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SGLT2i, Pioglitazone, and Ketone Production in T2D

Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 weeks
  • Procedures mentioned: Infusions, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study Design: Infusions of 3-3H-glucose and 14C-glycerol are started and continued to study end (2 PM)."
  • "Baseline blood samples for HbA1c (x2) and for plasma insulin, glucagon, glucose, FFA, BHB, AcAc, glycerol, and plasma 3-3H-glucose and 14C-glycerol specific activities are drawn at -30, -20, -10, -5, and 0 minutes for measurement of lipolysis, ketone production (plasma ketone levels), and EGP."
  • "Following completion of the above study, subjects will be randomized to one of four groups (16 per group) for 10 weeks: (1) empagliflozin, 25 mg/day, plus pioglitazone placebo; (2) pioglitazone, 15 mg/day, increased to 30 mg after 2 weeks plus empagliflozin placebo; (3) empagliflozin (25 mg/d) plus pioglitazone (15/30 mg/d); (4) empa placebo plus pio placebo."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with type 2 diabetes. It tests whether pioglitazone can block the rise in the body's sugar production, fat breakdown, and ketone production caused by empagliflozin. Ketones are chemicals made when the body breaks down fat.

To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 30–75, with a BMI of 21–45. BMI is a measure of weight compared with height.
  • HbA1c of 7%–11%. This blood test measures average blood sugar over the past few months.
  • Kidney filtering test (eGFR) above 60 and blood pressure no higher than 160/90.
  • In good general health based on health history, an exam, blood and urine tests, and a heart rhythm test.
  • Weight has changed no more than 1.5 kg over the past 3 months, and no very heavy exercise program.
  • Diabetes treated with diet, sulfonylurea medicines, metformin, or both medicines.
  • If taking a GLP-1 diabetes medicine, the dose must be unchanged for at least 3 months. If taking a DPP-4 diabetes medicine, the dose must be unchanged for at least 2 months.
  • SGLT2 diabetes medicines must be stopped for at least 2 months before screening. Statins, which lower cholesterol, are allowed if the dose has been unchanged for at least 3 months.

Who can't join

  • Taking insulin or diabetes medicines called thiazolidinediones (TZDs).
  • Taking other medicines that affect blood sugar, apart from the allowed diabetes medicines.
  • Taking an SGLT2 diabetes medicine within 2 months of screening. People taking one during prescreening may be asked to stop it for 2 months and have blood sugar checks to see if they can qualify.
  • Having proliferative retinopathy, an eye disease with abnormal blood vessel growth.
  • Having a kidney filtering test (eGFR) below 60.
  • Being able to become pregnant and not using suitable birth control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Ages 30-75 * BMI (Body Mass Index) 21-45 kg/m2 * HbA1c = 7.0-11% * eGFR (estimated glomerular filtration rate)\> 60 ml/min/1.73m2 * Blood Pressure (BP)≤160/90 mmHg * Participants must be in general good health based on medical history, physical exam, screening blood chemistries, CBC (Complete Blood Count), TSH/T4 (thyroid/thyroxine hormone), EKG (electrocardiogram), and urinalysis (UA) * Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program * Patients treated with diet, Sulfonylureas, Metformin, or Sulfonylureas/Metformin (Sulfo/MET) * Participants receiving a Glucagon like peptide -1 receptor agonist (GLP1-RA) must be on a stable dose for at least three months prior to study enrollment. * Participants receiving a Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitor) must be on a stable dose for at least two months prior to study enrollment. * SGLT2 inhibitors must be discontinued at least two months prior to study enrollment. * Statin therapy is permissible if the dose has been stable for at least 3 months EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: * Patients treated with Thiazolidinediones (TZDs), or Insulin are excluded. * Patients taking medications other than Sulfonylureas/Metformin (SU/MET), stable dose of GLP1-RA and DPP4i known to affect glucose metabolism are excluded. Patients taking SGLT2i within 2 months of screening visit will be excluded from participating in this study, however they may be asked whether they would agree to discontinue the medication for two months to become eligible. (Please see clarification below.) \* * Subjects with evidence of proliferative retinopathy or estimated glomerular filtration rate (eGFR) \< 60 are excluded * Women of childbearing potential are excluded unless they are taking/using appropriate contractive medications/devices \* Only participants who are taking SGLT2 inhibitors during the prescreening period will be asked to discontinue the medication at least two months prior to the screening visit. If they agree, they will return for an HbA1c measurement four weeks after stopping the SGLT2 inhibitor. If their HbA1c rises to greater than 10%, treatment will be initiated with either metformin, a DPP-4 inhibitor, or a sulfonylurea. We do not anticipate any adverse effects during this initial period, provided the HbA1c remains below 10%. HbA1c will be measured using a fingerstick test, which requires only a minimal amount of blood. No compensation will be provided during this phase. After two months of medication discontinuation, participants will return for a screening visit. If they meet all eligibility criteria, they will be enrolled in the study and payment done by protocol.

Study sites (1)

TX