Related Experiment Video
Updated: May 8, 2026
00:04
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
10.6K
Multicenter, open label, randomized controlled superiority trial for availability to reduce nocturnal urination
Hanako Nakajima1, Hiroshi Okada1,2, Akinori Kogure3
1Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Journal of Diabetes Investigation
|September 18, 2024
Summary
Sodium glucose co-transporter 2 inhibitors (SGLT2i) like tofogliflozin did not worsen nocturia in type 2 diabetes patients. Combining tofogliflozin with salt restriction significantly reduced nocturia frequency.
Area of Science:
- Endocrinology
- Nephrology
- Metabolic Diseases
Background:
- Nocturia significantly impacts the quality of life for individuals with type 2 diabetes mellitus.
- Sodium glucose co-transporter 2 inhibitors (SGLT2i) are known to increase urine volume, but their specific effect on nocturia, especially when combined with dietary interventions, requires further investigation.
Purpose of the Study:
- To evaluate the efficacy of tofogliflozin, a short half-life SGLT2i, in managing nocturia in patients with type 2 diabetes.
- To determine if combining tofogliflozin with dietary salt restriction enhances its effect on nocturia compared to tofogliflozin alone.
Main Methods:
- A multicenter, open-label, randomized, parallel-group trial involving 80 patients with type 2 diabetes and nocturia.
- Participants were assigned to receive either tofogliflozin alone or tofogliflozin combined with dietary salt restriction for 12 weeks.
- Primary endpoint was the change in nocturia frequency; secondary outcomes included daytime urination frequency, urine volume, and home blood pressure.
Main Results:
- No significant difference in nocturia frequency was observed between the tofogliflozin-only group and the combination group at 12 weeks.
- However, the group receiving both tofogliflozin and salt restriction showed a statistically significant decrease in nocturia frequency (P=0.049).
- A trend towards increased daytime urine volume and frequency was noted in the salt restriction group, suggesting a time-shift effect.
Conclusions:
- Tofogliflozin treatment did not lead to an increase in nocturia frequency.
- Combining tofogliflozin with dietary salt restriction demonstrated a significant reduction in nocturia.
- The findings suggest that dietary modifications, such as salt restriction, can augment the benefits of tofogliflozin in treating nocturia in type 2 diabetes patients, potentially by shifting urine production to daytime hours.
Related Concept Videos
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:11Bioavailability Study Design: Single Versus Multiple Dose Studies
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
01:30Urinary Tract Infection III: Diagnostic Studies and Interprofessional Care
A healthcare provider can diagnose a urinary tract infection (UTI) through several methods:Medical History and Symptoms: The provider will take a detailed medical history and ask about symptoms such as frequent urination, burning sensation during urination, and lower abdominal pain.Urinalysis: A clean-catch urine sample is collected in a sterile container and tested for the presence of bacteria, white blood cells (leukocytes), nitrites, blood, and protein. The presence of leukocytes and...
01:19Urodynamic Studies: Uroflowmetry
Uroflowmetry is a non-invasive urodynamic test designed to measure various aspects of urination, including volume, flow rate, and the time to void. This test is crucial for diagnosing and assessing conditions such as bladder outlet obstruction, bladder dysfunction, incomplete bladder emptying, incontinence, and urinary tract blockages caused by benign prostatic hyperplasia (BPH) and urethral strictures.Pre-Test Instructions:Before a uroflowmetry test, patients are typically advised to drink...
01:26Urine Studies II: Urine Culture and Sensitivity Test
A urine culture and sensitivity test is a diagnostic procedure used to identify urinary tract bacterial infections and determine the most effective antibiotics for treatment. This test is generally preferred when a patient shows manifestations of a urinary tract infection, such as frequent or painful urination, cloudy or foul-smelling urine, or lower abdominal pain.Purpose of the TestThe primary goals of a urine culture and sensitivity test are to:Determine the specific bacteria causing the...