Active clinical trials for "Diabetes Mellitus, Type 2"

An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in Type 2 Diabetes Mellitus (T2DM) Patients

The overall objective of this study is to construct an adaptive intervention that integrates family members and patients as partners in care while promoting diabetes self-management for Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based, culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to help determine what sequence of intervention strategies work most efficiently and for whom.

This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.

Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin. Secondary Objectives: To compare Sotagliflozin 400 mg versus placebo based on: Change from baseline in fasting plasma glucose (FPG). Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mm Hg). Change from baseline in SBP for all participants. Change from baseline in body weight. Percentage of participants with HbA1c <6.5% and <7.0%. To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Further studies are needed to establish the optimal diet for treating T2D. The investigators wishes to investigate whether a low carbohydrate diet, high in monounsaturated fats (LCD) will affect cardiovascular function, metabolism and the liver. 135 participants with T2D, will be following either a LCD, or a regular diabetes diet (RDD) for 6 months. Measurements and investigations will be performed at baseline and after 6 months.

This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.

Patients with type 2 diabetes (T2 DM) have a markedly increased risk of heart disease and it is estimated that, in the danish population, up 80% percent of patients with type 2 diabetes die from heart disease. The sodium glucose cotransport-2 (SGLT-2) inhibitors were developed as an anti-diabetic therapy reducing blood glucose and weight by decreasing glucose reabsorption in the kidneys, leading to glucose excretion via the urine. However, in 2015 the EMPA-REG study showed that treatment with the SGLT-2 inhibitor empagliflozin significantly reduced the cardiovascular mortality and risk of admission under the diagnosis of heart failure in a population of patients with type 2 diabetes in addition to other risk factors for heart disease. The mechanism behind this surprising result is unknown and warrants further study. The primary hypothesis of the present study is that treatment with empagliflozin improves the function and blood supply of the heart muscle cells in patients with type 2 diabetes and high risk of heart disease. The investigators will test this hypothesis by enrolling 92 participants with type 2 diabetes and other risk factors for heart disease, and treating them with either empagliflozin or a placebo. During the study period the investigators will monitor the effects of the treatment with various techniques such as heart scans using CT and ultrasound, measurements of the fluid pressures in the heart chambers, body composition measurements and a variety of relevant blood test.

A Study to Assess the Fed-state Bioequivalence of a Triple Fixed-Combination Drug Product (FCDP) of 2.5 mg Saxagliptin / 5 mg Dapagliflozin / 1000 mg Metformin XR and 5 mg Saxagliptin /10 mg Dapagliflozin /1000 mg Metformin XR Relative to Individual Components (Onglyza and XIGDUO XR) Co-administration. A randomized, open-label, cross over design has been chosen to minimize the effects of between-subject variability and any period effects on the overall results.

This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the inclusion criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Major enrollment criteria include: (1)Subjects have confirmed type 2 diabetes and fail to reach the treatment goal (fasting glucose 140-270mg/dL and hemoglobin A1c (HbA1c) 7-10%) after stable use of 1-3 oral hypoglycemic drugs for 3 months; (2)Subjects have stable diabetes mellitus (DM) history with fasting glucose 140-270mg/dL and HbA1c 7-10% and refuse to use oral medications. Efficacy outcomes include the changes in fasting glucose, Hb1Ac, and insulin sensitivity, and safety assessments include liver and kidney function, and complains made by subjects after the initiation of the investigational products (IP).

The purpose of this study is to examine the drug-drug interaction when given the study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1 receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when administered with exenatide injection.