Weight LossPhase 2NCT02520518
Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?
A Phase 2 study testing Dapagliflozin, Weight maintenance and Ad libitum dietary intake in people with Weight Loss, run by Christopher Bell at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Dapagliflozin, Weight maintenance and Ad libitum dietary intake
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Aged 18-65 years.
- No known Type 2 Diabetes
- Body mass index greater than or equal to 27.5 kg/m^2
- Sedentary (maximum of 2/week regularly scheduled activity sessions of < 20 minutes during the previous 2 years)
- Completion of a screening visit consisting of medical history, physical examination, and 12-lead electrocardiogram and blood pressure assessment at rest and during incremental exercise to volitional exhaustion (Note: Subjects with abnormal screening values may be eligible if the results are not clinically significant, as judged by the investigator or medical monitor)
- Agree to abide by the study schedule and dietary restrictions and to return for the required assessments
- Women of childbearing potential must have negative pregnancy test and be using acceptable contraception
Who cannot join
- 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
- Birth Control
- Less than 7 days, short course antibiotics. Note: Rifampin is not permitted.
- Other medicines, for Gastroesophageal Reflux Disease (GERD), depression, seasonal allergies and over-the-counter analgesics, maybe allowed, but will be approved on a case-by-case basis.
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, 80523-1582
About this study
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.
Read the detailed description
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.
- Conditions
- Weight Loss
- Being tested
- Dapagliflozin, Placebo, Weight maintenance, Ad libitum dietary intake, Dietary restriction
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Farxiga
PlaceboDrug
Weight maintenanceBehavioural
Ad libitum dietary intakeBehavioural
Dietary restrictionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dapagliflozin; Behavioral: Ad libitum dietary intake |
| 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. Receives: Drug: Dapagliflozin; Behavioral: Weight maintenance |
| 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. Receives: Drug: Placebo; Behavioral: Ad libitum dietary intake |
| 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. Receives: Drug: Placebo; Behavioral: Dietary restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Insulin Sensitivity at Week 12
Via oral glucose tolerance test.
Measured: Baseline,12 weeks
Change From Baseline in Blood Pressure at Week 12
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks
Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Baseline, 12 weeks
Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Baseline, 12 weeks
Change From Baseline in Hunger Hormone Ghrelin at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Baseline, 12 weeks
Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks
Change From Baseline in Satiety Hormone Leptin at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Baseline, 12 weeks
Change From Baseline in Satiety Hormone Insulin at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Designed a new modified/simplified protocol see NCT 03180489
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Bell
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Christopher Bell, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520518
- Sponsor's protocol ID
- 14-5531H
- Status last verified
- Dec 2018
- First submitted
- 27 Jul 2015
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?
- ClinicalTrials.gov ID
- NCT02520518
- Acronym / sponsor ID
- 14-5531H
- Conditions
- Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Designed a new modified/simplified protocol see NCT 03180489
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Aug 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin: ad libitum dietary intake | Experimental | Drug: Dapagliflozin, Behavioral: Ad libitum dietary intakeDaily 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 | Drug: Dapagliflozin, Behavioral: Weight maintenanceDaily 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 | Drug: Placebo, Behavioral: Ad libitum dietary intakeDaily 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 | Drug: Placebo, Behavioral: Dietary restrictionDaily 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of informed consent prior to any study specific procedures.
- Aged 18-65 years.
- No known Type 2 Diabetes
- Body mass index greater than or equal to 27.5 kg/m^2
- Sedentary (maximum of 2/week regularly scheduled activity sessions of < 20 minutes during the previous 2 years)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinAlso: Farxiga | Drug | Dapagliflozin: ad libitum dietary intake, Dapagliflozin: weight maintenance |
| Placebo | Drug | Placebo: ad libitum dietary intake, Placebo: dietary restriction |
| Weight maintenance | Behavioural | Dapagliflozin: weight maintenance |
| Ad libitum dietary intake | Behavioural | Dapagliflozin: ad libitum dietary intake, Placebo: ad libitum dietary intake |
| Dietary restriction | Behavioural | Placebo: dietary restriction |
Primary outcome
Change From Baseline in Insulin Sensitivity at Week 12
Time frame: Baseline,12 weeks
Via oral glucose tolerance test.
Change From Baseline in Blood Pressure at Week 12
Time frame: Baseline, 12 weeks
Change From Baseline in Perception of Satiety at Week 12
Time frame: 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.
Change From Baseline in Perception of Hunger at Week 12
Time frame: 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.
Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Hunger Hormone Ghrelin at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Satiety Hormone Leptin at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Satiety Hormone Insulin at Week 12
Time frame: Baseline, 12 weeks
Will be analyzed using a commercially available biochemical assay.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin, Weight maintenance and Ad libitum dietary intake in people with Weight Loss, run by Christopher Bell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Insulin Sensitivity at Week 12 (time frame: Baseline,12 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.