Active clinical trials for "Diabetes Mellitus, Type 2"

Aim: To investigate the therapeutic potential of IL-1Ra in type 2 diabetes. Rationale: Since the major defect leading to a decrease in b-cell mass in type 2 diabetes is increased apoptosis, therapeutic approaches designed to arrest apoptosis could be a significant new development in its management. This approach might actually reverse the disease to a degree rather than just palliate glycemia. Based on current thinking, treatment with IL-1Ra appears as a promising approach. The prospected effect is blocking of the IL-1b-mediated glucotoxicity and thereby to prevent the decline in b-cell mass, together with a rapid restoration of b-cell function. FDA approval for IL-1Ra in the treatment of rheumatoid arthritis occurred based on a favourable tolerability profile.

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

To determine, in subjects with Type 2 Diabetes Mellitus: Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.

Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.

The purpose of the ROSITEL study is to assess the effects of rosiglitazone, as compared to standard oral therapies for diabetes (metformin/sulfonylurea), on inflammatory markers and adipokine levels in diabetic patients using an angiotensin receptor blocker (ARB). We hypothesize that ARB-treated diabetic patients receiving rosiglitazone will experience greater reductions in vascular inflammation and levels of leptin and resistin, associated with increased adiponectin levels, compared to a metformin/sulfonylurea regimen, and that these benefits will result in part, from greater improvements in insulin sensitivity in the rosiglitazone group.

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).

In the present study, endothelium dependent vasodilation will be induced by administration of acetylcholine (ACh). To ascertain whether the vascular effects, if any, of α-lipoic acid are limited to the endothelium, endothelium independent vasodilation will also be assessed by administration of glyceroltrinitrate (GTN). Study objectives To investigate the effect of α-lipoic acid therapy on endothelium dependent and independent vasodilation, assessed by forearm blood flow (FBF), in patients with type 2 diabetes mellitus Study design Randomized, double-blinded, parallel group study for 23 days: Day 1: FBF responses to acetylcholine and glyceroltrinitrate Day 2-22: intravenous infusion of 600 mg α-lipoic acid or placebo Day 23: FBF responses to acetylcholine and glyceroltrinitrate Study population 30 subjects with type 2 diabetes Study medication Acetylcholine (ACh) - intraarterial infusion, 25, 50, 100 nmol/min, infusion period 3 minutes/dose level Glyceroltrinitrate (GTN) - intraarterial infusion, 4, 8, 16 nmol/min, infusion period 3 minutes/dose level α-lipoic acid - intravenous infusion of 600 mg in 250 ml saline solution over 30 minutes Main outcome variables Forearm blood flow (Ratio between intervention and control arm) Additional outcome variables Arterial blood pressure, pulse rate, markers of inflammation and oxidative stress, Insulin plasma levels, Glucose plasma levels Risk/benefit assessment The insertion of intravenous cannula may cause mild and transient pain. A minor hematoma may occur at the site of cannula insertion. The insertion of the intraarterial cannula is performed under local anaesthesia and causes mild pain. The meassurement of forearm bloodflow, espacialy the wrist cuff (>200 mmHG) may be uncomfortably. Local administration of drugs through a needle in the brachial artery allows the study of direct vascular effects of the drugs. Drug doses are 100 to 1000 times lower than a systemic effective dose, therefore no systemic adverse events are expected. There is experience in brachial artery infusions at our institution, and it is considered a safe technique. α-lipoic acid was well tolerated in healthy volunteers and subjects with diabetes at doses up to 600 mg intravenously and 1800 mg orally with side effects comparable with placebo. Altogether 50 ml blood will be collected throughout the study.

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology.

This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes Mellitus and Metabolic Syndrome. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).