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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT01017302 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

Start date: December 2009
Phase: Phase 1
Study type: Interventional

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is <6 months. The target sample size is <100 patients.

NCT ID: NCT01014949 Completed - Diabetes Clinical Trials

Microcirculation Assessment in Diabetes and Metabolic Syndrome

MADAME
Start date: July 2008
Phase: N/A
Study type: Interventional

Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear. The aim of this study is to invasively assess coronary microcirculation and to investigate the relationship of insulin resistance with coronary microvascular dysfunction. A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a 5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR) will be calculated as the distal coronary pressure at maximal hyperemia divided by the inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA) index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood examinations before the procedure.

NCT ID: NCT01014832 Completed - Diabetes Clinical Trials

Efficacy and Safety of Frequently Modified Intensive Insulin

Start date: December 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of frequently modified intensive insulin therapy in patients with Type-2 and Type-1 diabetes mellitus.

NCT ID: NCT01013766 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1362885 in Type 2 Diabetics

Start date: August 13, 2009
Phase: Phase 1
Study type: Interventional

This study is the second administration of GSK1362885 in humans. GSK1362885 is a novel, potent inhibitor of human glycogen phosphorylase (GP) under development for the treatment of type 2 diabetes mellitus (T2DM). This study will investigate the compound's safety, tolerability, pharmacokinetics, and pharmacodynamics in subjects with Type 2 Diabetes Mellitus.

NCT ID: NCT01013571 Completed - Clinical trials for Diabetes Mellitus, Type 2

Self Titration With Apidra to Reach Target Study (START)

Start date: October 2009
Phase: Phase 4
Study type: Interventional

Primary Objective: The primary objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in Canadian patients with inadequately controlled T2DM after optimization of basal insulin, compared with an HCP-managed titration algorithm. The primary endpoint for assessment of this objective is the percent of patients reaching a target HbA1c <=7.0% without severe hypoglycemia at the end of the study. Secondary Objective: Secondary objectives of the study are to compare the effect of the two different insulin glulisine titration algorithms (patient-managed versus HCP-managed) on the following: - change in HbA1c, FG, and 7-point glucose profile at Week 24 and Week 36 - satisfaction with treatment (DTSQc for patient and questionnaire for HCP) at Week 36 - change in weight at Week 24 and Week 36 - incidence of hypoglycemia - insulin doses - resource utilization (rural/urban, blood glucose meter test strips, lancets, HCP visits, telephone calls, and hospitalizations) - adherence with the patient-managed monitoring algorithm

NCT ID: NCT01012037 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

NCT ID: NCT01011868 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

NCT ID: NCT01011387 Completed - Diabetes Clinical Trials

Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.

Start date: January 2010
Phase: N/A
Study type: Interventional

Primary objective - To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives - To investigate the pain level at dressing removal - To visually check exudate removal - To investigate the ease of use for the subject and care giver when using the NPWT system

NCT ID: NCT01010100 Completed - Diabetes Mellitus Clinical Trials

Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care

Start date: August 2000
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if the administration of small doses of Acarbose can prevent or delay the appearance of Type 2 Diabetes Mellitus in a population of subjects with prediabetes.

NCT ID: NCT01009580 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes

BOOSTâ„¢
Start date: November 5, 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.