Phase 4 N=24 Randomized Double-blind Treatment

Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes

Prediabetes · Impaired Fasting Glucose · Impaired Glucose Tolerance

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View on ClinicalTrials.gov: NCT02700334 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Fasting Glucose — 5.1; 5.9 mmol/L — p=0.005

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dapagliflozin (Drug); Placebo (Drug)
Age: Adult · 30+ yrs
Sex: All
Sponsor: University of Guadalajara
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Fasting Glucose	5.1; 5.9	0.005 sig
PRIMARY Postprandial Glucose	8.4; 8.7	0.093
PRIMARY First Phase of Insulin Secretion	1096; 1379	0.878
PRIMARY Total Insulin Secretion	0.50; 0.67	0.959
PRIMARY Insulin Sensitivity	2.63; 1.94	0.005 sig
PRIMARY Glycosylated Hemoglobin	5.7; 5.9	0.331
SECONDARY Body Weight	77.8; 82.5	0.005 sig
SECONDARY Body Mass Index	29.2; 32.6	0.005 sig
SECONDARY Total Cholesterol	4.8; 4.7	0.575
SECONDARY Triglycerides	1.5; 1.6	0.314
SECONDARY High Density Lipoprotein Cholesterol (HDL-c)	1.5; 1.6	0.721
SECONDARY Alanine Aminotransferase (ALT)	29.3; 27.7	0.066
SECONDARY Aspartate Aminotransferase (AST)	29.3; 27.7	0.333
SECONDARY Creatinine	79.6; 61.9	0.859
SECONDARY Uric Acid	261.7; 303.4	0.009 sig
SECONDARY Systolic Blood Pressure	124; 123	0.919
SECONDARY Diastolic Blood Pressure	77; 74	0.720

Summary

Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of progression type 2 diabetes mellitus (T2DM). Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2) co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion through urine, so that the blood glucose is improved in patients with T2DM. Although this mechanism is independent of insulin, there are evidence of improved secretion and insulin sensitivity, so it is interesting to assess these effects in patients with prediabetes, as potential therapy for treating such disorders and prevent progression to T2DM. The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and insulin sensitivity in patients with prediabetes. The investigators hypothesis is that the administration of dapagliflozin improve insulin secretion and insulin sensitivity in patients with prediabetes.

Eligibility Criteria

Inclusion Criteria

Patients both sexes
Age between 30 and 60 years
Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
Informed consent signed

Exclusion Criteria

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to ingredients of intervention
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Diabetes diagnosis
Previous treatment for glucose
Body Mass Index ≥35 kg/m2
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 (NCT02700334). 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.