Active clinical trials for "Diabetes Mellitus, Type 2"

The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.

This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).

This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.

Insulin resistance is a central feature of Diabetes mellitus type 2 (Stumvoll et al. 2005). Hypo- and hyperglycemic states are associated with adverse inpatient outcomes (ADA et al. 2006 Diab Care) and with the development of microvascular complications (UKPDS 34 Lancet 1998). A long known therapy for the acute treatment of patients with deteriorated glucose metabolism and insulin resistance are carbohydrate days. The principle of the therapy was firstly introduced in 1903 by Carl von Noorden (Noorden et al. 1903). The diabetic patients were treated for several days with a carbohydrate rich diet with fat restriction. Surprisingly, this resulted in an amelioration of glucosuria. Today it's still a valuable tool for patients with uncontrollable diabetes mellitus and severe insulin resistance (Willms B. 1989). But up to now there has been no systemic evaluation of carbohydrate days in patients with deteriorated Diabetes mellitus and insulin resistance. The investigators conducted a pilot study with 14 patients to evaluate the efficacy of two days of oatmeal on insulin resistance and glucose metabolism in an acute clinical setting and after a four week outpatient period. Inclusion criteria were type 2 diabetes with deteriorated glucose metabolism, insulin resistance defined as an insulin dosage of more than 1 U per day and kg bodyweight. Within this pilot trial the investigators found a marked decrease of insulin requirements (~40%) and mean daily blood glucose to a mean blood glucose of 114.7±36.7 mg/dl in the acute setting as well as after the four week outpatient period (Lammert et al. 2006). The most important shortcomings of this study were the hypocaloric interventions in both groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to attribute the observed effects to oatmeal alone as well as the uncontrolled nature. These design flaws have been addressed within this new clinical trial. The investigators plan an open label, cross-over study with isocaloric interventions (oatmeal and diabetes-adapted diet: ~ 1200kcal/d). The intervention comprises two days of oatmeal (third and fourth day) within a 5 day hospital stay. The control is only treated with 5 days of diabetes adapted diet. Thereafter, the patients are followed every four weeks for an overall of 16 weeks.

This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups: Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day. Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

The aim of this study is to find out whether the hypoglycemic and improving insulin resistance effect will appear or not, when EA applying on specific acupoints of NIDDM patients.

Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.

The overarching objective of this study is to develop an innovative strategy to address the problems of obesity and diabetes by promoting exercise adoption. An automated telephone intervention will be developed that can be used to enhance exercise adoption over a twelve month period in a population of overweight or obese veterans with Type 2 diabetes.

A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.