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Last Updated: 09/18/2022

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A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MN-001 in Patients Diagnosed With Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia

Summary: The design of the Phase 2 clinical trial includes the following elements:~Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S.~Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks.~The co-primary endpoints are (1) change from baseline in l...

i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management

Summary: This study will integrate a technology-based patient-reported outcome (PRO) system [herein MJS DIABETES] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platform that utilizes text-messaging to capture patients' self-reported PROs in real-time; enhance patient...

A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants

Summary: In this study, four new tablet versions of two compounds will be investigated.~The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.~Participants will receive one treatment ...

Healthy Hearts: Leveraging the Diabetes Prevention Program to Decrease Health Disparities in Women of Reproductive Age

Summary: Nearly half of women have obesity and/or hypertension (HTN). Specific to women, pregnancy creates a vulnerable window for excess gestational weight gain (GWG), exacerbating intergenerational risks for obesity, HTN, type 2 diabetes (T2D), and cardiovascular disease (CVD) across the lifespan. Healthy lifestyles are the first-line recommendations for prevention and treatment of overweight/obesity, HT...

An Adolescent-mediated Intervention to Improve Diabetes Prevention and Management in Pacific Islander Families

Summary: The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of an adolescent-mediated intervention designed to improve the glycemic control and self-care practices of a parent/grandparent. The preliminary impact of the intervention on adult glycemic control (HbA1c) and self-care behaviors, as well as adolescent risk factors, will be explored with the goal of inform...

The Effect of a Ketone Drink on Liver Glucose Production in People With Type 2 Diabetes

Summary: What is the effect of a ketone drink on liver glucose production, and postprandial glycemia, in people with type 2 diabetes.

Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study

Summary: This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide [2 milligrams (mg), 8 mg, or 16 mg] or semaglutid...

Evaluation of an EMR-Based Clinical Decision Support Tool for the Implementation of Guideline-Directed Therapies for Prevention of Heart Failure Among High-Risk Patients With Type 2 Diabetes

Summary: Type 2 diabetes mellitus (T2DM) is an independent risk factor for heart failure (HF) and is associated with significant morbidity and mortality. Recent therapeutic advances in pharmacotherapies, such as sodium-glucose cotransporter-2 inhibitors (SGLT2i), have shown to be beneficial in preventing HF among patients with T2DM. However, despite widely available risk prediction and stratification tools...

A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

Summary: The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.

Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT

Summary: Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. Moreover, the investigators pl...

Effect of Serum LDL Cholesterol Concentration on Pancreatic Insulin Secretion

Summary: Dyslipidemia is characterized by low levels of HDLs, hypertriglyceridemia as well as an increases proportion of small dense LDLs. Changes in lipoprotein particles and its concentrations, especially increased levels of pro-atherogenic LDL particles play an important role in the development of cardiovascular diseases. It is well established that statin/PCSK9-inhibitor treatment is very effective in ...

Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes

Summary: The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will ...
Showing 1-12 of 1,107

Last Updated: 09/18/2022