- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03180489
Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?
January 31, 2020 updated by: Christopher Bell
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523-1582
- Colorado State University, Dept. of Health and Exercise Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dapagliflozin with dietary counseling
Daily oral administration of dapagliflozin tablet with dietary counseling to promote weight loss.
|
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.
Other Names:
|
Placebo Comparator: Placebo with dietary counseling
Daily oral administration of placebo tablet with dietary counseling to promote weight loss.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12 weeks
|
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
|
Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
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.
|
Baseline, 12 weeks
|
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.
|
Data not collected
|
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.
|
Data not collected
|
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.
|
data not collected
|
Change From Baseline in Hunger Hormone Ghrelin at Week 12
Time Frame: data not collected
|
Will be analyzed using a commercially available biochemical assay.
|
data not collected
|
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.
|
data not collected
|
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.
|
Data not collected
|
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.
|
Data not collected
|
Change From Baseline in Satiety Hormone Leptin at Week 12
Time Frame: Data not collected
|
Will be analyzed using a commercially available biochemical assay.
|
Data not collected
|
Change From Baseline in Satiety Hormone Insulin at Week 12
Time Frame: Data not collected
|
Will be analyzed using a commercially available biochemical assay.
|
Data not collected
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Bell, Ph.D., Colorado State University
- Principal Investigator: Christopher Melby, Dr.P.H., Colorado State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 3, 2017
Primary Completion (Actual)
December 21, 2018
Study Completion (Actual)
December 21, 2018
Study Registration Dates
First Submitted
June 6, 2017
First Submitted That Met QC Criteria
June 6, 2017
First Posted (Actual)
June 8, 2017
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
January 31, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-7147H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Weight Loss
-
United States Army Research Institute of Environmental...USDA Grand Forks Human Nutrition Research Center; Eastern Michigan UniversityCompletedWeight Loss | Bone Loss | Muscle LossUnited States
-
Case Comprehensive Cancer CenterUniversity Hospitals Seidman Cancer CenterRecruitingUnintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking CombinUnintended Weight LossUnited States
-
Zhen Jun WangUnknownSleeve Gastrectomy | Excessive Weight Loss | Total Weight Loss | Jejunojejunal Bypass | UncutChina
-
HealthPartners InstituteNational Cancer Institute (NCI)Completed
-
Dana-Farber Cancer InstituteCompletedWeight Loss Program After Cancer DiagnosisUnited States
-
Medical University of ViennaCompleted
-
Power Life Sciences Inc.Not yet recruitingGastric Bypass | Weight Loss Surgery
-
University at BuffaloHarvard Medical School (HMS and HSDM)TerminatedWeight Loss | Appetite LossUnited States
-
Duke UniversityNational Institute on Aging (NIA)Suspended
-
Drexel UniversityUniversity of PennsylvaniaCompletedObesity | Overweight | Weight Loss MaintenanceUnited States
Clinical Trials on Dapagliflozin Tablet
-
Daewoong Pharmaceutical Co. LTD.Active, not recruitingGlucose Metabolism Disorders | Diabetes Mellitus, Type 2 | Diabetes Mellitus | Endocrine System Diseases | Metabolic DiseaseChina
-
AstraZenecaBristol-Myers SquibbCompletedType 2 Diabetes MellitusUnited Kingdom
-
University Health Network, TorontoRecruitingType 2 Diabetes | Kidney Transplant Recipients | Post-transplant Diabetes MellitusCanada
-
AstraZenecaRecruitingLiver CirrhosisItaly, Japan, Germany, Belgium, Poland, Australia, United States, United Kingdom, Czechia, Slovakia
-
Saint Luke's Health SystemCompletedChronic Heart Failure With Preserved Systolic FunctionUnited States
-
AstraZenecaCompletedType 1 Diabetes MellitusJapan
-
The University of Texas Health Science Center at...National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedDiabetes Mellitus, Type 2United States
-
AstraZenecaRecruitingLiver CirrhosisSpain, Denmark, Germany, United States, China, Australia, Belgium, Netherlands, Switzerland, Austria, Taiwan, Canada, Czechia
-
University of LeicesterAstraZeneca; Royal Surrey County Hospital NHS Foundation TrustCompletedThe Effect of a SGLT2 Inhibitor on Glucose Flux, Lipolysis and Exercise in Type 2 Diabetes (SINGLED)Type 2 DiabetesUnited Kingdom
-
AstraZenecaCompleted