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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

Must not have

Subjects with evidence or prior history of heart failure will be excluded

Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after treatment phase begins

Awards & highlights

Approved for 20 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had heart failure.

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I am not on medication that affects my sugar levels or brain function, except for metformin or pioglitazone.

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I do not have blood in my urine.

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I do not have a history of significant drops in blood pressure upon standing.

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My BMI is either below 24 or above 40.

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I do not have a family history of pancreatic, bladder, or breast cancer.

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I have never had pancreatitis.

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My kidney function is normal or only slightly reduced.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after treatment phase begins for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beta cell function

Glucose tolerance status

Insulin sensitivity

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met