View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).
To assess the safety and efficacy of Exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.
The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 36 weeks in obese type 2 diabetic patients inadequately controlled with diet and exercise alone. The secondary objectives are: - To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters; - To evaluate the safety and tolerability of Rimonabant compared to placebo; - To evaluate the pharmacokinetics of Rimonabant.
The primary objective of this study is to assess the efficacy of SR141716 (rimonabant) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor). The secondary objectives are: - To evaluate the effect of SR141716 compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters - To evaluate the safety and tolerability of SR141716 compared to placebo - To evaluate the pharmacokinetics of SR141716
This trial is conducted in Europe, Asia and South America. A one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (COPD).
This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
At least 20% of patients hospitalized in the general medical and surgical wards at any given time suffer from diabetes. It has been demonstrated that poor clinical outcome correlates with the degree of hyperglycemia in these patients. Strict glucose control in hospitalized patients improves clinical outcomes in the setting of acute myocardial infarction, cardiac surgical procedures, infection and critical illness in patients hospitalized in intensive care units if insulin is applied intravenously. It is, however, complex to obtain strict glucose control in the general surgical and medical wards. These wards are usually understaffed as compared to intensive care units and therefore are incapable to perform the necessary close monitoring essential in patients treated with intravenous insulin. We intend to test the feasibility of glucose control by multiple daily subcutaneous injections with long acting basal glargine insulin and pre-meal insulin analogues. If good glucose control can be achieved, this would be a valid, more convenient and acceptable alternative to intravenous insulin infusions to obtain good glucose control in diabetic patients hospitalized in general internal medicine wards.
Primary objective: - To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period. Secondary objectives: - Percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo. - To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on: - Weight and waist circumference. - Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c. - Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B. - Inflammatory markers - Adipocytokines. - Blood pressure. - Glomerular filtration rate. - To assess the quality of life by means of questionnaire filled in. - Safety parameters
Background. Antihypertensive therapy with ß-blockers (ßBs) and diureticts (Ds) is accompanied by a higher incidence of diabetes mellitus (DM) than therapy with ACE-inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs). Whether this difference is due to an antidiabetogenic action of ACEIs and ARBs or to the fact that these agents are free of the diabetogenic activity of ßBs and Ds is unknown. Prevention of DM as well as of HT is of primary health concern. Objectives. The primary objective of PHIDIAS is to test whether in individuals with components of metabolic syndrome making them predisposed to DM and HT, addition of either an ACEI or an ARB to periodically reinforced lifestyle counselling can reduce 1) onset of DM and 2) onset of HT significantly more than lifestyle plus placebo. Secondary objectives are 1) comparing the antidiabetogenic effects of ACEI and ARB, and 2) investigating whether the effects of ACEI and ARB on DM and HT persist at least 6 months after treatment withdrawal. Methods. PHIDIAS is a prospective, double-blind, placebo-controlled 3-arm comparison trial. 300 general practitioners (members of SIMG with the assistance of hospital centres of SIIA) will randomise 6000 untreated individuals aged 40-75 years, with SBP 130-139 or DBP 85-89 mmHg, fasting glucose (FG) 100-125 mg/dl, waist circumference >= 102 (M) or >= 88 cm (W), to three blinded treatments, given in addition to lifestyle advise: 1) Placebo; 2) the ACE Enalapril (10 mg, then 20 mg od); 3) the ARB Losartan (50 mg, then 100 mg od).Double-blind treatment will be maintained until 500 cases of DM are observed (presumably average of 36 months) (Treatment Phase: control visits, BP, FG every 6 months). This will be followed by a 6-month Withdrawal Phase (active treatment substituted by placebo). Primary outcomes are DM (FG >= 126 mg/dl) and HT (SBP >= 140 or DBP >= 90 mmHg) on 2 consecutive visits. PHIDIAS will be governed by a Steering Committee assisted by a blinded Event Adjudicating Committee and an independent DMSB. Expected results. The sample size is adequate (alfa 5%, power 90%) to evaluate whether incident DM (expected rate 3.5%/year) or incident HT is reduced 25% by ACEI and ARB versus placebo (primary hypothesis) and whether either the ACEI or the ARB reduces incident DM by 30% more than the other agent.
The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.