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New treatment option for Diabetes Mellitus, Type 2
Official title Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
ClinicalTrials.gov ID: NCT02969798
What this study is testing
What is Dapagliflozin?
Dapagliflozin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetes mellitus, type 2.
Also referred to as farxiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- NGT people will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG people
- Male or female people between the ages of 18 and 65 years of age, inclusive, at Screening.
- FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl
- BMI = 24-40 kg/m2;
- Stable body weight (±4lbs) over the preceding 3 months
You likely can't join if
- Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or...
- people with a family history of diabetes in a first degree relative
- BMI of less than 24 or greater than 40 kg/m2
- Unstable body weight (change of greater than ±4lbs over the preceding 3 months
- people participating in an excessively heavy exercise program
- Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
See the full eligibility criteria
- NGT people will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG people
- Male or female people between the ages of 18 and 65 years of age, inclusive, at Screening.
- FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl
- BMI = 24-40 kg/m2;
- Stable body weight (±4lbs) over the preceding 3 months
- people 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...
- Oral contraceptive
- Injectable progesterone
- Subdermal implant
- Spermicidal foam/gel/film/cream/suppository
- Diaphragm with spermicide
- Copper or hormonal containing IUD
- Sterile male partner vasectomized \> 6 month pre-dosing.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- people must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.
- Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary...
- people with a family history of diabetes in a first degree relative
- BMI of less than 24 or greater than 40 kg/m2
- Unstable body weight (change of greater than ±4lbs over the preceding 3 months
- people participating in an excessively heavy exercise program
- Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
- people taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded.
- people with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
- Pregnant people or people unwilling to use birth control during their study enrollment
- Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the...
- people with hematuria will be excluded.
- people with evidence or prior history of heart failure will be excluded
- people with family history of pancreatic, bladder, and breast cancer will be excluded.
- people with history of pancreatitis will be excluded.
- people with eGFR \< 60 ±5 ml/min.1.73m2 will be excluded.
- people with elevated serum creatinine (\>1.5 mg/dl males/1.4 mg/dl females) will be excluded.
- people with a history of orthostatic hypotension (\>15/10 mmHg) will be excluded.
- people with liver enzymes (ALT, AST) \>3-fold above upper normal limit will be excluded.
- people with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.