Metabolic Syndrome XPhase 2/3NCT02113241
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
A Phase 2/3 study testing Dapagliflozin in people with Metabolic Syndrome X, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 2/3
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients both sexes
- Age between 30 and 60 years
- Metabolic Syndrome according to the IDF criteria
- Waist circumference
- Man ≥90 cm
- Woman ≥80 cm
Show all 14Show fewer
- And two of the following criteria
- High density lipoprotein
- Man ≤40 mg/dL
- Woman ≤50 mg/dL
- Fasting glucose ≥100 mg/dL
- Triglycerides ≥150 mg/dL
- Blood pressure ≥130/85 mmHg
- Informed consent signed
Who cannot join
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to SGLT2 inhibitors
- Physical impossibility for taking pills
- Known uncontrolled renal, hepatic, heart or thyroid diseased
- Previous treatment for the metabolic syndrome components
Show all 12Show fewer
- Body Mass Index ≥39.9 kg/m2
- Fasting glucose ≥126 mg/dL
- Triglycerides ≥500 mg/dL
- Total cholesterol ≥240 mg/dL
- Low density lipoprotein (c-LDL) ≥190 mg/dL
- Blood Pressure ≥140/90 mmHg
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
About this study
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL).
Read more
The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load.
12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months.
The remaining 12 patients will receive placebo at the same dose.
There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Results will be presented as mean and standard deviation. Intra and inter group differences are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 it's going to be considered significant.
- Conditions
- Metabolic Syndrome X
- Being tested
- Dapagliflozin, Placebo
- Keywords
- metabolic syndrome, forxiga, dapagliflozin, insulin secretion, insulin sensitivity
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
PlaceboDrug
Also called Calcined magnesium
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Placebo capsules, 10 mg, one per day before breakfast during 90 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumference at Week 12.
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques.
Measured: Week 12
Triglycerides Levels at Week 12.
The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques.
Measured: Week 12
High Density Lipoprotein (c-HDL) Levels at Week 12.
The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Measured: Week 12
Glucose Levels at Minute 0 at Week 12.
The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Measured: Week 12
Systolic Blood Pressure at Week 12.
The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Measured: Week 12
Diastolic Blood Pressure at Week 12.
The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Measured: Week 12
Insulinogenic Index (Total Insulin Secretion) at Week 12.
The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.
Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Measured: Week 12
Stumvoll Index (First Phase of Insulin Secretion) at Week 12.
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.
First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Measured: Week 12
Matsuda Index (Total Insulin Sensitivity) at Week 12.
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12.
Measured: Week 12
Secondary outcomes (15)
Body Weight at Week 12.
The weight it's going to be measured at week 12 with a bioimpedance balance.
Measured: Week 12
Body Mass Index at Week 12
The Body Mass index it's going to be calculated at week 12 with the Quetelet index.
Measured: Week 12
Fat Mass at Week 12.
The fat mass is going to be evaluated at week 12 through bioimpedance.
Measured: Week 12
Total Cholesterol at Week 12
The total cholesterol will be estimated by standardized techniques at week 12.
Measured: Week 12
Low Density Lipoproteins (c-LDL) at Week 12
The c-LDL levels are going to be measured at week 12 with standardized techniques.
Measured: Week 12
Alanine Aminotransferase (ALT) at Week 12.
The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques.
Measured: Week 12.
Aspartate Aminotransferase (AST) at Week 12.
The hepatic transaminase AST will be evaluated with standardized methods at week 12
Measured: Week 12
Creatinine at Week 12.
The creatinine levels are going to be measured at week 12 with standardized techniques.
Measured: Week 12.
Uric Acid at Week 12.
The uric acid levels are going to be measured at week 12 with standardized techniques.
Measured: Week 12.
AUC of Glucose at Week 12.
The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12
Measured: Week 12
AUC of Insulin at Week 12.
The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12
Measured: Week 12
Glucose at Minute 30 at Week 12.
The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Measured: Week 12
Glucose at Minute 60 at Week 12.
The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Measured: Week 12
Glucose at Minute 90 at Week 12.
The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Measured: Week 12
Glucose at Minute 120 at Week 12.
The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
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.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- MANUEL GONZALEZ, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113241
- Sponsor's protocol ID
- DAPA-MS
- Status last verified
- Oct 2020
- First submitted
- 8 Apr 2014
- Last updated
- 28 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.
PubMed 22238392Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012 Jul;35(7):1473-8. doi: 10.2337/dc11-1693. Epub 2012 Mar 23.
PubMed 22446170Chao EC. Dapagliflozin: an evidence-based review of its potential in the treatment of type-2 diabetes. Core Evid. 2012;7:21-8. doi: 10.2147/CE.S16359. Epub 2012 Jun 1.
PubMed 22701099Kasichayanula S, Liu X, Lacreta F, Griffen SC, Boulton DW. Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2. Clin Pharmacokinet. 2014 Jan;53(1):17-27. doi: 10.1007/s40262-013-0104-3.
PubMed 24105299Yang L, Li H, Li H, Bui A, Chang M, Liu X, Kasichayanula S, Griffen SC, Lacreta FP, Boulton DW. Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Clin Ther. 2013 Aug;35(8):1211-1222.e2. doi: 10.1016/j.clinthera.2013.06.017. Epub 2013 Aug 2.
PubMed 23910664Obermeier M, Yao M, Khanna A, Koplowitz B, Zhu M, Li W, Komoroski B, Kasichayanula S, Discenza L, Washburn W, Meng W, Ellsworth BA, Whaley JM, Humphreys WG. In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Drug Metab Dispos. 2010 Mar;38(3):405-14. doi: 10.1124/dmd.109.029165. Epub 2009 Dec 8.
PubMed 19996149Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.
PubMed 23210765Kilov G, Leow S, Thomas M. SGLT2 inhibition with dapagliflozin -- a novel approach for the management of type 2 diabetes. Aust Fam Physician. 2013 Oct;42(10):706-10.
PubMed 24130972Kaku K, Inoue S, Matsuoka O, Kiyosue A, Azuma H, Hayashi N, Tokudome T, Langkilde AM, Parikh S. Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2013 May;15(5):432-40. doi: 10.1111/dom.12047. Epub 2013 Jan 25.
PubMed 23194084Zhang L, Feng Y, List J, Kasichayanula S, Pfister M. Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Diabetes Obes Metab. 2010 Jun;12(6):510-6. doi: 10.1111/j.1463-1326.2010.01216.x.
PubMed 20518806Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127. Epub 2013 Jun 5.
PubMed 23668478Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21.
PubMed 20566676Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.
PubMed 23906445Merovci A, Solis-Herrera C, Daniele G, Eldor R, Fiorentino TV, Tripathy D, Xiong J, Perez Z, Norton L, Abdul-Ghani MA, DeFronzo RA. Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. J Clin Invest. 2014 Feb;124(2):509-14. doi: 10.1172/JCI70704. Epub 2014 Jan 27.
PubMed 24463448
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
- ClinicalTrials.gov ID
- NCT02113241
- Acronym / sponsor ID
- DAPA-MS
- Conditions
- Metabolic Syndrome X
- Keywords
- metabolic syndrome, forxiga, dapagliflozin, insulin secretion, insulin sensitivity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 8 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL).
The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load.
12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months.
The remaining 12 patients will receive placebo at the same dose.
There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Results will be presented as mean and standard deviation. Intra and inter group differences are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 it's going to be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules, 10 mg, one per day before breakfast during 90 days. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients both sexes
- Age between 30 and 60 years
- Metabolic Syndrome according to the IDF criteria
- Waist circumference
- Man ≥90 cm
Key exclusion criteria (12 listed)
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to SGLT2 inhibitors
- Physical impossibility for taking pills
- Known uncontrolled renal, hepatic, heart or thyroid diseased
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: ForxigaDapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. | Drug | Dapagliflozin |
| PlaceboAlso: Calcined magnesiumPlacebo capsules, 10 mg, one per day before breakfast during 90 days. | Drug | Placebo |
Primary outcome
Waist Circumference at Week 12.
Time frame: Week 12
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques.
Triglycerides Levels at Week 12.
Time frame: Week 12
The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques.
High Density Lipoprotein (c-HDL) Levels at Week 12.
Time frame: Week 12
The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Glucose Levels at Minute 0 at Week 12.
Time frame: Week 12
The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Systolic Blood Pressure at Week 12.
Time frame: Week 12
The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Diastolic Blood Pressure at Week 12.
Time frame: Week 12
The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Insulinogenic Index (Total Insulin Secretion) at Week 12.
Time frame: Week 12
The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Stumvoll Index (First Phase of Insulin Secretion) at Week 12.
Time frame: Week 12
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Matsuda Index (Total Insulin Sensitivity) at Week 12.
Time frame: Week 12
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity at week 12.
15 secondary outcomes
Body Weight at Week 12.
Time frame: Week 12
Body Mass Index at Week 12
Time frame: Week 12
Fat Mass at Week 12.
Time frame: Week 12
Total Cholesterol at Week 12
Time frame: Week 12
Low Density Lipoproteins (c-LDL) at Week 12
Time frame: Week 12
Alanine Aminotransferase (ALT) at Week 12.
Time frame: Week 12.
Aspartate Aminotransferase (AST) at Week 12.
Time frame: Week 12
Creatinine at Week 12.
Time frame: Week 12.
Uric Acid at Week 12.
Time frame: Week 12.
AUC of Glucose at Week 12.
Time frame: Week 12
AUC of Insulin at Week 12.
Time frame: Week 12
Glucose at Minute 30 at Week 12.
Time frame: Week 12
Glucose at Minute 60 at Week 12.
Time frame: Week 12
Glucose at Minute 90 at Week 12.
Time frame: Week 12
Glucose at Minute 120 at Week 12.
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22238392Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11.
- Background: PubMed 22446170Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012 Jul;35(7):1473-8. doi: 10.2337/dc11-1693. Epub 2012 Mar 23.
- Background: PubMed 22701099Chao EC. Dapagliflozin: an evidence-based review of its potential in the treatment of type-2 diabetes. Core Evid. 2012;7:21-8. doi: 10.2147/CE.S16359. Epub 2012 Jun 1.
- Background: PubMed 24105299Kasichayanula S, Liu X, Lacreta F, Griffen SC, Boulton DW. Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2. Clin Pharmacokinet. 2014 Jan;53(1):17-27. doi: 10.1007/s40262-013-0104-3.
- Background: PubMed 23910664Yang L, Li H, Li H, Bui A, Chang M, Liu X, Kasichayanula S, Griffen SC, Lacreta FP, Boulton DW. Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Clin Ther. 2013 Aug;35(8):1211-1222.e2. doi: 10.1016/j.clinthera.2013.06.017. Epub 2013 Aug 2.
- Background: PubMed 19996149Obermeier M, Yao M, Khanna A, Koplowitz B, Zhu M, Li W, Komoroski B, Kasichayanula S, Discenza L, Washburn W, Meng W, Ellsworth BA, Whaley JM, Humphreys WG. In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Drug Metab Dispos. 2010 Mar;38(3):405-14. doi: 10.1124/dmd.109.029165. Epub 2009 Dec 8.
- Background: PubMed 23210765Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.
- Background: PubMed 24130972Kilov G, Leow S, Thomas M. SGLT2 inhibition with dapagliflozin -- a novel approach for the management of type 2 diabetes. Aust Fam Physician. 2013 Oct;42(10):706-10.
- Background: PubMed 23194084Kaku K, Inoue S, Matsuoka O, Kiyosue A, Azuma H, Hayashi N, Tokudome T, Langkilde AM, Parikh S. Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2013 May;15(5):432-40. doi: 10.1111/dom.12047. Epub 2013 Jan 25.
- Background: PubMed 20518806Zhang L, Feng Y, List J, Kasichayanula S, Pfister M. Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Diabetes Obes Metab. 2010 Jun;12(6):510-6. doi: 10.1111/j.1463-1326.2010.01216.x.
- Background: PubMed 23668478Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127. Epub 2013 Jun 5.
- Background: PubMed 20566676Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21.
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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, 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 2/3 study testing Dapagliflozin in people with Metabolic Syndrome X, 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 14 inclusion and 12 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 28 Oct 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 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. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Oct 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?
Waist Circumference at Week 12. (time frame: Week 12). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113241, which also lists 14 linked publications.
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 28 Oct 2020.