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1.  Newly Approved Drug Therapies (729) Novolog Mix 70/30, Novo Nordisk,
...acting formulation. It has been approved in a subcutaneous injection formulation, for the control of hyperglycemia. Hyperglycemia is an abnormally increased content of sugar in the blood. Diabetes is a chronic disease ...
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2.  Study Posting (2246) Trial #117729, Diabetes Mellitus Types I and II, Duarte, CA
...Trial #117729, Diabetes Mellitus Types I and II, Duarte, CA Trial Information Molecular Mechanisms of Hyperglycemia and Diabetes Induced Monocyte Activation You have been asked to participate in this research study ...
...Diabetes Mellitus Types I and II description: CenterWatch Clinical Research Trial Posting: Molecular Mechanisms of Hyperglycemia and Diabetes Induced Monocyte Activation ...
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3.  Newly Approved Drug Therapies (35) Precose (acarbose), Bayer,
...indicated as an adjunct to diet to lower blood glucose in subjects with NIDDM whose hyperglycemia cannot be managed on diet alone. Precose may also be used in combination with sulfonylurea ...
...conducted. The study involved 354 subjects with NIDDM. Clinical studies demonstrated a strong association between hyperglycemia and an increased risk of microvascular tissue damage. Trials involving Precose established that hemoglobin levels ...
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4.  Newly Approved Drug Therapies (619) Lantus (insulin glargine [rDNA origin] injection), Sanofi-aventis,
...w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia General Information Lantus is the first FDA approved long-acting (basal) recombinant human insulin analog ...
...treatment of adults with Type 2 diabetes who require basal insulin for the control of hyperglycemia. The chemical structure of Lantus allows for regulated release of the insulin into the circulation ...
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5.  Newly Approved Drug Therapies (806) Metaglip (glipizide/metformin HCl), Bristol-Myers Squibb,
...to diet and exercise, to improve glycemic control in patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone. Metaglip is also indicated as second ...
...week, double-blind, active-controlled, multicenter international clinical trial, patients with type 2 diabetes, whose hyperglycemia was not adequately controlled with diet and exercise alone were randomized to receive initial therapy ...
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6.  Newly Approved Drug Therapies (451) Glyburide Tablets, Mylan Laboratories,
...the blood glucose level in patients with non-insulin dependent Diabetes Mellitus (Type II), whose Hyperglycemia cannot be controlled by diet alone. Jobson Medical Information • Privacy | • Glossary Copyright © 1995-2010 Jobson ...
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7.  Newly Approved Drug Therapies (1031) Lantus (insulin glargine [rDNA origin] injection), Sanofi-aventis,
...with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. Lantus is supplied as 10 mL vials, 3 mL cartridges or as a 3 mL ...
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8.  Newly Approved Drug Therapies (528) Avandia (rosiglitazone maleate), SmithKline Beecham,
...events reported in clinical trials of Avandia were: upper respiratory tract infection, headache, back pain, hyperglycemia, fatigue, and sinusitis. Mechanism of Action Pharmacological studies in animal models indicate that rosiglitazone improves ...
...activity of rosiglitazone has been demonstrated in animal models of type II diabetes in which hyperglycemia and/or impaired glucose tolerance is a consequence of insulin resistance in target tissues. Rosiglitazone ...
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9.  CenterWatch: Endocrinology Approved Drug Therapies
...Approved August 2001 Novolog Mix 70/30 ; Novo Nordisk; Subcutaneous injection for the control of hyperglycemia, associated with type 1 and 2 diabetes, Approved November 2001 Prozac Weekly (fluoxetine HCl) ; Eli ...
...w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000 Lantus (insulin glargine [rDNA origin] injection) ; Sanofi-aventis; For the treatment of ...
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10. Clinical Trial Results by Drug Names
...the target range specified by the health care provider. Secondary: frequency of events of hypoglycemia, hyperglycemia, emergency department and unscheduled hospitalization for severe hypoglycemia or severe hyperglycemia, and frequency and reasons for outpatient visits for diabetes; total labor costs and amount of ...
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11.  Newly Approved Drug Therapies (643) Trisenox (arsenic trioxide), Cell Therapeutics,
...effects include, but are not limited to: • leukocytosis • nausea • vomiting • diarrhea • abdominal pain • fatigue • edema • hyperglycemia • dyspnea • cough • rash or itching • headaches • dizziness In clinical trials these side effects usually did ...
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12.  Newly Approved Drug Therapies (801) Avandamet (rosiglitazone maleate and metformin HCl), GlaxoSmithKline,
...Upper respiratory tract infection • Diarrhea • Injury • Anemia • Headache • Sinusitis • Fatigue • Back pain • Viral infection • Arthralgia • Hyperglycemia A small number of people who have been treated with metformin have developed the serious ...
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13.  CenterWatch: List of Newly Approved Drug Thearapies
...w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000 Lantus (insulin glargine [rDNA origin] injection) ; Sanofi-aventis; For the treatment of ...
...w/Type 1 diabetes, or adults w/Type 2 diabetes requiring basal insulin to control hyperglycemia, Approved April 2000 Neurontin (gabapentin) oral solution ; Parke-Davis; For the treatment of partial seizures ...
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14.  Study Posting (2829) Trial #157574, Diabetic Neuropathy, San Antonio, TX
...or to or limb amputation • Hospitalized within the last month for episodes of hypoglycemia or hyperglycemia • History of progressive or neurologic disorders (such as multiple sclerosis, amyotrophic lateral sclerosis) Tracy Critchfield ...
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15.  CenterWatch: New Medical Therapies in Disease Category (55), Diabetes Mellitus Types I and II
...reported in most studies of inhaled insulin formulations. Furthermore, the drug successfully controlled post-prandial hyperglycemia for over two hours, indicating clinical utility. This open-label study enrolled 7 subjects with ...
...of type II diabetes. The pooled data indicated that the drug was efficacious in reducing hyperglycemia, with 12 weeks of treatment producing significant mean reductions in HbA1C levels compared to placebo ...
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16.  CenterWatch: New Medical Therapies in Disease Category (229), Diabetic Foot Ulcers
...reported in most studies of inhaled insulin formulations. Furthermore, the drug successfully controlled post-prandial hyperglycemia for over two hours, indicating clinical utility. This open-label study enrolled 7 subjects with ...
...of type II diabetes. The pooled data indicated that the drug was efficacious in reducing hyperglycemia, with 12 weeks of treatment producing significant mean reductions in HbA1C levels compared to placebo ...
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17.  Newly Approved Drug Therapies (61) Humalog (insulin lispro), Eli Lilly,
...ate. Taking insulin too close to a meal can increase a subject's risk of hyperglycemia (high blood sugar) shortly after the meal and hypoglycemia (low blood sugar) before the next ...
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18.  Newly Approved Drug Therapies (232) Glyset (miglitol), Bayer,
...In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of poptprandial hyperglycemia. Because its mechanism of action is different, the effect of Glyset to enhance glycemic control ...
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19.  Newly Approved Drug Therapies (579) Cafcit Injection, Roxane Laboratories,
...exceed 50 mg/L. In clinical studies reported in the literature, cases of hypoglycemia and hyperglycemia have been observed. Therefore, serum glucose may need to be periodically monitored in infants receiving ...
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20.  Newly Approved Drug Therapies (842) Mylotarg (gemtuzumab ozogamicin), Wyeth,
...patients receiving Mylotarg during clinical trials: • Chills • Fever • Nausea • Vomiting • Headache • Hypotension • Hypertension • Hypoxia • Dyspnea • Hyperglycemia Fewer infusion-related adverse events were experienced by patients during the second dose. Mechanism of ...
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