Weight LossPhase 2NCT03180489
Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?
A Phase 2 study testing Dapagliflozin Tablet in people with Weight Loss, run by Christopher Bell at 1 site in United States.
Trial summary
Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose co-transporter 2 inhibitors is associated with moderate weight (fat) loss, in addition to other health benefits, including decreased blood… 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 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to 21 Dec 2018
- 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
- Limited exercise participation (maximum of 3/week regularly scheduled activity sessions of < 30 minutes during the previous month).
- 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 2 weeks before study commencement. Prior use of medication or herbal preparations in the 4 weeks before study commencement that are intended for weight-loss and/or sold/marketed as weight-loss products or may alter metabolism. Permitted Prescription Drugs: Birth Control, Less than a 7 day short course of antibiotics. Note: Rifampicin is not permitted. Other medicines, such as those for gastroesophageal reflux disease, depression, and Over The Counter analgesics and allergy medications,may be allowed, but will be approved on a case-by-case basis.
- 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.
Show all 18Show fewer
- Severe renal impairment, end-stage renal disease, or dialysis.
- Pregnant or breastfeeding individual.
- 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 enrolment; hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment; acute stroke or trans-ischemic attack within two months prior to enrolment; 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 ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
- Blood pressure at randomization: Systolic blood pressure ≥165 mmHg and/or diastolic blood pressure ≥100 mmHg
- Individuals who, in the judgment of the medical monitor, may be at risk for dehydration.
- Individuals with a history of fragility fracture, or bone mineral density values reflective of risk for fracture (DEXA Z-score <or= to -2 in pre-menopausal women, and men <50, and T-score <or= to -1) will not be permitted to participate.
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
Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose co-transporter 2 inhibitors 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. We wish to compare the health benefits of dietary counseling for weight loss with and without concomitant use of an SGLT2 inhibitor.
Read the detailed description
This is a randomized, prospective, placebo-controlled, double blind, repeated measures study. 50 overweight/obese adults (body mas index > 27.5 kg/m2) will be recruited for participation and randomly assigned to one of two 12 week treatments: (1) daily oral administration of Dapagliflozin with dietary counseling to promote weight loss; or, (2) daily oral administration of a placebo with dietary counseling to promote weight loss.
- Conditions
- Weight Loss
- Being tested
- Dapagliflozin Tablet, Placebo Tablet
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin TabletDrug
Also called Farxiga
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 TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin with dietary counseling | Experimental | Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. Receives: Drug: Dapagliflozin Tablet |
| Placebo with dietary counseling | Placebo comparator | Daily oral administration of placebo tablet with dietary counseling to promote weight loss. Receives: Drug: Placebo Tablet |
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
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.
Measured: Baseline, 12 weeks
Change From Baseline in Blood Pressure at Week 12
Blood pressure was measured with an automatic machine at baseline. Numbers are reported as systolic/diastolic
Measured: Baseline, 12 weeks
Change From Baseline in Perception of Satiety at Week 12
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.
Measured: Baseline, 12 weeks
Change From Baseline in Perception of Hunger at Week 12
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.
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: Data not collected
Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Data not collected
Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: data not collected
Change From Baseline in Hunger Hormone Ghrelin at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: data not collected
Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: data not collected
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: Data not collected
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: Data not collected
Change From Baseline in Satiety Hormone Leptin at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Data not collected
Change From Baseline in Satiety Hormone Insulin at Week 12
Will be analyzed using a commercially available biochemical assay.
Measured: Data not collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start3 May 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 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
- Investigators
- Christopher Bell, Ph.D., Principal investigator, Colorado State UniversityChristopher Melby, Dr.P.H., Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180489
- Sponsor's protocol ID
- 17-7147H
- Status last verified
- Jan 2020
- First submitted
- 6 Jun 2017
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?
- ClinicalTrials.gov ID
- NCT03180489
- Acronym / sponsor ID
- 17-7147H
- Conditions
- Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 3 May 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose co-transporter 2 inhibitors 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. We wish to compare the health benefits of dietary counseling for weight loss with and without concomitant use of an SGLT2 inhibitor.
Detailed description
This is a randomized, prospective, placebo-controlled, double blind, repeated measures study. 50 overweight/obese adults (body mas index > 27.5 kg/m2) will be recruited for participation and randomly assigned to one of two 12 week treatments: (1) daily oral administration of Dapagliflozin with dietary counseling to promote weight loss; or, (2) daily oral administration of a placebo with dietary counseling to promote weight loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin with dietary counseling | Experimental | Drug: Dapagliflozin TabletDaily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss. |
| Placebo with dietary counseling | Placebo comparator | Drug: Placebo TabletDaily oral administration of placebo tablet with dietary counseling to promote weight loss. |
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
- Limited exercise participation (maximum of 3/week regularly scheduled activity sessions of < 30 minutes during the previous month).
Key exclusion criteria (18 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 2 weeks before study commencement. Prior use of medication or herbal preparations in the 4 weeks before study commencement that are intended for weight-loss and/or sold/marketed as weight-loss products or may alter metabolism. Permitted Prescription Drugs: Birth Control, Less than a 7 day short course of antibiotics. Note: Rifampicin is not permitted. Other medicines, such as those for gastroesophageal reflux disease, depression, and Over The Counter analgesics and allergy medications,may be allowed, but will be approved on a case-by-case basis.
- 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.
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 |
|---|---|---|
| Dapagliflozin TabletAlso: FarxigaDaily 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. | Drug | Dapagliflozin with dietary counseling |
| Placebo TabletDaily 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. | Drug | Placebo with dietary counseling |
Primary outcome
Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test
Time frame: Baseline, 12 weeks
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.
Change From Baseline in Blood Pressure at Week 12
Time frame: Baseline, 12 weeks
Blood pressure was measured with an automatic machine at baseline. Numbers are reported as systolic/diastolic
Change From Baseline in Perception of Satiety at Week 12
Time frame: 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.
Change From Baseline in Perception of Hunger at Week 12
Time frame: 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.
Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12
Time frame: Data not collected
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: Data not collected
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12
Time frame: data not collected
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Hunger Hormone Ghrelin at Week 12
Time frame: data not collected
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12
Time frame: data not collected
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: Data not collected
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: Data not collected
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Satiety Hormone Leptin at Week 12
Time frame: Data not collected
Will be analyzed using a commercially available biochemical assay.
Change From Baseline in Satiety Hormone Insulin at Week 12
Time frame: Data not collected
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 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christopher Bell, Ph.D. principal investigator
Colorado State University
Christopher Melby, Dr.P.H. principal investigator
Colorado State University
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 Tablet 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 18 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: finished, as of the sponsor's last update on 11 Feb 2020. 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 Feb 2020). 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 Via Oral Glucose Tolerance Test (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 11 Feb 2020.