Trial Outcomes & Findings for Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss? (NCT NCT03180489)

Last Updated: 2020-02-11

Results Overview

Insulin sensitivity was estimated by measuring circulating insulin concentrations after a 12 hour fast and after ingesting 75 g of glucose. Insulin was measured 0, 30, 60, 90 and 120 minutes after glucose ingestion. Time point 0 minutes is reported below.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Dapagliflozin With Dietary Counseling Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 With Dietary Counseling Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.
Overall Study STARTED	33	29
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	8	4

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 With Dietary Counseling n=25 Participants Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 With Dietary Counseling n=25 Participants Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	25 Participants n=25 Participants	50 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Sex: Female, Male Female	20 Participants n=25 Participants	18 Participants n=25 Participants	38 Participants n=50 Participants
Sex: Female, Male Male	5 Participants n=25 Participants	7 Participants n=25 Participants	12 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Height	1.69 meters STANDARD_DEVIATION 0.08 • n=25 Participants	1.67 meters STANDARD_DEVIATION 0.09 • n=25 Participants	1.68 meters STANDARD_DEVIATION 0.08 • n=50 Participants
Body Mass	96.5 kg STANDARD_DEVIATION 15.6 • n=25 Participants	93.8 kg STANDARD_DEVIATION 20.4 • n=25 Participants	95.13 kg STANDARD_DEVIATION 18.0 • n=50 Participants
Body Mass Index	33.5 kg/m2 STANDARD_DEVIATION 3.9 • n=25 Participants	33.2 kg/m2 STANDARD_DEVIATION 5.6 • n=25 Participants	33.4 kg/m2 STANDARD_DEVIATION 4.7 • n=50 Participants
Systolic Blood Pressure	116 mmHg STANDARD_DEVIATION 8 • n=25 Participants	112 mmHg STANDARD_DEVIATION 10 • n=25 Participants	114 mmHg STANDARD_DEVIATION 9 • n=50 Participants
Diastolic Blood Pressure	69 mmHg STANDARD_DEVIATION 5 • n=25 Participants	69 mmHg STANDARD_DEVIATION 8 • n=25 Participants	69 mmHg STANDARD_DEVIATION 7 • n=50 Participants
Peak Oxygen Uptake	22.2 ml/kg/min STANDARD_DEVIATION 5.0 • n=25 Participants	24.8 ml/kg/min STANDARD_DEVIATION 5.6 • n=25 Participants	23.5 ml/kg/min STANDARD_DEVIATION 5.4 • n=50 Participants
Fasting Glucose	74.7 mg/dL STANDARD_DEVIATION 6.9 • n=25 Participants	76.1 mg/dL STANDARD_DEVIATION 7.7 • n=25 Participants	75.4 mg/dL STANDARD_DEVIATION 7.3 • n=50 Participants
Fasting Insulin	6.9 mU/L STANDARD_DEVIATION 0.8 • n=25 Participants	11.1 mU/L STANDARD_DEVIATION 3.5 • n=25 Participants	9.0 mU/L STANDARD_DEVIATION 12.7 • n=50 Participants
Dietary Intake	1819 kcal/day STANDARD_DEVIATION 491 • n=25 Participants	2187 kcal/day STANDARD_DEVIATION 541 • n=25 Participants	2003 kcal/day STANDARD_DEVIATION 538 • n=50 Participants
Carbohydrate	197 g/day STANDARD_DEVIATION 59 • n=25 Participants	246 g/day STANDARD_DEVIATION 73 • n=25 Participants	222 g/day STANDARD_DEVIATION 69 • n=50 Participants
Fat	77 g/day STANDARD_DEVIATION 26 • n=25 Participants	91 g/day STANDARD_DEVIATION 28 • n=25 Participants	84 g/day STANDARD_DEVIATION 28 • n=50 Participants
Protein	80 g/day STANDARD_DEVIATION 25 • n=25 Participants	85 g/day STANDARD_DEVIATION 24 • n=25 Participants	83 g/day STANDARD_DEVIATION 24 • n=50 Participants
eGFR	154 mL/min/173m2 STANDARD_DEVIATION 52 • n=25 Participants	152 mL/min/173m2 STANDARD_DEVIATION 54 • n=25 Participants	153 mL/min/173m2 STANDARD_DEVIATION 52 • n=50 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Outcome measures

Outcome measures
Measure	Dapagliflozin With Dietary Counseling n=25 Participants Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 With Dietary Counseling n=25 Participants Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.
Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test Baseline	6.9 mU/L Standard Deviation 0.8	11.1 mU/L Standard Deviation 3.5
Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test 12 Weeks	5.5 mU/L Standard Deviation 0.7	6.5 mU/L Standard Deviation 1.0

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Blood pressure was measured with an automatic machine at baseline. Numbers are reported as systolic/diastolic

Outcome measures

Outcome measures
Measure	Dapagliflozin With Dietary Counseling n=25 Participants Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 With Dietary Counseling n=25 Participants Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.
Change From Baseline in Blood Pressure at Week 12 Systolic	116 mmHg Standard Deviation 10	112 mmHg Standard Deviation 8
Change From Baseline in Blood Pressure at Week 12 Diastolic	69 mmHg Standard Deviation 8	69 mmHg Standard Deviation 5

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Participants answered a satiety questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses how full do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How full do you feel right now)? Answer 0: Not full at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely full. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented a decreased desire to eat.

Outcome measures

Outcome measures
Measure	Dapagliflozin With Dietary Counseling n=25 Participants Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 With Dietary Counseling n=25 Participants Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.
Change From Baseline in Perception of Satiety at Week 12 Baseline	27 score on a scale Standard Deviation 16	21 score on a scale Standard Deviation 12
Change From Baseline in Perception of Satiety at Week 12 12 Weeks	31 score on a scale Standard Deviation 18	28 score on a scale Standard Deviation 16

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Participants answered a hunger questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses to how hungry do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How hungry do you feel right now? Answer 0: Not hungry at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely hungry. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented an increased desire to eat.

Outcome measures

Outcome measures
Measure	Dapagliflozin With Dietary Counseling n=25 Participants Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 With Dietary Counseling n=25 Participants Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.
Change From Baseline in Perception of Hunger at Week 12 Baseline	42 score on a scale Standard Deviation 25	53 score on a scale Standard Deviation 18
Change From Baseline in Perception of Hunger at Week 12 12 Weeks	39 score on a scale Standard Deviation 20	53 score on a scale Standard Deviation 21

Adverse Events

Dapagliflozin With Dietary Counseling

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo With Dietary Counseling

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dapagliflozin With Dietary Counseling n=33 participants at risk Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Dapagliflozin Tablet: Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet 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 With Dietary Counseling n=29 participants at risk Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Placebo Tablet: Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet 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.
Immune system disorders Allergies	6.1% 2/33 • Number of events 2 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	10.3% 3/29 • Number of events 3 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
Infections and infestations Cold Symptoms	45.5% 15/33 • Number of events 22 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	44.8% 13/29 • Number of events 22 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
Gastrointestinal disorders Stomach Pain and Diarrhea	18.2% 6/33 • Number of events 10 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	17.2% 5/29 • Number of events 6 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Headache and Dizziness	30.3% 10/33 • Number of events 19 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	31.0% 9/29 • Number of events 15 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
Musculoskeletal and connective tissue disorders Muscle Joint Soreness and Pain	27.3% 9/33 • Number of events 13 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	20.7% 6/29 • Number of events 7 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Urinary Disorders, Yeast Infections and PMS	18.2% 6/33 • Number of events 7 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	24.1% 7/29 • Number of events 15 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Tooth Pain	3.0% 1/33 • Number of events 1 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	0.00% 0/29 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Cold Sores	3.0% 1/33 • Number of events 1 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	0.00% 0/29 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Inflammation	3.0% 1/33 • Number of events 1 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	0.00% 0/29 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
Skin and subcutaneous tissue disorders Acne	0.00% 0/33 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	3.4% 1/29 • Number of events 1 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Vitamin D Deficiency	0.00% 0/33 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	3.4% 1/29 • Number of events 1 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Thirst	0.00% 0/33 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	3.4% 1/29 • Number of events 1 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.
General disorders Anxiety Attack	0.00% 0/33 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.	3.4% 1/29 • Number of events 2 • Adverse event data was collected throughout the 12 week intervention period. Subjects were withdrawn are included in the Adverse Event data but are not included in the analysis of the Baseline Characteristics and the Outcome Measures data.

Additional Information

Christopher Bell

Colorado State University

Phone: 9704917522

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place