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Sodium-glucose cotransporter 2 (SGLT2) inhibitors
Diabetes Medications for Prediabetes
N/A
Recruiting
Led By Ralph A DeFronzo, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening
Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months after treatment phase begins
Awards & highlights
Study Summary
This trial is testing if two different types of diabetes have different causes, and if different treatments are needed for each.
Who is the study for?
This trial is for adults aged 18-65 with pre-diabetes, specifically those with impaired fasting glucose and impaired glucose tolerance. They should have a BMI between 24-40 kg/m2 and stable weight. Participants must be in good health without major organ disease or history of heart failure, not pregnant, willing to use contraception, and not on certain medications.Check my eligibility
What is being tested?
The study tests whether Dapagliflozin, Saxagliptin, Pioglitazone, or Metformin can prevent type 2 diabetes in people with early blood sugar issues. It's based on the idea that different treatments might be needed for different types of pre-diabetes.See study design
What are the potential side effects?
Potential side effects include sensitivity reactions to the drugs tested (like rashes), possible effects on kidney function or liver enzymes, risk of low blood pressure upon standing (orthostatic hypotension), and other drug-specific risks such as urinary infections from Dapagliflozin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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My major organs are healthy based on recent exams and tests.
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I am a woman who can have children, not pregnant, and use birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months after treatment phase begins
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months after treatment phase begins
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Beta cell function
Glucose tolerance status
Insulin sensitivity
Trial Design
13Treatment groups
Active Control
Group I: Isolated IFG with DapagliflozinActive Control1 Intervention
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG < 140) will receive dapagloflozin, 10mg/day
Group II: Isolated IGT with MetforminActive Control1 Intervention
Healthy subjects with isolated IGT (FPG < 100; 2-h PG = 140-199) will receive Metformin, starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Group III: Isolated IGT with PioglitazoneActive Control1 Intervention
Healthy subjects with isolated IGT (FPG < 100; 2-h PG = 140-199) will receive pioglitazone, the dose will increase from 15 mg/day to 30 mg/day at month two
Group IV: Isolated IFG with SaxagliptinActive Control1 Intervention
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG < 140) will receive saxagliptin, 10mg/day
Group V: IGT plus IFG with SaxagliptinActive Control1 Intervention
Healthy subjects with IGT plus IFG will receive saxagliptin, 10mg/day
Group VI: IGT plus IFG with PioglitazoneActive Control1 Intervention
Healthy subjects with IGT plus IFG will receive pioglitazone, the dose will increase from 15 mg/day to 30 mg/day at month two
Group VII: Isolated IFG with PioglitazoneActive Control1 Intervention
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG < 140) will receive pioglitazone, the dose will increase from 15 mg/day to 30 mg/day at month two
Group VIII: Isolated IFG with MetforminActive Control1 Intervention
Healthy subjects with isolated IFG (FPG = 100-125; 2-h PG < 140) will receive Metformin, starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Group IX: IGT plus IFG with DapagliflozinActive Control1 Intervention
Healthy subjects with IGT plus IFG will receive dapagliflozin, 10mg/day
Group X: IGT plus IFG with MetforminActive Control1 Intervention
Healthy subjects with IGT plus IFG will receive Metformin, starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Group XI: Healthy normal glucose tolerance (NGT) subjectsActive Control1 Intervention
Subjects (Fasting Plasma Glucose or FPG < 100 mg/dl and 2-h PG < 140 mg/dl) without FH (family history) of diabetes in a first degree relative
Group XII: Isolated IGT with DapagliflozinActive Control1 Intervention
Healthy subjects with isolated IGT (FPG < 100; 2-h PG = 140-199) will receive dapagliflozin, 10 mg/day
Group XIII: Isolated IGT with SaxagliptinActive Control1 Intervention
Healthy subjects with isolated IGT (FPG < 100; 2-h PG = 140-199) will receive saxagliptin, 5 mg/day
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
453 Previous Clinical Trials
90,730 Total Patients Enrolled
American Diabetes AssociationOTHER
139 Previous Clinical Trials
98,906 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,611,996 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I haven't had any unstable illnesses in the last 3 months.I have a close family member with diabetes.I have never had heart failure.I am between 18 and 65 years old.My major organs are healthy based on recent exams and tests.I have not donated blood in the last 8 weeks.If your blood test shows high levels of creatinine (above 1.5 mg/dl for males or 1.4 mg/dl for females), you cannot participate.Your blood sugar levels are within a certain range when tested after fasting and after having a sugary drink.Your body mass index (BMI) is between 24 and 40.I am not on medication that affects my sugar levels or brain function, except for metformin or pioglitazone.I do not have any major organ system diseases.I am healthy and match a patient in age, gender, ethnicity, and BMI.You have a different schedule for eating and sleeping than usual, such as eating during the day and sleeping at night.Your liver enzymes (ALT, AST) are more than three times the normal limit.I do not have blood in my urine.I do not have a history of significant drops in blood pressure upon standing.My BMI is either below 24 or above 40.I do not have a family history of pancreatic, bladder, or breast cancer.Your weight has not changed by more than 4 pounds in the last 3 months.I am a woman who can have children, not pregnant, and use birth control.You are involved in a very intense exercise program.Your weight has been changing a lot (more than ±4 lbs) in the last 3 months.You have had a bad reaction to pioglitazone, dapagliflozin, or saxagliptin in the past.I have never had pancreatitis.My kidney function is normal or only slightly reduced.Your body mass index (BMI) is between 24 and 40.
Research Study Groups:
This trial has the following groups:- Group 1: Isolated IFG with Dapagliflozin
- Group 2: Isolated IGT with Metformin
- Group 3: Isolated IGT with Pioglitazone
- Group 4: Isolated IFG with Saxagliptin
- Group 5: IGT plus IFG with Saxagliptin
- Group 6: IGT plus IFG with Pioglitazone
- Group 7: Isolated IFG with Pioglitazone
- Group 8: Isolated IFG with Metformin
- Group 9: IGT plus IFG with Dapagliflozin
- Group 10: IGT plus IFG with Metformin
- Group 11: Healthy normal glucose tolerance (NGT) subjects
- Group 12: Isolated IGT with Dapagliflozin
- Group 13: Isolated IGT with Saxagliptin
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What condition does Isolated IGT with Saxagliptin usually address?
"Typically, Saxagliptin is prescribed to those who have not responded well to other treatments for Isolated IGT. Additionally, it can be used as an intervention for type 1 diabetes mellitus and metabolic disorders induced by physical activity."
Answered by AI
Who meets the requirements to be a participant in this medical research project?
"This clinical trial is recruiting 700 individuals aged between 18 and 65 who currently suffer from diabetes mellitus type 2. Eligible applicants must have a stable body weight (±4lbs) in the last 3 months, similar age, gender, ethnicity, BMI to their fellow participants with NGT; male or female genders are accepted; FPG < 100 mg/dl and 2-h PG < 140 mg/dl; BMI = 24-40 kg/m2; no major organ system disease as determined by physical exam, history and screening laboratory data along with contraceptive usage records such as oral contraceptives, injectable progesterone or subdermal"
Answered by AI
Is there still space available in this clinical research endeavor?
"This research endeavour is currently open for enrolment, as reported on clinicaltrials.gov; the trial was initially established in 2014 and has been revised more recently on August 29th of this year."
Answered by AI
How many participants have the capacity to join this research endeavor?
"Affirmative, data hosted on the clinicaltrials.gov website indicates that this trial is enrolling participants. The study was initially posted on January 1st 2014 and most recently updated on August 29th 2022; 700 patients are needed at a single location."
Answered by AI
Are elder patients being sought for involvement in this venture?
"To be included in this trial, participants must fit within the age parameters of 18 to 65 years old. There are 221 studies for minors and 1381 trials designed for seniors."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
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