Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes

NCT02413398

Type 2 Diabetes Mellitus

COMPLETED PHASE3

Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)

NCT01165268

Type 2 Diabetes Mellitus

COMPLETED PHASE1

PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria

NCT03168295

Diabetes Mellitus, Type 2

COMPLETED PHASE4

Renal Impairment in Type 2 Diabetic Subjects

NCT00554450

Diabetes Mellitus, Type 2

COMPLETED PHASE1

Effect of SGLT2 Inhibitors on NAFLD in Type 2 Diabetic Patients with Diabetic Nephropathy

NCT06668753

Effect of SGLT2 Inhibitors NAFLD in Type 2 Diabetic Patients with Diabetic Nephropathy

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Researchers will measure the rate of hepatic and renal glucose production following dapagliflozin administration to determine the site of increase in EGP, liver versus kidney. Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals. Because the increase in EGP is associated with an increase in plasma glucagon concentration and renal glucose production is stated to be unresponsive to glucagon, the investigators anticipate that the liver will be responsible, in part, for the increase in EGP.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

T2DM individuals on Dapagliflozin

Individuals with type 2 diabetes mellitus - dapagliflozin

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

dapagliflozin, 10mg tablet

T2DM individuals on Placebo

Individuals with type 2 diabetes mellitus on placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for dapagliflozin

Normal Glucose Tolerance (NGT) on Dapagliflozin

Individuals with normal glucose tolerance - dapagliflozin

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

dapagliflozin, 10mg tablet

Normal Glucose Tolerance (NGT) Placebo

Individuals with normal glucose tolerance - on placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for dapagliflozin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapagliflozin

dapagliflozin, 10mg tablet

Intervention Type DRUG

Placebo

Placebo for dapagliflozin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Farxiga

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 25-35 kg/m\^2
* Normal Glucose Tolerance subjects (24)
* Type 2 Diabetic Subjects (24)
* Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
* Diabetic subjects must have HbA1c \<8.0%
* Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.
* Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

Exclusion Criteria

* Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.
* Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \>1.4 females or \>1.5 males, or 24-hour urine albumin excretion \> 300 mg will be excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes