Phase 3 N=24 Randomized Double-blind Treatment

Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

Metabolic Syndrome X

Bottom Line

View on ClinicalTrials.gov: NCT02113241 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Waist Circumference at Week 12. — 97.6; 97.2 centimeters — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dapagliflozin (Drug); Placebo (Drug)
Age: Adult · 30+ yrs
Sex: All
Sponsor: University of Guadalajara
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Waist Circumference at Week 12.	97.6; 97.2	<0.001 sig
PRIMARY Triglycerides Levels at Week 12.	1.7; 1.7	0.003 sig
PRIMARY High Density Lipoprotein (c-HDL) Levels at Week 12.	1.3; 1.3	0.161
PRIMARY Glucose Levels at Minute 0 at Week 12.	5.7; 5.8	0.067
PRIMARY Systolic Blood Pressure at Week 12.	117; 121	0.128
PRIMARY Diastolic Blood Pressure at Week 12.	76; 79	0.433
PRIMARY Insulinogenic Index (Total Insulin Secretion) at Week 12.	0.35; 0.99	<0.001 sig
PRIMARY Stumvoll Index (First Phase of Insulin Secretion) at Week 12.	1463; 2198	0.791
PRIMARY Matsuda Index (Total Insulin Sensitivity) at Week 12.	2.7; 1.6	0.075
SECONDARY Body Weight at Week 12.	81.2; 79.6	<0.001 sig
SECONDARY Body Mass Index at Week 12	32.6; 32.1	<0.001 sig
SECONDARY Fat Mass at Week 12.	32.7; 34.4	0.338
SECONDARY Total Cholesterol at Week 12	5.2; 4.9	0.049 sig
SECONDARY Low Density Lipoproteins (c-LDL) at Week 12	3.1; 2.8	0.850
SECONDARY Alanine Aminotransferase (ALT) at Week 12.	32.1; 38.1	0.006 sig
SECONDARY Aspartate Aminotransferase (AST) at Week 12.	31.1; 29.5	0.011 sig
SECONDARY Creatinine at Week 12.	0.07; 0.05	0.652
SECONDARY Uric Acid at Week 12.	243.9; 339.0	0.254
SECONDARY AUC of Glucose at Week 12.	1153; 1129	0.129
SECONDARY AUC of Insulin at Week 12.	45016; 119704	<0.001 sig
SECONDARY Glucose at Minute 30 at Week 12.	10.5; 10.0	0.392
SECONDARY Glucose at Minute 60 at Week 12.	11.1; 11.4	0.176
SECONDARY Glucose at Minute 90 at Week 12.	9.8; 9.9	0.064
SECONDARY Glucose at Minute 120 at Week 12.	8.5; 8.8	0.346

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. 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.

Eligibility Criteria

Inclusion Criteria

Patients both sexes
Age between 30 and 60 years
Metabolic Syndrome according to the IDF criteria
Waist circumference
Man ≥90 cm
Woman ≥80 cm
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

Exclusion Criteria

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02113241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.