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First of Three Phase 2 Combination Therapy Trials With DAC:GLP-1, Metformin Gets Underway
This three-month, placebo controlled, combination therapy study will provide data from no less than 72 evaluable patients in 17 centers across North America (10 in the U.S. and 7 in Canada). The patients will be randomized into three groups: Metformin plus placebo, Metformin plus a low dose of DAC(TM):GLP-1 (1 to 4 mcg/kg), and Metformin plus a high dose of DAC(TM):GLP-1 (2 to 8 mcg/kg). The primary end-point will be a comparison of HbA1C levels between the active treatment groups and the control group at the end of treatment. Results from this study are expected in the fourth quarter of calendar 2004.
After the initiation of this combination trial with Metformin, ConjuChem intends to conduct combination trials with both Sulfonylureas and thiazolidinedione (TZD), two other commonly prescribed anti-diabetic oral medications. These studies are planned to commence later in 2004. The aim of the trials is to determine the incremental benefits to be derived from combination therapy for Type 2 diabetic patients. A Phase II DAC(TM):GLP-1 monotherapy trial with 150 evaluable patients is currently ongoing with main results to be reported in July 2004.
GLP-1, the body's most potent insulinotropic hormone is a naturally occurring 36 amino acid peptide. GLP-1 has been shown to normalize blood glucose levels by a) stimulating insulin secretion and lowering glucagons secretion in a glucose-dependent manner; b) delaying gastric emptying; c) induces Beta cell proliferation; d) restores Beta cell sensitivity to glucose; and e) increases peripheral sensitivity to insulin (glycogen synthesis). Moreover, GLP-1 appears to have a very attractive safety profile, with a low probability of inducing hypoglycemia. However, the half-life of native GLP-1, without the benefit of DAC(TM) Technology, is only about 5 minutes, as it is simultaneously degraded by serum enzymes and cleared through renal excretion.
Source: ConjuChem Inc.