- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02700334
Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
A randomized, double-blind, placebo-controlled clinical trial in 24 patients with a diagnosis of prediabetes in accordance with the American Diabetes Association (ADA) without treatment.
They will be assigned randomly two groups of 12 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.
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.
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 Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
This protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Jalisco
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Guadalajara, Jalisco, Mexico, 44340
- Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
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10 mg, one per day before breakfast during 12 weeks.
Other Names:
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Placebo Comparator: Placebo
Placebo capsules, one per day before breakfast during 12 weeks.
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one per day before breakfast during 12 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Glucose
Time Frame: Fasting Glucose levels at week 12
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The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
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Fasting Glucose levels at week 12
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Postprandial Glucose
Time Frame: Postprandial Glucose levels at Week 12
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Postprandial glucose will be evaluated after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12
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Postprandial Glucose levels at Week 12
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First Phase of Insulin Secretion
Time Frame: First Phase of Insulin Secretion at Week 12
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The first phase of insulin secretion will be calculated with Stumvoll index and the entered values reflect the frst 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 first phase of insulin secretion |
First Phase of Insulin Secretion at Week 12
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Total Insulin Secretion
Time Frame: Total Insulin Secretion at Week 12
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Total insulin secretion will be calculated with insulinogenic index and the entered values reflect the 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 (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion |
Total Insulin Secretion at Week 12
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Insulin Sensitivity
Time Frame: Insulin Sensitivity at Week 12
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Insulin sensitivity will be calculated with Matsuda index and the entered values reflect the 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 |
Insulin Sensitivity at Week 12
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Glycosylated Hemoglobin
Time Frame: Glycosylated Hemoglobin at Week 12
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Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12
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Glycosylated Hemoglobin at Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: Body Weight at Week 12
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The body weight will be measured with a bioimpedance balance and the entered values reflect the body weight at week 12
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Body Weight at Week 12
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Body Mass Index
Time Frame: Body Mass Index at Week 12
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Body Mas Index will be calculated with the Quetelet index formula and the entered values reflect the body mass index at week 12
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Body Mass Index at Week 12
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Total Cholesterol
Time Frame: Total Cholesterol levels at Week 12
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Total cholesterol levels will be evaluated by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
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Total Cholesterol levels at Week 12
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Triglycerides
Time Frame: Triglycerides levels at Week 12
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Triglycerides levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
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Triglycerides levels at Week 12
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High Density Lipoprotein Cholesterol (HDL-c)
Time Frame: HDL-c levels at Week 12
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HDL-c levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
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HDL-c levels at Week 12
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Alanine Aminotransferase (ALT)
Time Frame: ALT levels at Week 12
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ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12
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ALT levels at Week 12
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Aspartate Aminotransferase (AST)
Time Frame: AST levels at Week 12
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AST levels will be evaluated with enzymatic/colorimetric techniques at week 12
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AST levels at Week 12
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Creatinine
Time Frame: Creatinine levels at Week 12
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Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12
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Creatinine levels at Week 12
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Uric Acid
Time Frame: Uric Acid levels at Week 12
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Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12
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Uric Acid levels at Week 12
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Systolic Blood Pressure
Time Frame: Systolic Blood Pressure at Week 12
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Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
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Systolic Blood Pressure at Week 12
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Diastolic Blood Pressure
Time Frame: Diastolic Blood Pressure at Week 12
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Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
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Diastolic Blood Pressure at Week 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MANUEL GONZALEZ, PhD, University of Guadalajara
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Hyperinsulinism
- Hyperglycemia
- Prediabetic State
- Glucose Intolerance
- Insulin Resistance
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- Dapagliflozin
Other Study ID Numbers
- DAPA-PREDIABETES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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