mellitus in Medical Technology

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

... in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. AFRESA is ... period in subjects with type 1 and 2 diabetes mellitus receiving AFRESA (n=730) or usual antidiabetic ... in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. It is a ...

Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clinical Trials

... treatment for patients with type 2 diabetes mellitus no longer controlled on oral antidiabetic ... Body Weight in Subjects with Type 2 Diabetes mellitus (T2DM) Treated with Metformin: A ... taspoglutide in patients with Type 2 diabetes mellitus inadequately controlled with metformin -- ...

DiObex, Inc. Awarded Patent for the Prevention of Insulin-Induced Hypoglycemia

... insulin-induced hypoglycemia in type 1 diabetes mellitus in an extended release subcutaneous formulation ... inhibitor in development for type 2 diabetes mellitus and diabetic nephropathy. Abnormalities in ... place people at high risk for type 2 diabetes mellitus and cardiovascular disease. For more ...

MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus

... (search for Protege) diabetes mellitus (less than or equal to 12 ... onset type 1 diabetes mellitus (less than or equal to 6 weeks ... ages 8-30 with type 1 diabetes mellitus within 4-12 months of ...

Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients

... AFRESA Inhaler for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. AFRESA is conveniently administered by ... being studied for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. It is a drug-device combination ...

Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability

... matrix, today announced new Phase I data for the company's diabetes mellitus program at the American Diabetes Association's 68th Scientific Sessions. ... more like that of natural, endogenous prandial insulin release. Diabetes mellitus is an increasingly prevalent, costly condition associated with substantial ...

New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes

... for the treatment of adults and children with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of ...

Synvista Collaboration Demonstrates in Preclinical Studies the Mechanism for Defective Cholesterol Transport in Patients with Diabetes

... a defect in reverse cholesterol transport in patients with Diabetes mellitus (DM). The studies reveal that a common blood protein, Haptoglobin, binds ... in reverse cholesterol transport observed in many patients with diabetes mellitus (DM). Reverse cholesterol transport describes the process of moving ...

Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)

... in December 2007. On March 6, 2009 the FDA informed Takeda that based on the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the amount of existing alogliptin clinical data in the ...

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes

... Takeda that, although the alogliptin NDA was filed prior to the release of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," the FDA did not believe that the amount of existing ...

Spherix Announces Positive Phase 2 Study Results

... Anti-Diabetic and Obesity-Control Drug. Diabetes, Obesity and Metabolism . 10 , 2008, 109-134.) About Type 2 Diabetes Type 2 diabetes mellitus (T2DM) is a disease that is characterized by elevated blood glucose in the context of insulin resistance and comparative insulin deficiency. While ...

SCAI Statement on the BARI 2D Trial (Bypass Angioplasty Revascularization Investigation With Diabetes Trial) Presented at the American Diabetes Association (ADA) Annual Scientific Sessions and Published in The New England Journal of Medicine

... screened for CAD. Many diabetic patients may not exhibit symptoms such as chest pain or shortness of breath; however, patients with type 2 diabetes mellitus and CAD are at high risk for cardiovascular events, including heart attack. According to the American Diabetes Association, diabetes affects nearly ...

Long Term Data Presented at EuroPCR 2009 from Randomized Study Attest to Durability of Results of OrbusNeich's Genous(TM) Bio-engineered R stent(TM) Compared to Drug-Eluting Stents

... single-center, prospective study involving patients with a high risk of restenosis. High risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than or equal to 2.8 mm) and/or long lesions (greater than or equal to 23 mm) and/or chronic total occlusions. Two year ...

Arcion Therapeutics' Topical Pain Candidate, ARC-4558, Significantly Reduces Pain Caused by Diabetic Neuropathy

... throughout the study. About Painful Diabetic Neuropathy (PDN) Diabetic neuropathy is one of the most common complications of diabetes mellitus that is associated with a number of painful conditions. According to 2008 estimates by the Centers for Disease Control and Prevention, nearly 24 ...

InteKrin Therapeutics Announces Enrollment Completion of 360 Patient, 24 week Phase 2b Study

... Phase 2a study and demonstrate the unique properties of INT131, a potent insulin sensitizer, in patients with inadequately controlled type 2 diabetes mellitus (T2DM), said Alex DePaoli, M.D. InteKrin's Chief Medical Officer. "This Phase 2b study will provide critical efficacy, safety, and tolerability data ...

Diabetes Patients with High Triglycerides and Low HDL Cholesterol Get the Most Benefit From Fenofibrate Treatment: New Data From the FIELD Study

... Lancet 2007;370:1687-97. 7. Colman P, Rajamani K, Li L-P et al. Benefits of long-term fenofibrate therapy on amputations in type 2 diabetes mellitus in the FIELD trial. Presented at the European Association for the study of Diabetes (EASD), Rome, September 2008. 8.Efficacy of ...

Colesevelam HCl Lowered LDL Cholesterol in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

... medications known as statins. Welchol, along with diet and exercise, also lowers blood sugar levels in adults with type 2 diabetes mellitus when added to other antidiabetic medications (metformin, sulfonylureas, or insulin). Ask your doctor if Welchol is right for you. Welchol is not ...

Sanofi Aventis: People With Type 2 Diabetes Treated With LANTUS(R) and APIDRA(R) Achieved Greater Reductions in A1C Than Those Treated With Pre-mixed Insulin

... Glulisine in Combination With Insulin Glargine in an Intensified Insulin Regimen to a Two-Injection Conventional Insulin Regimen in Type 2 Diabetes mellitus Patients With Poor Glycemic Control Pretreated With a Two-Injection Conventional Pre-mixed Insulin Therapy") showed that when compared to ...

Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months

... a predisposing factor. Appropriate clinical monitoring is advisable, particularly in diabetic patients and in patients with risk factors for diabetes mellitus for which regular glucose control is recommended. Undesirable alterations in lipids have been observed in olanzapine-treated patients in ...

TRANSCEND(TM) Trial Results Presented at European Society of Cardiology Congress and Published in The Lancet

... 55 years, who have had myocardial infarction, peripheral arterial occlusive disease, stroke or transient ischaemic attacks or suffer from diabetes mellitus and additional risk factors) and intolerant to widely-prescribed ACE inhibitors. Patients in the trial were randomized to treatment with telmisartan ...

After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008

... Diabetes Association (ADA) in San Francisco. BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a ...

Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight

... Diabetes Association (ADA) in San Francisco. BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a ...

The Largest Ever Study of Diabetes Shows Intensive Glucose Control Reduces Serious Complications

... and Vascular Disease) show that this intensive treatment strategy has the potential to benefit millions of diabetic patients worldwide. Diabetes mellitus is one of the greatest threats to the health of populations worldwide. Globally, there are approximately 250 million people with diabetes and that ...

Multiple Clinical Data Presentations at EuroPCR 2008 Support Use of OrbusNeich's Genous(TM) Bio-engineered R stent(TM) as Safe Alternative to Drug-Eluting Stents

... prospective, single-blind study involving patients with a high risk of restenosis. High risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 23 mm) and/or chronic total occlusions. "Interventional cardiologists ...

Tolerx Advancing Novel Type 1 Diabetes Agent into Phase III Clinical Trial Program Following End of Phase II FDA Meeting

... may benefit subjects with new-onset type 1 diabetes. In February, 2008 FDA released new draft guidance on developing drugs for diabetes mellitus and DEFEND incorporates key measures described within the guidance, in particular, stimulated C-peptide levels as a primary efficacy endpoint," said ...

U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

... and symptoms appear, discontinuation should be considered since TD may remit, partially or completely Hyperglycemia and diabetes mellitus -- Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical ...

Immunosyn Releases Wound Healing Photographs From the First Phase 'Proof of Concept Trial' in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019

... the US and Europe. Research suggests that SF-1019 has the potential to affect a number of clinical conditions including complications from Diabetic mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU), auto-immune disorders such as Multiple Sclerosis (MS) and neurological disorders such as ...

Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes

... (FDA) has approved Welchol(TM) (colesevelam HCl) to improve glycemic control (measured as hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents. Welchol is now the first ...

Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration

... develops. PREZISTA should be used with caution in patients with known sulfonamide allergy. New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship ...

Immunosyn Announces Biozyme Lab's Receipt of MHRA Manufacturing License Approval in Europe for the Biopharmaceutical SF-1019

... the US and Europe. Research suggests that SF-1019 has the potential to affect a number of clinical conditions including complications from Diabetic mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU), auto-immune disorders such as Multiple Sclerosis (MS) and neurological disorders such as ...

Immunosyn Corporation Releases SF-1019 Study Results

... the US and Europe. Research suggests that SF-1019 has the potential to affect a number of clinical conditions including complications from Diabetic mellitus such as Diabetic Neuropathy (DN) and diabetic ulcers (DU), auto-immune disorders such as Multiple Sclerosis (MS) and neurological disorders such as ...

Synvista Therapeutics Highlights New Data Demonstrating the Clinical Benefit of Vitamin E Therapy in Patients Identified on the Basis of Haptoglobin Phenotype Testing

... (AHA) Scientific Sessions 2007 in Orlando, Florida. The study demonstrated that supplementing Vitamin E therapy in patients with Diabetes mellitus (DM) who had the Haptoglobin 2-2 (Hp2-2) phenotype met its pre-specified, primary endpoint of decreased cardiovascular events, leading to early ...

Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeich's Genous(TM) Bio-engineered R Stent(TM) and Boston Scientific's Taxus(R) Stent in Patients at High Risk of Restenosis

... Genous to both drug-eluting and bare metal stents." For the TRIAS HR Pilot, high risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 20 mm) and/or chronic total occlusions. Genous is coated with an antibody ...

Enrollment Reaches 110 Patients in Investigator Initiated, Randomized Trial of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM)

... stent will receive at least six months of clopidogrel post-procedure. For TRIAS, high risk of restenosis is defined as patients who have diabetes mellitus and/or small vessels (less than 2.8 mm) and/or long lesions (greater than 20 mm). Target vessel failure is defined as cardiac death, myocardial ...

DiObex Begins Dosing Patients in Phase 2b Trial of Type 2 Diabetes Drug

... dosing patients in a Phase 2b clinical trial of DIO-902, a novel cortisol synthesis inhibitor being studied for the treatment of type 2 diabetes mellitus (T2DM). The Phase 2b multinational trial is a randomized, placebo-controlled, double-blinded study designed to evaluate the safety and efficacy ...

New Phase 3 Study in Treatment-Naive Adults with HIV Evaluates Efficacy and Safety of Once-Daily PREZISTA(TM)/ritonavir vs. KALETRA(R) as Part of HIV Combination Therapy

... rash develops. PREZISTA should be used with caution in patients with known sulfonamide allergy. New-onset or exacerbations of pre-existing diabetes mellitus and hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. A causal relationship ...

Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes

... control in patients with type 2 diabetes mellitus (type 2 diabetes). JANUVIA is indicated for: ... not be used in patients with type 1 diabetes mellitus (type 1 diabetes) or for the treatment of ... is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with ...

An Investigational Study Released at ADA Showed that Initial Combination Therapy with Januvia (sitagliptin) and Metformin Led to Improvement in Markers of Beta Cell Function in Patients with Type 2 Diabetes

... control in patients with type 2 diabetes mellitus (type 2 diabetes). JANUVIA is indicated for: ... not be used in patients with type 1 diabetes mellitus (type 1 diabetes) or for the treatment of ... is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with ...

New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir

... for the treatment of adults and children with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. ...