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Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?

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ClinicalTrials.gov Identifier: NCT02520518
Recruitment Status : Terminated (Designed a new modified/simplified protocol see NCT 03180489)
First Posted : August 13, 2015
Results First Posted : December 11, 2018
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Christopher Bell, Colorado State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Weight Loss
Interventions Drug: Dapagliflozin
Drug: Placebo
Behavioral: Weight maintenance
Behavioral: Ad libitum dietary intake
Behavioral: Dietary restriction
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 3 1 3 2
Completed 3 1 1 1
Not Completed 0 0 2 1
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 3 1 3 2 9
Hide Baseline Analysis Population Description
Some of the participants with baseline measures collected either declined participation or were enrolled in the amended protocol NCT03180489.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 3 participants 2 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
1
 100.0%
3
 100.0%
2
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 3 participants 2 participants 9 participants
Female
3
 100.0%
1
 100.0%
3
 100.0%
2
 100.0%
9
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 1 participants 3 participants 2 participants 9 participants
3 1 3 2 9
1.Primary Outcome
Title Change From Baseline in Insulin Sensitivity at Week 12
Hide Description Via oral glucose tolerance test.
Time Frame Baseline,12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change From Baseline in Blood Pressure at Week 12
Hide Description [Not Specified]
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: Dietary Restriction Placebo: ad Libitum Dietary Intake
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 3 1 2 3
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Blood Pressure Change 2  (1) 5  (0) 11  (8) 0  (3)
Diastolic Blood Pressure Change -1  (0.2) -1  (0) 11  (4) 1  (2)
3.Primary Outcome
Title Change From Baseline in Perception of Satiety at Week 12
Hide Description 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.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: Dietary Restriction Placebo: ad Libitum Dietary Intake
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 3 1 1 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 50  (14) 61  (0) 35  (34) 39  (14)
12 weeks 56  (29) 33  (0) 38  (0) 42  (10)
4.Primary Outcome
Title Change From Baseline in Perception of Hunger at Week 12
Hide Description 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.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: Dietary Restriction Placebo: ad Libitum Dietary Intake
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 3 1 1 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 20  (22) 24  (0) 23.5  (1) 32  (27)
12 weeks 28  (38) 77  (0) 65  (0) 31  (15)
5.Primary Outcome
Title Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data collection was not performed
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data collection was not performed
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Change From Baseline in Hunger Hormone Ghrelin at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Primary Outcome
Title Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Primary Outcome
Title Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Primary Outcome
Title Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Primary Outcome
Title Change From Baseline in Satiety Hormone Leptin at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Primary Outcome
Title Change From Baseline in Satiety Hormone Insulin at Week 12
Hide Description Will be analyzed using a commercially available biochemical assay.
Time Frame Baseline, 12 weeks
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Hide Analysis Population Description
Data were not collected.
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
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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

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

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

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 Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame During the 12 week intervention period
Adverse Event Reporting Description This study was performed on a healthy population and mortality is not an outcome. All cause mortality was monitored.
 
Arm/Group Title Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dapagliflozin: ad Libitum Dietary Intake Dapagliflozin: Weight Maintenance Placebo: ad Libitum Dietary Intake Placebo: Dietary Restriction
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      1/1 (100.00%)      1/3 (33.33%)      1/2 (50.00%)    
General disorders         
Stomach Pain *  1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0
Loose Stool *  1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0
Cold *  1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0
Headache *  2/3 (66.67%)  2 0/1 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0
Vomiting *  0/3 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0
increase in urination *  0/3 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/2 (0.00%)  0
Bronchitis *  1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0
Fever and sore throat *  1/3 (33.33%)  1 0/1 (0.00%)  0 1/3 (33.33%)  1 0/2 (0.00%)  0
Stuffy Nose *  1/3 (33.33%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/2 (0.00%)  0
Anxiety *  0/3 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Manager of Research Operations
Organization: COLORADO STATE UNIVERSITY
Phone: 970-491-2242
EMail: Laurie.Biela@colostate.edu
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Responsible Party: Christopher Bell, Colorado State University
ClinicalTrials.gov Identifier: NCT02520518     History of Changes
Other Study ID Numbers: 14-5531H
First Submitted: July 27, 2015
First Posted: August 13, 2015
Results First Submitted: August 14, 2018
Results First Posted: December 11, 2018
Last Update Posted: January 3, 2019