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Type 2 Diabetes Mellitus clinical trials

View clinical trials related to Type 2 Diabetes Mellitus.

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NCT ID: NCT03403582 Completed - Clinical trials for Type 2 Diabetes Mellitus

Raspberries and Postprandial Metabolism

Start date: December 2014
Phase: N/A
Study type: Interventional

Raspberries are high in several phytochemicals, vitamin C and B vitamins and have been shown to be potent antioxidants and anti-inflammatory agents. However, human interventional studies reporting the effects of raspberries in obesity, T2DM and associated oxidative stress and inflammation are limited. Aims, objectives and methods: Aim 1: To assess the effects of raspberries in postprandial glycemia and lipemia following a high-fat fast-food style meal challenge versus control group Objectives: to execute this aim, the investigators will conduct analyses of serum glucose, insulin and lipids (total cholesterol, LDL-cholesterol, triglycerides, VLDL-cholesterol and HDL-cholesterol) at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption. The investigators will also calculate homoeostasis model assessment of insulin resistance (HOMA-IR) at these time points using serum glucose and insulin values. Aim 2: To assess the effects of raspberries in postprandial vascular functions (blood pressure and artery elasticity) and inflammation following a high-fat fast food style meal challenge versus control group Objectives: to execute this aim, the investigators will measure C-reactive protein (CRP) and the following parameters of vascular function associated with CVD at fasting (baseline) and at postprandial 1,2,4 hours of high-fat, fast food style breakfast consumption: - systolic blood pressure and diastolic blood pressure - large artery elasticity index and small artery elasticity index - systemic vascular resistance

NCT ID: NCT03392961 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD

Start date: March 27, 2014
Phase: Phase 1
Study type: Interventional

A study to evaluate the PK and PD of oral IN-105 (Insulin Tregopil) w.r.t. time of dosing prior to meal, duration between meals and type of meal .

NCT ID: NCT03387787 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Evaluation of Glycaemic Control Using GlucoTab® With Insulin Degludec in Hospitalized Patients With Diabetes Mellitus Type 2

Start date: March 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process blood glucose data and physiological confounders of glycaemia. Subsequently, GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with visualization and documentation of relevant data. The GlucoTab® system was found capable to keep hospitalized diabetic patients in the recommended target range without increasing the risk for hypoglycaemic events. Insulin pharmacokinetic is a critical confounder of glycaemic variability and the main determinant of an algorithm-based decision support-system. GlucoTab® is intended for being used with a basal/bolus insulin regimen. Up to date, feasibility data are limited to the use of insulin glargine. Insulin degludec, an ultra-long acting basal insulin is characterized by a stable pharmacokinetic profile a half-life of ~25 hours. It was found equally effective to insulin glargine with respect to glycaemic control, while the incidence of (nocturnal) hypoglycaemia was smaller in patients treated with insulin degludec. Within the present study, insulin glargine will be replaced by insulin degludec, which is not yet approved for dose titration with GlucoTab®. In the present study, 15 non-critically ill T2DM patients, who were hospitalized at the University Clinic of Neurosurgery for various reasons and require insulin treatment will be recruited. Patients will be treated with insulin Tresiba and insulin Novorapid. For a maximum duration of 21 days, GlucoTab® will calculate the required insulin doses for each patient, depending on fasting plasma glucose and postprandial glucose measurements during the day. After the calculated Insulin dose has been approved by the physician, the nursing staff will give the dose to the respective patient. The present study will analyse the efficacy of GlucoTab® for glycaemic management in T2DM patients using insulin degludec.

NCT ID: NCT03387657 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

Start date: December 8, 2017
Phase: Phase 1
Study type: Interventional

Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: - To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ - To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ - To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide

NCT ID: NCT03386344 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Bone Safety of Sotagliflozin Dose 1 and Dose 2 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

SOTA-BONE
Start date: February 5, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to hemoglobin A1c (Hb1Ac) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise only or with a stable antidiabetes regimen. Secondary Objectives: - To compare the effects of sotagliflozin dose 1 and dose 2 versus placebo with respect to the percent change in bone mineral density (BMD) at lumbar spine, total hip, and femoral neck, measured by dual-energy X-ray absorptiometry (DXA). - To demonstrate the superiority of sotagliflozin dose 1 versus placebo on change in body weight (BW), fasting plasma glucose (FPG), systolic blood pressure (SBP) for all patients; and to evaluate the proportion of patients with a HbA1C <7%. - To demonstrate the superiority of sotagliflozin dose 2 versus placebo with respect to HbA1c reduction; change in BW, FPG, and SBP for all patients; and to evaluate the proportion of patients with HbA1c <7.0%. - To evaluate the safety of sotagliflozin dose 1 and dose 2 compared with placebo.

NCT ID: NCT03382015 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effect of BKR-013 on Average Daily Glucose Levels

Start date: January 8, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of BKR-013 on average daily glucose (ADG) levels in type 2 diabetes (T2D) subjects during 28 days of either placebo or active test product administration. Subjects will serve as their own controls in this crossover design, and ADG will be compared while a subject is on active test product versus while they received placebo test product.

NCT ID: NCT03380988 Completed - Clinical trials for Type 2 Diabetes Mellitus

Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease

Start date: November 2015
Phase: N/A
Study type: Interventional

The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.

NCT ID: NCT03380338 Completed - Clinical trials for Type 2 Diabetes Mellitus

The Effect of Exercise on Gut Microbiota in Type 2 Diabetic Patients

Start date: May 11, 2016
Phase: N/A
Study type: Interventional

To investigate whether targeted lifestyle intervention (exercise), induces a change in intestinal fecal microbiota related to improved glycemic control and systemic inflammation in patients with DM type 2.

NCT ID: NCT03377946 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effect of Probiotics on Pre-diabetes and Diabetes in China

Start date: December 21, 2017
Phase: N/A
Study type: Interventional

This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.

NCT ID: NCT03377335 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes

Start date: December 2017
Phase: Phase 4
Study type: Interventional

Dapagliflozin is a member of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class antidiabetes agents which produces significant and sustained reductions in glycemic parameters in patients with type 2 diabetes (T2DM). However, its non-glycemic effects are still largely unknown. The investigators will evaluate for the first time the effect of dapagliflozin on multiple cardio-metabolic risk markers in one study. So far, no data on the effects of dapagliflozin as well as other SGLT-2 inhibitors on subclinical atherosclerosis, endothelial function, inflammatory markers, cytokines and atherogenic lipoproteins is available. In addition, the investigators will examine microRNAs (miRNAs) implicated in the development and progression of atherosclerotic disease. Again, no data is currently available on dapaglifozin's as well as other SGLT-2 inhibitors' effects on miRNAs. The results of this study will show for the first time the potential multiple, non-glycemic effects of dapagliflozin, reducing multiple cardio-metabolic risk markers, which will ultimately lead to decreased CV risk. In addition, specific mechanisms of the dapagliflozin cardiovascular action will be investigated. Finally, the results of this study may pave the way for personalized therapy (using the results on miRNAs).