A new study evaluating the efficacy and safety of adding dapagliflozin therapy to the treatment of type 2 diabetes patients whose blood glucose levels remain poorly controlled despite high doses of insulin was published today in the Annuls of Internal Medicine. The 24 week study conducted on 808 type 2 diabetes patients with inadequately controlled blood sugar despite receiving insulin with or without pills by mouth found that patients who received dapagliflozin had better control of blood sugar and had more weight loss...

The FDA has issued a complete response letter regarding the New Drug Application (NDA) for investigational compound dapagliflozin for the treatment of type 2 diabetes in adults submitted by Bristol-Myers Squibb Company and AstraZeneca. The complete response letter issued by the FDA follows the recommendations of the The U.S. FDA Endocrinologic and Metabolic Drugs Advisory Committee which voted against the drug, in July 2011, saying that the efficacy and safety data do not provide substantial evidence to support approval of dapagliflozin...

The European Commission has approved Bristol-Myers Squibb Company and AstraZeneca’s ONGLYZA (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycemic) control in adult patients with type 2 diabetes. The approval was based on Phase 3b 24-week data submitted to the European Medicines Agency which showed that ONGLYZA 5 mg added to insulin (with or without metformin) significantly reduced blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult...

Results of an investigational Phase 3b clinical study, presented by Bristol-Myers Squibb Company and AstraZeneca at the 47th European Association for the Study of Diabetes (EASD), have shown that adding ONGLYZA (saxagliptin) 5 mg to ongoing insulin therapy (with or without metformin) maintained reductions of blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes. In the 52-week analysis, which is an extension of a 24-week trial presented at the 71st American Diabetes Association (ADA)...

The U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting reached a decision regarding the New Drug Application, by The  Bristol-Myers Squibb Company and AstraZeneca for the investigational compound dapagliflozin for treatment of type 2 diabetes. Dapagliflozin is being investigated as a monotherapy in addition to diet and exercise, and in combination with other anti-diabetic agents in addition to diet and exercise, to evaluate its effect on blood sugar levels (or HbA1c)...

The European Commission approved a label update for ONGLYZA® (saxagliptin) in the treatment of adults with type 2 diabetes who have moderate or severe renal impairment following results of a new study submitted by AstraZeneca and Bristol-Myers Squibb Company. The approved dosage for the patient group is a new once-daily 2.5 mg dose. ONGLYZA will be the first dipeptidyl peptidase-4 (DPP-4) inhibitor in Europe available for type 2 diabetes patients with moderate or severe renal impairment. ONGLYZA is indicated in adult patients...

Bristol-Myers Squibb Company and AstraZeneca announced that type 2 diabetes drug Kombiglyze XR (saxagliptin and metformin HCl extended-release), approved by the FDA on November 5, 2010, is now available by prescription in pharmacies across the United States. Kombiglyze XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic control across hemoglobin A1c levels, fasting plasma...

Bristol-Myers Squibb Company and AstraZeneca announced FDA approval of KOMBIGLYZE™ XR, the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet for the treatment of type 2 diabetes in adults. KOMBIGLYZE XR offers strong glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG). KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve ...

Bristol-Myers Squibb Company  and AstraZeneca announced results from a randomized, double blind Phase 3 clinical study, which demonstrated that the addition of the investigational drug dapagliflozin to existing glimepiride (sulphonylurea) therapy produced significant reductions in HbA1c in adult patients with type 2 diabetes compared to glimepiride alone. The study also demonstrated that dapagliflozin plus glimepiride achieved reductions in the secondary efficacy endpoints of change...

Bristol-Myers announced that findings from a 24-week Phase 3 clinical study, published online in the latest issue of Diabetes Care, demonstrated that the investigational drug dapagliflozin, administered as a monotherapy, achieved statistically significant mean reductions at 5 mg and 10 mg doses once daily in the primary endpoint of HbA1c levels in treatment-naïve adult patients with newly diagnosed type 2 diabetes. The study also showed reductions in the secondary endpoint of fasting plasma glucose (FPG) and total body weight...