ObesityPhase 4NCT03710460
Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity
A Phase 4 study testing Dapagliflozin, Dapagliflozin plus Metformin XR and Metformin XR in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Obesity has increased to alarming levels in the world. Currently it is estimated that it occurs in a third of the world's population and it is expected that by 2030, 20% of the world's adult population will suffer from obesity and 38% will be overweight, and it is important to highlight that Mexico is among the first… Read more about this study
- Who is it for?
- Ages 31 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dapagliflozin, Dapagliflozin plus Metformin XR and Metformin XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jul 2019to 30 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 31 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed grade 1 obesity according to the WHO criteria:
- -Body Mass Index (BMI) between 30 to 34.9 kg/m²
- No pharmacological treatment for obesity
- Stable weight during the last 3 months
Who cannot join
- Pregnancy or breast-feeding
- History of kidney or liver disease
- Drugs or supplements consumption with proven properties that modify the behavior of obesity
- Total cholesterol >240 mg/dL
- Triglycerides >500mg/dL
- Glucose ≥126 mg/dL or HbA1C ≥6.5%.
- Patients who smoke daily for the last 6 months
- Hypersensitivity to dapagliflozin or metformin XR
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
Manuel Gonzalez, PhD, +52-10-58-52-00 ext. 34212, uiec@prodigy.net.mx
About this study
Official title: Effect of the Administration of the Combination of Dapagliflozin Plus Metformin XR Versus Monotherapies on Anthropometric Indicators in Patients With Grade 1 Obesity.
Obesity has increased to alarming levels in the world. Currently it is estimated that it occurs in a third of the world's population and it is expected that by 2030, 20% of the world's adult population will suffer from obesity and 38% will be overweight, and it is important to highlight that Mexico is among the first in obesity in adults and children.
Obesity leads to the development of diseases such as diabetes mellitus type 2, dyslipidemias, metabolic syndrome, heart problems, among others.
Read more
The treatment for obesity in the first instance are changes in lifestyle, changes in diet and exercise that have shown, in most patients, have little long-term adherence. There are also drugs that promote weight loss by modifying the appetite or absorption of macronutrients.
Dapagliflozin plus metformin XR is a medicine composed with an oral antidiabetic of the group of inhibitors of SGLT2 that has shown to have significant side effects in the weight reduction and visceral adiposity in people with obesity and in patients with diabetes mellitus type 2, it is also composed with metformin which also has effects on weight loss in people with and without type 2 diabetes mellitus.
For these reasons, evaluating this compound drug in people with obesity could provide high impact information as a complement for the treatment of this condition when compared to the effects produced by monotherapies.
Read the detailed description
A double-blind, randomized clinical trial of three pharmacological groups in 33 patients with a diagnosis of grade 1 obesity in accordance with the World Health Organization (WHO) without treatment.
They will be assigned randomly three groups of 11 patients, each one will receive 10 mg of dapaglizflozin (Forxiga, Astra Zeneca), 1000 mg of metformin XR or 10/1000 mg of dapagliflozin plus metformin XR, one time per day before having break-fast during 12 weeks.
The body weight, body mass index (BMI), adiposity %, visceral adiposity, fat mass, lean mass, waist circunference,waist-hip index, arterial pressure, and laboratory parameters as a glucose, triglicerides, cholesterol, High density lipoprotein (c-HDL), low density lipoprotein (c-LDL), uric acid, creatinin, C reactive protein, adiponectin and interleukin 10, leptin and TNF-∝will be measures.
This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Kruskal-Wallis Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
- Conditions
- Obesity
- Being tested
- Dapagliflozin, Dapagliflozin plus Metformin XR, Metformin XR
- Keywords
- Obesity, Dapagliflozin, Metformin XR, Visceral adiposity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
10 mg, one per day before breakfast during 12 weeks.
Dapagliflozin plus Metformin XRDrug
Also called XigDuo
10/1000 mg, one per day before breakfast during 12 weeks.
Metformin XRDrug
1000 mg, one per day before breakfast during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Receives: Drug: Dapagliflozin |
| Dapagliflozin plus metformin XR | Experimental | Dapagliflozin plus metformin XR capsules, 10/1000 mg, one per day before breakfast during 12 weeks. Receives: Drug: Dapagliflozin plus Metformin XR |
| Metformin XR | Experimental | Metformin XR capsules, 1000 mg, one per day before breakfast during 12 weeks. Receives: Drug: Metformin XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
The body weight will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
Measured: Baseline to week 12
Body Mass Index
Body Mas Index will be calculated at baseline to week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12
Measured: Baseline to week 12
Adiposity percentage
The adiposity percentage will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the adiposity percentage at week 12
Measured: Baseline, week 4, week 8 and week 12
Visceral adiposity
Visceral adiposity will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the visceral adiposity in square meter at week 12
Measured: Baseline to week 12
Lean mass
The lean mass will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the lean mass at week 12
Measured: Baseline to week 12
Fat mass
The fat mass will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the fat mass at week 12
Measured: Baseline to week 12
Waist circumference
Waist circumference will be evaluated with the method proposed by ISAK.
Measured: Baseline to week 12
Waist-hip ratio
The waist-hip ratio will be calculated as waist measurement divided by hip measurement
Measured: Baseline to week 12
Secondary outcomes (14)
Interleukin 10 levels IL-10
Interleukin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total interleukin 10 level at week 12
Measured: Baseline and week 12
Adiponectin levels.
adiponectin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorben Assayed (ELISA) the entered values reflect the total adiponectin levels at week 12
Measured: Baseline and week 12
C-reactive protein levels
C-reactive protein levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total C-reactive protein levels levels at week 12
Measured: Baseline and week 12
Leptin levels
Leptin levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total leptin levels levels at week 12
Measured: Baseline and week 12
TNF-α levels
Tumor necrosis factor alpha (TNF-α) levels will be evaluated at baseline and week 12 by Enzyme-Linked ImmunoSorbent Assayed (ELISA) the entered values reflect the total TNF-αl levels levels at week 12
Measured: Baseline and week 12
Total cholesterol
Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Measured: Baseline to Week 12
HDL cholesterol
High density lipoprotein cholesterol (HDL-C)
Measured: Total high density lipoprotein cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the high density lipoprotein cholesterol level at week 12
LDL cholesterol
Low density lipoprotein cholesterol (LDL-C)
Measured: Total low density lipoprotein cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the low density lipoprotein cholesterol level at week 12
Triglycerides levels
Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Measured: Baseline to Week 12
Fasting glucose levels
The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12.
Measured: Baseline to Week 12
Creatinine levels
Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Measured: Baseline to Week 12
Uric acid levels
Uric acid levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Measured: Baseline to Week 12
Systolic blood pressure
blood pressure will be measured at baseline week 4, week 8 and week 12 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).
Measured: Baseline, week 4, week 8 and week 12
Diastolic blood pressure
blood pressure will be measured at baseline week 4, week 8 and week 12 with a digital sphygmomanometer. Values will be expressed in millimeters of mercury (mmHg).
Measured: Baseline, week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start30 Jul 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina Griselda Pérez Rubio, University of Guadalajara
- Investigators
- Manuel Gonzalez Ortiz, MD MSc Phd, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710460
- Sponsor's protocol ID
- Dapa-MetforminXR in Obesity
- Status last verified
- Jun 2022
- First submitted
- 4 Oct 2018
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of the Combination of Dapagliflozin Plus Metformin XR Versus Monotherapies on Anthropometric Indicators in Patients With Grade 1 Obesity.
- ClinicalTrials.gov ID
- NCT03710460
- Acronym / sponsor ID
- Dapa-MetforminXR in Obesity
- Conditions
- Obesity
- Keywords
- Obesity, Dapagliflozin, Metformin XR, Visceral adiposity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity has increased to alarming levels in the world. Currently it is estimated that it occurs in a third of the world's population and it is expected that by 2030, 20% of the world's adult population will suffer from obesity and 38% will be overweight, and it is important to highlight that Mexico is among the first in obesity in adults and children.
Obesity leads to the development of diseases such as diabetes mellitus type 2, dyslipidemias, metabolic syndrome, heart problems, among others.
The treatment for obesity in the first instance are changes in lifestyle, changes in diet and exercise that have shown, in most patients, have little long-term adherence. There are also drugs that promote weight loss by modifying the appetite or absorption of macronutrients.
Dapagliflozin plus metformin XR is a medicine composed with an oral antidiabetic of the group of inhibitors of SGLT2 that has shown to have significant side effects in the weight reduction and visceral adiposity in people with obesity and in patients with diabetes mellitus type 2, it is also composed with metformin which also has effects on weight loss in people with and without type 2 diabetes mellitus.
For these reasons, evaluating this compound drug in people with obesity could provide high impact information as a complement for the treatment of this condition when compared to the effects produced by monotherapies.
Detailed description
A double-blind, randomized clinical trial of three pharmacological groups in 33 patients with a diagnosis of grade 1 obesity in accordance with the World Health Organization (WHO) without treatment.
They will be assigned randomly three groups of 11 patients, each one will receive 10 mg of dapaglizflozin (Forxiga, Astra Zeneca), 1000 mg of metformin XR or 10/1000 mg of dapagliflozin plus metformin XR, one time per day before having break-fast during 12 weeks.
The body weight, body mass index (BMI), adiposity %, visceral adiposity, fat mass, lean mass, waist circunference,waist-hip index, arterial pressure, and laboratory parameters as a glucose, triglicerides, cholesterol, High density lipoprotein (c-HDL), low density lipoprotein (c-LDL), uric acid, creatinin, C reactive protein, adiponectin and interleukin 10, leptin and TNF-∝will be measures.
This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Kruskal-Wallis Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. |
| Dapagliflozin plus metformin XR | Experimental | Drug: Dapagliflozin plus Metformin XRDapagliflozin plus metformin XR capsules, 10/1000 mg, one per day before breakfast during 12 weeks. |
| Metformin XR | Experimental | Drug: Metformin XRMetformin XR capsules, 1000 mg, one per day before breakfast during 12 weeks. |
Who may qualify
- Ages
- 31 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed grade 1 obesity according to the WHO criteria:
- -Body Mass Index (BMI) between 30 to 34.9 kg/m²
- No pharmacological treatment for obesity
- Stable weight during the last 3 months
Key exclusion criteria (8 listed)
- Pregnancy or breast-feeding
- History of kidney or liver disease
- Drugs or supplements consumption with proven properties that modify the behavior of obesity
- Total cholesterol >240 mg/dL
- Triglycerides >500mg/dL
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: Forxiga10 mg, one per day before breakfast during 12 weeks. | Drug | Dapagliflozin |
| Dapagliflozin plus Metformin XRAlso: XigDuo10/1000 mg, one per day before breakfast during 12 weeks. | Drug | Dapagliflozin plus metformin XR |
| Metformin XR1000 mg, one per day before breakfast during 12 weeks. | Drug | Metformin XR |
Primary outcome
Body Weight
Time frame: Baseline to week 12
The body weight will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
Body Mass Index
Time frame: Baseline to week 12
Body Mas Index will be calculated at baseline to week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12
Adiposity percentage
Time frame: Baseline, week 4, week 8 and week 12
The adiposity percentage will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the adiposity percentage at week 12
Visceral adiposity
Time frame: Baseline to week 12
Visceral adiposity will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the visceral adiposity in square meter at week 12
Lean mass
Time frame: Baseline to week 12
The lean mass will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the lean mass at week 12
Fat mass
Time frame: Baseline to week 12
The fat mass will be measured at baseline to week 12 with a bioimpedance balance and the entered values reflect the fat mass at week 12
Waist circumference
Time frame: Baseline to week 12
Waist circumference will be evaluated with the method proposed by ISAK.
Waist-hip ratio
Time frame: Baseline to week 12
The waist-hip ratio will be calculated as waist measurement divided by hip measurement
14 secondary outcomes
Interleukin 10 levels IL-10
Time frame: Baseline and week 12
Adiponectin levels.
Time frame: Baseline and week 12
C-reactive protein levels
Time frame: Baseline and week 12
Leptin levels
Time frame: Baseline and week 12
TNF-α levels
Time frame: Baseline and week 12
Total cholesterol
Time frame: Baseline to Week 12
HDL cholesterol
Time frame: Total high density lipoprotein cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the high density lipoprotein cholesterol level at week 12
LDL cholesterol
Time frame: Total low density lipoprotein cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the low density lipoprotein cholesterol level at week 12
Triglycerides levels
Time frame: Baseline to Week 12
Fasting glucose levels
Time frame: Baseline to Week 12
Creatinine levels
Time frame: Baseline to Week 12
Uric acid levels
Time frame: Baseline to Week 12
Systolic blood pressure
Time frame: Baseline, week 4, week 8 and week 12
Diastolic blood pressure
Time frame: Baseline, week 4, week 8 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
Manuel Gonzalez Ortiz, MD MSc Phd principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin, Dapagliflozin plus Metformin XR and Metformin XR in people with Obesity, run by University of Guadalajara at 1 site in Mexico.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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 Mexico. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Gonzalez Ortiz, MD MSc Phd (+523310585200 ext. 34212, uiec@prodigy.net.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Baseline to week 12). The study lists 8 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 23 May 2023.