Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: testing Dapagliflozin for Diabetes Mellitus, Type 2

HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.

Official registry: https://clinicaltrials.gov/study/NCT02969798 · The University of Texas Health Science Center at San Antonio · enrollment listed as 700

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Dapagliflozin, Saxagliptin, or Pioglitazone. The registry lists allocation as randomized. HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies.

They plan to enroll about 700 people at San Antonio. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Interventions: Dapagliflozin, Saxagliptin, Pioglitazone, Metformin

Primary outcome (registry wording): Beta cell function

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and body-mass index (BMI) to IGT and IFG subjects
  • Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening
  • FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl
  • Stable body weight (±4lbs) over the preceding 3 months
  • Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
  • Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):
  • Injectable progesterone

Public study contact (from the registry)

Ralph A DeFronzo, MD

210-567-6691

defronzo@uthscsa.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseMontreal, Quebec
Not a traditional drug phase: Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE) for Nonalcoholic Fatty Liver Disease (NAFLD)

Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).

NCT03572465 · Official ClinicalTrials.gov record · Centre hospitalier de l'Université de Montréal (CHUM)

FAQ about this NCT record

Is NCT02969798 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT02969798?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT02969798?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary