Diabetes

Subcutaneous injection of 0.24 mg/kg Mozobil once at 8:30am

Mozobil

Policlinico Universitario, Azienda Ospedaliera di Padova

Stem Cell Mobilization With Plerixafor in Diabetic vs Control Subjects

Mobilization Test of BM Progenitor Cells With Plerixafor / AMD3100: Controlled Parallel Group Comparison Between Diabetic and Non Diabetic Subjects

To evaluate the differences of CD34+ cells mobilization from the bone marrow to the peripheral blood induced by a single sc injection of Mozobil in diabetic patients versus non diabetic controls.
Clinical response variable: comparison of the fold change in CD34+ peripheral cell count in diabetic versus non diabetic controls after Mozobil administration (with collection of safety and tolerability data).

to evaluate whether Mozobil monotherapy is able to induce a significant CD34+ stem cells mobilization in diabetic patients (intra-group comparison).
Clinical response variable: detection of a significant fold-change in CD34+ peripheral cell count versus baseline in diabetic patients.

To evaluate the differences in mobilization of EPC (CD34+KDR+) from the bone marrow to the peripheral blood induced by a single sc injection of Mozobil in diabetic patients versus non diabetic controls (inter-group comparison).
Clinical response variable: comparison of the fold change in CD34+ KDR+ peripheral cell count in diabetic versus non diabetic controls after Mozobil administration (with collection of safety and tolerability data).

To evaluate whether Mozobil monotherapy is able to induce a significant EPC mobilization in diabetic patients (intra-group comparison).
Clinical response variable: detection of a significant fold-change in CD34+KDR+ peripheral cell count versus baseline in diabetic patients

University of Padova

Azienda Ospedaliera di Padova

Eligible patients may enter the study at visit 1 according to the inclusion/exclusion criteria. At the screening visit, patients will enter a single blind placebo run-in period to establish baseline characteristics. Patients must have been stable on sulphonylurea therapy for at least 2 months prior to the screening visit to be included. For the duration of the run-in period, patients will receive BRL 49653C placebo in addition to their constant dose of sulphonylurea. Patients eligible to enter the double-blind phase of the study will be randomized in equal numbers at visit 2, to one of two treatment groups (BRL 49653C 2 mg bid. or placebo bid). Patients will then continue to take their study medication arid the constant dose of sulphonylurea through visits 3 to 8 (weeks 4 to 24).

Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy

BRL 49653C 2 mg bid or placebo bid through weeks 1 to 24.

BRL 49653C

Placebo

National Taiwan University Hospital

A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes

A Double-blind, Placebo Controlled, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of BRL 49653C With Concurrent Sulphonylurea Therapy, When Administered to Patients With Non-insulin Dependent Diabetes Mellitus.

Primary: Change from baseline for Hb A1c at week 24.
Secondary: Mean change from baseline for:
fasting plasma glucose,insulin levels, immune reactive,lipid levels (ie.total cholesterol, HDL-cholesterol, LDL cholesterol, triglycerides), body weight (WHR), vital signs (systolic, diastolic blood pressure and heart rate)

Physical examination, adverse experiences, laboratory safety data, ECG parameters

diabetes complications/galvos skausmas

Stem Cell Mobilization With Plerixafor in Diabetic vs Control Subjects

A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes

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