitum Dietary Intake Daily oral administration of dapagliflozin with ad libitum dietary intake. 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 Ad libitum dietary intake	Dapagliflozin: Weight Maintenance Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. 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 Weight maintenance	Placebo: ad Libitum Dietary Intake Daily oral administration of a placebo with ad-libitum dietary intake. 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 Ad libitum dietary intake	Placebo: Dietary Restriction Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. 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 Dietary restriction
Overall Study STARTED	3	1	3	2
Overall Study COMPLETED	3	1	1	1
Overall Study NOT COMPLETED	0	0	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapagliflozin: ad Libitum Dietary Intake n=3 Participants Daily oral administration of dapagliflozin with ad libitum dietary intake. 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 Ad libitum dietary intake	Dapagliflozin: Weight Maintenance n=1 Participants Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. 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 Weight maintenance	Placebo: ad Libitum Dietary Intake n=3 Participants Daily oral administration of a placebo with ad-libitum dietary intake. 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 Ad libitum dietary intake	Placebo: Dietary Restriction n=2 Participants Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. 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 Dietary restriction	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants	1 Participants n=1 Participants	3 Participants n=3 Participants	2 Participants n=2 Participants	9 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=9 Participants
Sex: Female, Male Female	3 Participants n=3 Participants	1 Participants n=1 Participants	3 Participants n=3 Participants	2 Participants n=2 Participants	9 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=9 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	1 participants n=1 Participants	3 participants n=3 Participants	2 participants n=2 Participants	9 participants n=9 Participants

PRIMARY outcome

Timeframe: Baseline,12 weeks

Population: Data were not collected.

Via oral glucose tolerance test.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Outcome measures
Measure	Dapagliflozin: ad Libitum Dietary Intake n=3 Participants Daily oral administration of dapagliflozin with ad libitum dietary intake. 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 Ad libitum dietary intake	Dapagliflozin: Weight Maintenance n=1 Participants Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. 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 Weight maintenance	Placebo: ad Libitum Dietary Intake n=2 Participants Daily oral administration of a placebo with ad-libitum dietary intake. 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 Ad libitum dietary intake	Placebo: Dietary Restriction n=3 Participants Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. 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 Dietary restriction
Change From Baseline in Blood Pressure at Week 12 Diastolic Blood Pressure Change	-1 mmHg Standard Deviation 0.2	-1 mmHg Standard Deviation 0	11 mmHg Standard Deviation 4	1 mmHg Standard Deviation 2
Change From Baseline in Blood Pressure at Week 12 Systolic Blood Pressure Change	2 mmHg Standard Deviation 1	5 mmHg Standard Deviation 0	11 mmHg Standard Deviation 8	0 mmHg Standard Deviation 3

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Perceptions of satiety will be determined using a visual analog scale called a Hunger Rating Scales. The minimum value is 1 (not at all full) and the maximum value is 100 (extremely full). One value between 1 and 100 is reported by the participant dependent on their perception. No sub scores are used. The perceived values are reported as the group average at baseline and 12 weeks. There is not a better or worse outcome, but rather a measure of perceived satiety. If Dapagliflozin were effective at increasing fullness, respondents would exhibit 12-week scores for the question in comparison to their baseline scores.

Outcome measures

Outcome measures
Measure	Dapagliflozin: ad Libitum Dietary Intake n=3 Participants Daily oral administration of dapagliflozin with ad libitum dietary intake. 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 Ad libitum dietary intake	Dapagliflozin: Weight Maintenance n=1 Participants Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. 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 Weight maintenance	Placebo: ad Libitum Dietary Intake n=1 Participants Daily oral administration of a placebo with ad-libitum dietary intake. 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 Ad libitum dietary intake	Placebo: Dietary Restriction n=3 Participants Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. 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 Dietary restriction
Change From Baseline in Perception of Satiety at Week 12 Baseline	50 score on a scale Standard Deviation 14	61 score on a scale Standard Deviation 0	35 score on a scale Standard Deviation 34	39 score on a scale Standard Deviation 14
Change From Baseline in Perception of Satiety at Week 12 12 weeks	56 score on a scale Standard Deviation 29	33 score on a scale Standard Deviation 0	38 score on a scale Standard Deviation 0	42 score on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Perceptions of Hunger will be determined using a visual analog scale called a Hunger Rating Scales. The minimum value is 1 (not at all hungry) and the maximum value is 100 (very hungry). One value between 1 and 100 is reported by the participant dependent on their perception. No sub scores are used. The perceived values are reported as the group average at baseline and 12 weeks. There is not a better or worse outcome, but rather a measure of perceived hunger. If Dapagliflozin were effective at decreasing hunger, respondents would exhibit 12-week scores for the question in comparison to their baseline scores.

Outcome measures

Outcome measures
Measure	Dapagliflozin: ad Libitum Dietary Intake n=3 Participants Daily oral administration of dapagliflozin with ad libitum dietary intake. 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 Ad libitum dietary intake	Dapagliflozin: Weight Maintenance n=1 Participants Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. 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 Weight maintenance	Placebo: ad Libitum Dietary Intake n=1 Participants Daily oral administration of a placebo with ad-libitum dietary intake. 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 Ad libitum dietary intake	Placebo: Dietary Restriction n=3 Participants Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. 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 Dietary restriction
Change From Baseline in Perception of Hunger at Week 12 Baseline	20 score on a scale Standard Deviation 22	24 score on a scale Standard Deviation 0	23.5 score on a scale Standard Deviation 1	32 score on a scale Standard Deviation 27
Change From Baseline in Perception of Hunger at Week 12 12 weeks	28 score on a scale Standard Deviation 38	77 score on a scale Standard Deviation 0	65 score on a scale Standard Deviation 0	31 score on a scale Standard Deviation 15

Adverse Events

Dapagliflozin: ad Libitum Dietary Intake

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dapagliflozin: Weight Maintenance

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo: ad Libitum Dietary Intake

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo: Dietary Restriction

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dapagliflozin: ad Libitum Dietary Intake n=3 participants at risk Daily oral administration of dapagliflozin with ad libitum dietary intake. 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 Ad libitum dietary intake	Dapagliflozin: Weight Maintenance n=1 participants at risk Daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance. 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 Weight maintenance	Placebo: ad Libitum Dietary Intake n=3 participants at risk Daily oral administration of a placebo with ad-libitum dietary intake. 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 Ad libitum dietary intake	Placebo: Dietary Restriction n=2 participants at risk Daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in Arm 1. 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 Dietary restriction
General disorders Stomach Pain	33.3% 1/3 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Loose Stool	33.3% 1/3 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Cold	33.3% 1/3 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Headache	66.7% 2/3 • Number of events 2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Vomiting	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	100.0% 1/1 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders increase in urination	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	100.0% 1/1 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Bronchitis	33.3% 1/3 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Fever and sore throat	33.3% 1/3 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	33.3% 1/3 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Stuffy Nose	33.3% 1/3 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/2 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
General disorders Anxiety	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	0.00% 0/3 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.	50.0% 1/2 • Number of events 1 • During the 12 week intervention period This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.

Additional Information

Manager of Research Operations

COLORADO STATE UNIVERSITY

Phone: 970-491-2242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place