View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).
Background: - Bariatric surgery is the most effective way to achieve significant, long-term weight loss. It has also been shown to be an effective therapy for obese individuals with type 2 diabetes: more than 70 percent of patients no longer need medications for diabetes after surgery. This resolution of diabetes is predominately caused by marked weight loss resulting in improved insulin sensitivity. However, the beneficial effects of bariatric surgery on type 2 diabetes cannot be accounted for entirely by weight loss, because many bariatric surgery patients have resolution of diabetes within 1 week following bariatric surgery, even before they lose a clinically significant amount of weight. - One possible reason for the rapid resolution of diabetes after bariatric surgery .is that during the first week after surgery, patients can eat very little (about 300 Calories per day). It is well known that reducing calories to this level improves diabetes. Another possibility is that changes in the flow of food through the intestines may improve diabetes. Evidence for this comes from the observation that patients after gastric bypass have better glucose levels than those who have gastric banding. Researchers are interested in determining how much of the improvement in diabetes in the first week after Roux-en-Y gastric bypass (RYGBP) surgery is due to restricting calories, and how much is due to other factors, such as bypassing the upper part of the small intestine. Objectives: - To determine the change in total body insulin sensitivity after RYGBP compared to caloric restriction without surgery. - To study possible reasons for improvements in diabetes after RYGBP. Eligibility: - Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have type 2 diabetes. Design: - This is not a randomized study, and patients will not receive bariatric surgery as part of this study. Two groups of patients will be studied: those scheduled for RYGBP surgery and those not undergoing surgery. - RYGBP Surgery Participants: - Up to 3 weeks before surgery, participants will spend 2 nights and days at the Vanderbilt University Clinical Research Center or the NIH Clinical Center for testing to learn about how their bodies handle sugar and use energy. During the 5 days prior to these tests, participants will be asked to not take diabetes medications, and will check blood sugar at least twice a day. - From 8 days before surgery, participants will begin an 800 Calorie per day liquid diet to prepare for surgery. - After surgery and discharge, participants will be readmitted to the Clinical Research Center at Vanderbilt or NIH for further tests and diet monitoring. Diabetes medications may be adjusted or stopped altogether based on the results of the tests. - Non-surgery Participants: - Participants will spend 2 nights and days in the NIH Clinical Center for testing to learn about how their bodies handle sugar and use energy. During the 5 days prior to these tests, participants will be asked to not take diabetes medications, and will check blood sugar at least twice a day. - After the tests, participants will begin an 800 Calorie per day liquid diet for 8 days. - After 8 days, participants will be readmitted to the Clinical Center at NIH for 1 week of further tests and a 300 Calorie per day diet. Diabetes medications may be adjusted or stopped altogether based on the results of the tests.
Primary Objective: 1- Proportion of patients with mean daily glycemia <140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale. Secondary Objective: 1. Incidence of moderate hyperglycemia (>140mg/dL) during the treatment period. 2. Incidence of hypoglycemia (<60mg/dL and < 40mg/dL) during the treatment period. 3. Incidence of severe hyperglycemia (>400mg/dL) during the treatment period. 4. Total dose of insulin and correction dose in each group.
Randomized clinical trial (RCT) to compare treatment failure rates of surgical arthrodesis with MFB against cast treatment in patients suffering from early stage Charcot neuroarthropathy (CN) of the midfoot (Sella and Barrette stages 0, 1 or 2) within the first 2 years after initial treatment. Treatment failure is defined as the occurrence of one or more of the following: 1. Amputation, 2. Occurrence of ulcer or worsening of existing ulcer, 3. Surgical intervention for correction of deformity after initial treatment. The secondary aims are to compare foot function, radiologic outcome, quality of life, complications and foot temperature between the two groups.
Primary Objective: To demonstrate non-inferiority of once daily injection of insulin glargine (Lantus) plus one injection of mealtime insulin glulisine (Apidra) at the main meal versus twice daily premixed insulin (NovoMix 30/70) based on the reduction of HbA1c percentage from baseline to endpoint. Secondary Objective: - To determine treatment satisfaction (DTSQs/Diabetes Treatment Questionnaire - Status, DTSQc/ Diabetes Treatment Questionnaire - change and ITSQ/Insulin Treatment Satisfaction Questionnaire) - To determine the mean HbA1c, FBG (Fasting Blood Glucose), prandial BG (Blood Glucose) and proportion of patients with a HbA1c <7% - To determine the effect on adverse events (e.g. symptomatic hypoglycemic events, weight gain and injection site reactions) - To determine the total insulin dose, average insulin glargine, insulin glulisine and premixed insulin dosages.
This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone in patients with Type 2 Diabetes Mellitus.
The purpose of this study is to establish the usefulness and the impact of a tailored behavioral-education and counseling intervention titled Self-Management and Resourceful Transition (S.M.a.R.T) among patients with type 2 diabetes mellitus and stage 3 chronic kidney disease, in order to help them to manage their behaviors related to their condition and health.
This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.
The purpose of this study is to help answer the following research question(s): - To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks. - To evaluate the safety of LY2599506 in participants with diabetes. - To determine if LY2599506 has the ability to control blood sugar in participants with diabetes. - To determine how much LY2599506 should be given to participants. - To determine if LY2599506 has an effect on a participant's weight. The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow up period.
The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications specifically on the wide swings in blood glucoses with erratic control even under optimal conditions. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. Blood sugar diaries and laboratory tests including quarterly Hemoglobin A1c levels are monitored to measure progress and outcomes.