View clinical trials related to Type 2 Diabetes Mellitus.
Filter by:Primary Objectives: To assess in overweight to obese T2DM patients: - The glucagon receptor occupancy of SAR425899 at two dose levels in the human liver with positron-emission tomography (PET) imaging using [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 as a tracer compound. - The GLP-1 receptor occupancy of SAR425899 at two dose levels in the human pancreas with PET imaging using [68Ga]Ga-DO3A-VS-Cys40-Exendin-4 as a tracer compound. - Pharmacodynamic effects on fasting plasma glucose and biomarkers of lipid metabolism. - Pharmacokinetic parameters for SAR425899 after repeated subcutaneous (SC) doses in plasma. - Safety and tolerability of SAR425899.
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus
It is submitted that incident and prevalent chronic periodontal infection, known as chronic periodontitis (CP) possibly has a causal relationship with diabetes mellitus (DM) having effects on HbA1c, fasting plasma/ blood glucose (FPG/ FBG) and fasting plasma insulin (FPI) levels. Experimental research has suggested that treating CP may improve glycemic control and insulin resistance in Non-Insulin Dependent Type-2 DM patients (T2DM). However, there is limited data concerning the need and effects of adjunct antibiotic therapy (AAT) along with scaling root planning (SRP) in treating CP for long lasting results. Therefore, it is suggested that further research with larger samples must be undertaken for a successful periodontal therapy that may help improve glycemic control at desired levels and longer durations. This study is designed to evaluate effects of periodontal therapy [SRP, metronidazole (MET) and oral hygiene instructions (OHI)] through three-arm trial experiment comprising of SRP+MET+OHI, SRP+OHI and OHI+ Delayed Therapy (DT) groups on HbA1c, FBG, FPI levels and Insulin Resistance calculated through Homeostasis Model Assessment (HOMA-IR) to fill research gap. This study will target large number of individuals (N > 1000) at trial camps known as diabetes-periodontitis (Diab-Per) camps at three different campuses of Dow University of Health Sciences hospitals to be screened for presence of signs and symptoms of chronic periodontitis and type-2 diabetes Mellitus. The selected candidates will be referred to the base camp for further evaluation to be enrolled in trial and recruit 150 participants randomly allocated in each group (50 in each group). Post-therapy follow-up results will be assessed at 1, 3 and 6 months to evaluate short and long term changes in status of CP, FBG, FPI and HbA1c.
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
Exercise is recommended for type 2 diabetes, which is a global health problem. However, during a moderate-intensity exercise training there is an unpredictable risk of hypoglycemia for patients with type 2 diabetes. Therefore, the investigators aim to explore trends in blood glucose levels in response to a 12-week moderate-intensity exercise training in patients with type 2 diabetes and to explore the predictors of post-exercise blood glucose (PEBG) and exercise-induced glucose response (EIGR). A descriptive and longitudinal design was conducted. Eligible type 2 diabetes patients were recruited from outpatient clinics of a medical center in Taiwan and invited to participate in a 12-week moderate-intensity exercise-training program. Each participant received 36 repeated measures of blood glucose during the exercise training program. Participants were randomly assigned to one of three exercise times (morning/afternoon/evening). Each exercise session was took place 1 to 2 hours after a meal. Capillary blood glucose levels were measured pre- and post-exercise. The EIGR was calculated from subtracting the PEBG from the before-exercise blood glucose (BEBG). Generalized estimating equation was used to examine the trends and predictors of PEBG and EIGR.
Aim: To implement a nutrition education programme (intervention) for adults with type 2 diabetes mellitus (T2DM) adapted from a primary health care setting to a tertiary hospital setting in South Africa and to evaluate the programme's effectiveness on dietary behaviours, clinical status and selected potential behaviour mediators. Participants and setting: T2DM adults (40-70 years) and at least one year of living with diabetes and poorly controlled diabetes (HbA1c ≥ 8%). The study setting is the outpatient clinic of a tertiary teaching hospital in Tshwane District (Pretoria), South Africa. Intervention: The intervention will employ a randomised control design with two parallel groups (intervention & control). A total sample of 140 T2DM patients (70 per group) will be needed to detect a 0.5 % change in HbA1c (SD of 1.0 and a power of 80%) at six month and allowing a 10% attrition rate. The intervention is one-year long with the following components: 7-monthly group education sessions; 2 bi-monthly group follow-up sessions at the hospital till one year; participants' workbook for goal setting activities and education materials (pamphlet and wall/fridge poster) for the intervention group. The control group will receive the same education materials with no other education encounters. Both groups will continue with usual care at the diabetes outpatient clinic of the hospital. The education will be offered face to face, will utilize teaching aids including coloured posters and will incorporate interactive group activities and demonstrations. The main facilitator is a qualified dietitian. Outcomes: Outcomes will be assessed at 6-and 12 months for both groups with the six month being the primary outcome. Outcomes will include clinical [HbA1c (primary outcome), BMI, blood pressure and full lipid profile); dietary behaviours (energy intake, starchy food servings, vegetable and fruits intake, macronutrient intake and their distribution to energy, fibre, meal pattern) and selected potential mediators of behavior (diabetes knowledge and diabetes management self- efficacy). It is hypothesized that the intervention will lower the HbA1c levels by at least 0.5% at six months and the levels will be significantly lower in the intervention group compared with the control group, and the significantly lower levels will be sustained at 12 months in the intervention group.
Primary Objective: To demonstrate the non-inferiority of Sotagliflozin 400 milligrams (mg) compared to Glimepiride on hemoglobin A1c (HbA1c) reduction at Week 52 in participants with Type 2 Diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in body weight, systolic blood pressure (SBP) in participants with baseline SBP ≥130 millimeter of mercury (mmHg), SBP in all participants, and proportion of participants with at least 1 documented symptomatic hypoglycemic event (≤70 milligrams per deciliter [mg/dL]). - To demonstrate the superiority of Sotagliflozin 400 mg compared to placebo on change in HbA1c, body weight, SBP in participants with baseline SBP ≥130 mmHg, SBP in all participants. - To demonstrate the superiority of Sotagliflozin 200 mg compared to placebo on change in HbA1c. - To demonstrate the non-inferiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. - To demonstrate the superiority of Sotagliflozin 400 mg compared to Glimepiride on change in HbA1c. - To evaluate the safety and tolerability of Sotagliflozin compared to Glimepiride and placebo.
The purpose of the present study is to determine if use of dietary supplement tauroursodeoxycholic acid enhances insulin-stimulated leg blood flow and glucose disposal.
The aim of the study is to assess the effectiveness of an intervention for insulin injection initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2 diabetes mellitus (T2DM).
The purposes of this study are to determine: - The safety of tirzepatide and any side effects that might be associated with it. - How much tirzepatide gets into the bloodstream and how long it takes the body to remove it. - How tirzepatide affects the levels of blood sugar. This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.