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Designed a new modified/simplified protocol see NCT 03180489
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Th mechanism of action of dapagliflozin is via sodium-glucose co-transporter 2 (SGLT2) inhibition. Sodium-glucose co-transporter 2 inhibition is associated with moderate weight (fat) loss, in addition to other health benefits, including decreased blood pressure, decreased inflammation, and decreased oxidative stress. It is unclear as to whether these health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss.
This is a randomized, prospective, placebo-controlled, double-blind, repeated measures study. 92 overweight/obese adults (body mas index > 27.5 kg/m^2) will be recruited for participation and randomly assigned to one of four 12 week treatments: 1) daily oral administration of dapagliflozin with ad-libitum dietary intake; 2) daily oral administration of dapagliflozin with supplemented dietary intake to achieve weight maintenance; 3) daily oral administration of a placebo plus dietary restriction such that weight loss is matched to participants in treatment 1; or, 4) daily oral administration of a placebo with ad-libitum dietary intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin: ad libitum dietary intake | Experimental | 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: weight maintenance | Experimental | 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. |
|
| Placebo: ad libitum dietary intake | Placebo Comparator | 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: dietary restriction | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Insulin Sensitivity at Week 12 | Via oral glucose tolerance test. | Baseline,12 weeks |
| Change From Baseline in Blood Pressure at Week 12 | Baseline, 12 weeks | |
| Change From Baseline in Perception of Satiety at Week 12 | 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. | Baseline, 12 weeks |
| Change From Baseline in Perception of Hunger at Week 12 | 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. | Baseline, 12 weeks |
| Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Evidence of clinically significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, haematological, neurological, psychiatric, or other disease that may interfere with the objectives of the study or the safety of the subject, as judged by the investigator in agreement with the sponsor or medical monitor, have been hospitalized in the past 2 years as a result of these conditions, or are receiving pharmacological treatment for these conditions
Use of prescription drugs (see exceptions listed below) or herbal preparations in the 4 weeks before study commencement.
Permitted Prescription Drugs
Is currently enrolled in another clinical study for another investigational drug or has taken any other investigational drug within 30 days before the screening visit.
Habitual and/or recent use (within 2 years) of tobacco
Being considered unsuitable for participation in this trial for any reason, as judged by the investigator or medical monitor.
History of serious hypersensitivity reaction to dapagliflozin
Severe renal impairment, end-stage renal disease, or dialysis
Pregnant or breastfeeding patients
Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal and/or alanine aminotransferase (ALT) >3x upper limit of normal
Total bilirubin >2.0 mg/dL (34.2 umol/L)
Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody Immunoglobulin M, Hepatitis B surface antigen and Hepatitis C virus antibody
Estimated Glomerular Filtration Rate <60 mL/min/1.73 m^2 (calculated by Cockcroft-Gault formula).
History of bladder cancer
Recent cardiovascular events in a patient, including any of the following: acute coronary syndrome within 2 months prior to enrollment; hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrollment; acute stroke or trans-ischemic attack within two months prior to enrollment; less than two months post coronary artery revascularization; congestive heart failure defined as New York Heart Association class IV,unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volume status throughout the study
Blood pressure at enrolment: Systolic blood pressure ≥165 mmHg and/or diastolic blood pressure ≥100 mmHg
Blood pressure at randomization: Systolic blood pressure ≥165 mmHg and/or diastolic blood pressure ≥100 mmHg
Patients who, in the judgment of the medical monitor, may be at risk for dehydration
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University, Dept. of Health and Exercise Science | Fort Collins | Colorado | 80523-1582 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Some of the participants with baseline measures collected either declined participation or were enrolled in the amended protocol NCT03180489.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Insulin Sensitivity at Week 12 | Via oral glucose tolerance test. | Data were not collected. | Posted | Baseline,12 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach Pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Research Operations | COLORADO STATE UNIVERSITY | 970-491-2242 | Laurie.Biela@colostate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 9, 2017 | Jul 30, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000068959 | Body Weight Maintenance |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D049628 | Body Size |
| D006128 | Growth |
| D048788 | Growth and Development |
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|
| Placebo | Drug |
|
| Weight maintenance | Behavioral |
|
| Ad libitum dietary intake | Behavioral |
|
| Dietary restriction | Behavioral |
|
| Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| Change From Baseline in Hunger Hormone Ghrelin at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| Change From Baseline in Satiety Hormone Leptin at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| Change From Baseline in Satiety Hormone Insulin at Week 12 | Will be analyzed using a commercially available biochemical assay. | Baseline, 12 weeks |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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 |
| OG003 | 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 |
|
| Primary | Change From Baseline in Blood Pressure at Week 12 | Posted | Mean | Standard Deviation | mmHg | Baseline, 12 weeks |
|
|
|
| Primary | Change From Baseline in Perception of Satiety at Week 12 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
|
|
|
| Primary | Change From Baseline in Perception of Hunger at Week 12 | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 weeks |
|
|
|
| Primary | Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data were not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data collection was not performed | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data collection was not performed | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Hunger Hormone Ghrelin at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data were not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data were not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data were not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data were not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Satiety Hormone Leptin at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data were not collected. | Posted | Baseline, 12 weeks |
|
|
| Primary | Change From Baseline in Satiety Hormone Insulin at Week 12 | Will be analyzed using a commercially available biochemical assay. | Data were not collected. | Posted | Baseline, 12 weeks |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | 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 | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | 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 | 0 | 2 | 0 | 2 | 1 | 2 |
| Loose Stool | General disorders | Non-systematic Assessment |
|
| Cold | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Vomiting | General disorders | Non-systematic Assessment |
|
| increase in urination | General disorders | Non-systematic Assessment |
|
| Bronchitis | General disorders | Non-systematic Assessment |
|
| Fever and sore throat | General disorders | Non-systematic Assessment |
|
| Stuffy Nose | General disorders | Non-systematic Assessment |
|
| Anxiety | General disorders | Non-systematic Assessment |
|
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| D010829 |
| Physiological Phenomena |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Diastolic Blood Pressure Change |
|
| 12 weeks |
|
| 12 weeks |
|