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insulin therapy
Jack L. Leahy
Insulin Therapy:
 Univ. of Vermont, Burlington. Comprehensive and current clinically based resource for physicians and residents. Covers background, rationale for optimal glycemia control in diabetes and standards of care, injection/glucose-monitoring equipment, dietary practices, application of principles, and prevention and therapy.

  

discovery of insulin   
Michael Bliss
The Discovery of Insulin
: Bliss's book is a real page-turner and deserves a much wider reading. The research is solid, and he does a great job of drawing the sometimes sordid details of medical discovery and controversy. He makes an excellent point that those of us who are non- diabetics should remember--there's still no cure.

diabetes spectrum magazine

Diabetes Spectrum:  This bimonthly magazine translates the latest diabetes research advances into practical treatment advice. Diabetes spectrum is designed for the nurse, educator, dietitian, pharmacist every member of the health care team. More Like This

diabetes news headlines and research                                                       diabetes research information
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Diabetes research, clinical trials, study links
Drug developments in diabetes research and treatment
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NOTE:  This page contains limited information.  Please see our Diabetes News Headlines section for complete current drug developments, and our archived diabetes drug research articles.

Archived headlines:
Drug research & development
Diabetes Medications, Devices, Product Recalls & Warnings
FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings

Mini Site Index
Under FDA Review
FDA Approved Drugs - 2005
Drug & Supplement Warnings
FDA Recalled Drugs
Experimental Drug Trials & Studies 
Failed Drug Trials & Drugs Rejected by the FDA
On the Horizon:  New Drug Concepts

Is Vitamin E Safe?   Despite recent reports that show use of high-dose vitamin E supplements is associated with a higher overall risk of dying, at least one group stands to benefit greatly from the same vitamin.  About 40 percent of diabetic patients can reduce their risk of heart attacks and of dying from heart disease taking vitamin E supplements, according to a Technion-Israel Institute of Technology study published in the November 2004 Diabetes Care.

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diabetes drug research

FDA drug and supplement warnings

Diabetes Medications, Devices, Product Recalls & Warnings
FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings

FDA Warns Consumers about Brazilian Diet Pills Found to Contain Active Drug Ingredients Emagrece Sim and Herbathin Dietary Supplements May be Harmful - FDA, January 13, 2006

  • Avandamet Warnings Issued. January 6, 2006, ST. LOUIS (MD Consult) - On January 5, 2006, the US Food and Drug Administration (FDA) and GlaxoSmithKline notified health care professionals about postmarketing reports of new-onset and worsening diabetic macular edema for patients receiving rosiglitazone. In the majority of these cases, the patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved after discontinuation of therapy, and in 1 case macular edema resolved after dose reduction.
  • GlaxoSmithKline products containing this medication include Avandia (rosiglitazone maleate) and Avandamet (rosiglitazone maleate/metformin hydrocholoride), both indicated for the treatment of type 2 diabetes mellitus. This new safety information will be added to product information for prescribers and patient information materials for both Avandia and Avandamet.

    Macular edema typically occurs in association with diabetic retinopathy, although it is more likely to occur as retinopathy progresses. Risk factors for macular edema include duration of diabetes, presence of retinopathy, hypertension, and poor glycemic control. Symptoms suggestive of macular edema include blurred or distorted vision, decreased color sensitivity, and decreased dark adaptation.
     

  • Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products (From the FDA, Novebmer 9, 2005)
  • This notice is intended to alert physicians, nurses, medical technologists, pharmacists and other healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. The GDH-PQQ method of glucose determination is non-specific for glucose and, in the presence of maltose, xylose, or galactose, may yield falsely elevated glucose readings.

    Although this is a known drug-device interaction (1-5), there have been reports of the inappropriate administration of insulin and consequent life-threatening/ fatal hypoglycemia in response to erroneous test results obtained from patients receiving parenteral products containing maltose. Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. Since hypoglycemia may be life threatening, it is important that health care providers prescribing and/or administering products containing the above sugars be aware of possible interference leading to incorrect results. A preliminary listing of U.S. products that may cause interference is presented in Table 1....
     

  • Cymbalta may increase risk for liver damage, Lilly cautions  October 18, 2005.  ST. LOUIS (MD Consult) - "On October 17, 2005, Eli Lilly and the US Food and Drug Administration (FDA) notified health care professionals of a revision to the Precautions/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain..."
     
  • Potential for dispensing errors prompts change in labeling for Novolog insulins.  September 15, 2005.  ST. LOUIS (MD Consult) - On August 26, 2005, Novo Nordisk Incorporated and the US Food and Drug Administration notified pharmacists of an initiative implemented to help prevent dispensing errors. Until recently, the product packaging for NovoLog Mix 70/30, a premixed insulin analog, and NovoLog, a rapid-acting insulin analog, were very similar.
     
  • FDA Warns:  Phenergan Can Cause Death In Children Under Age 2.  February 18, 2005.  ST. LOUIS (MD Consult) - On February 16, 2005, the U.S. Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program, MedWatch, announced a change to the prescribing information for Phenergan (promethazine). In January 2005 the drug's manufacturer, Wyeth, notified health care professionals of revisions to the Contraindications, Warnings/Use in Pediatric Patients, and Dosage and Administration sections of the medication's labeling. Phenergan is contraindicated for use in pediatric patients younger than 2 years of age because of the potential for fatal respiratory depression.
     
  • Counterfeit Drugs Purchased in Mexico Unsafe, Warns FDA.  May 11, 2005, ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) issued an alert on May 10, 2005, warning the public about the sale of counterfeit versions of Lipitor (atorvastatin calcium), Viagra (sildenafil citrate), and an unapproved product promoted as "generic Evista" (raloxifene hydrochloride) to US consumers at pharmacies in Mexican border towns.
     
  • GlaxoSmithKline Products Seized Due to Violation of Good Manufacturing Practice.  March 10, 2005.  ST. LOUIS (MD Consult) - In a response to ongoing concerns about manufacturing quality, on March 4, 2005, the U.S. Food and Drug Administration (FDA) and the Department of Justice initiated seizures of Paxil CR (paroxetine) and Avandamet (rosiglitazone maleate/metformin hydrochloride) tablets manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and type II diabetes (Avandamet), failed to meet the standards laid out by the FDA that ensure product safety, strength, quality, and purity.
     
  • FDA Warns Consumers Supplement Liqiang 4 Could Be Dangerous.  July 6, 2005.  ST. LOUIS (MD Consult) - On July 1, 2005, the US Food and Drug Administration (FDA) issued a nationwide warning to consumers not to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide, a drug that could have serious, life-threatening consequences in some persons.
  • Glyburide is a drug used to lower blood sugar and is safe and effective when used as labeled in FDA-approved medications. Persons who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities. Consumers who have this product should dispose of it immediately.

      


FDA approved drugs - 2005  

  • Drug Approved for Treatment of Iron Overload due to blood transfusions. On November 3, 2005, pharmaceutical company Novartis announced the approval of Exjade (deferasirox) by the US Food and Drug Administration (FDA). Exjade, the first once-daily oral iron chelator, has been approved for the treatment of chronic iron overload due to blood transfusions in adults and children aged 2 years and older.  11/04/2005
  • Exjade is the only iron chelator administered as a drink (the tablets are dispersed in a glass of orange juice, apple juice, or water), compared with the current standard of care, which often requires a subcutaneous infusion lasting 8 to 12 hours per night, for 5 to 7 nights per week for as long as the patient continues to receive blood transfusions or has excess iron within the body. As a result, many patients may have stopped or avoided iron chelation therapy, thus risking the toxic effects of iron overload.

    The approval of Exjade is expected to greatly enhance the acceptance of iron chelation therapy, especially for children, and offer a new alternative to the burdensome continuous infusion therapy. 

  • Combination Children's Vacine Approved.  September 7, 2005, ST. LOUIS (MD Consult) - Merck & Co, Inc, announced on September 6, 2005, that the US Food and Drug Administration has approved the combination vaccine Proquad (measles, mumps, rubella, and varicella virus vaccine live) for simultaneous vaccination against measles, mumps, rubella, and varicella in children aged 12 months to 12 years. Proquad is the first vaccine approved in the United States to help protect against these 4 diseases in a single shot. Proquad is also approved for use in children 12 months to 12 years of age if a second dose of measles, mumps, and rubella vaccine is to be administered
  • Byetta (Exenatide) Approved for Treatment in Type 2 Diabetes
    Company: Amylin/Eli Lilly
    Approval Status: Approved April, 2005
  • Byetta (exenatide), derived from a compound found in the saliva of the Gila monster, a large lizard native to the southwestern US, is a functional analog of Glucagon-Like Peptide-1 (GLP-1), a naturally occuring peptide which enhances insulin secretion in response to elevated plasma glucose levels. By mimicking the function of GLP-1, the drug helps more strongly activate this pathway to improve glycemic control. 

    Byetta is specifically indicated as adjunctive therapy to improve glycemic control in patients with Type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of both, but have not achieved adequate glycemic control.

  • Increlex Receives FDA Approval, August 26, 2005 - Increlex (mecasermin), a drug from Tercicia was approved fby the FDA in August 2005 for the treatment of growth failure in pedicatric patients. Increlex contains recombinant-DNA-engineered human insulin-like growth factor-1 (rhIGF-1). It is designed to replace natural IGF-1 in pediatric patients who are deficient, promoting normalized statural growth.  Also, see Mosby's Drug Consult..... "For more than 30 years, growth hormone has been the only treatment option endocrinologists have had for children with short stature due to hormonal deficiency," said Philippe Backeljauw, MD, Division of Endocrinology, Cincinnati Children's Hospital and a coinvestigator in the phase III trial conducted for Increlex. "The availability of Increlex will enable physicians to offer a more specific treatment for children whose growth failure is linked to abnormally low blood IGF-1 levels."  
  • Exubera (inhaled insulin) - FDA Approves Inhaled Insulin Exubera - The Food and Drug Administration finally approved the first inhaled insulin. Exubera is an inhaled powder made of recombinant human insulin (produced through a genetic engineering process) for the treatment of adult patients with type 1 and type 2 diabetes.   01/27/2006
  • Exubera's headline history:

    FDA Delays Approval of Inhaled Insulin:   "The Food and Drug Administration is delaying a final decision on the first inhalable form of insulin for three months while it reviews chemistry data on the diabetes treatment."  Associated Press, October 28, 2005

    FDA Panel Urges Approval of Inhaled Insulin:  Exubera Offers People With Diabetes an Alternative to Insulin Injections.  Sept. 8, 2005 (Washington) -- A government advisory panel has backed approval of the first insulin inhaler. The device offers people with diabetes an alternative to insulin injections for controlling their blood sugar.  Todd Zwilich, Wed Md News, September 8, 2005.

    Pfizer's Exubera Could Be Approved By October 2005.  UBS maintained a buy rating and $34 price target on the healthcare giant. ... The FDA committee voted 7-2 in favor of approval of Exubera for type 1 and 2 diabetes. The inhaled insulin is being developed with partners Sanofi-Aventis.

  • Symlin Approved by the FDA - A new antihpyerglycemia drug, pramlintide acetate (brand name Symlin), has been approved by the FDA for people with type 1 diabetes whose A1C levels are not in an acceptable target range.  It is also approved for those with type 2 diabetes who use insulin and are not meeting their A1C objectives.
  • Pramlintide is a synthetic form of the hormone amylin normally produced by the beta cells along with insulin.  Amylin, insulin, and a third hormone called glucagon all work together to maintain normal glucose levels.  Studies show a modest improvement in A1C levels for individuals adding pramlintide to their diabetes care routine.

    A press release from Amylin Pharmaceuticals, the company that makes Symlin, warns that not all patients may be suitable for administration of pramlintide as it increases a risk for severe hypoglycemia.  Pramlintide’s primary side effect for new patients is nausea, however, patients can learn to adjust their dose thereby minimizing discomfort.
    Read the Symlin Press Release

    FDA Approves New Diabetes Drug:  Symlin for use in patients with type 1 or type 2 disease; Associated Press, March 17, 2005    

      


Drugs under FDA review

Drug research & development
Diabetes Medications, Devices, Product Recalls & Warnings
FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings

      


Clinical drug trials, experimental and drugs of the future

Drug research & development
Diabetes Medications, Devices, Product Recalls & Warnings
FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings

Dual Purpose Drugs:  New Medications Targeting Both Blood Sugar and Fats

  • New Diabetes Drug May Control Cholesterol:  Experimental Pill Targets Blood Fat as Well as Sugar;  Reuters, June 13, 2005.   If approved, Pargluva, or muraglitazar, would be the first insulin sensitizer to target lipids as well.  Pargluva is being developed by Bristol-Myers Squibb and Merck & Co. Inc.
     
  • Diuretics Effective for People with Diabetes and High Blood Pressure:  In people with diabetes, diuretics work as well as ACE-inhibitors and calcium channel blockers in protecting against heart attack and improving survival, and offer more protection against congestive heart failure.  NIH News, Monday June 27, 2005.
     
  • Diabetes Technology & Therapeutics, December 2004, Volume 6, No. 6:  Thiazolidinediones (rosiglitazone & pioglitazone):  A Review of Their Mechanisms of Insulin Sensitization, Therapeutic Potential, Clinical Efficacy, and Tolerability.  
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    Drugs rejected by FDA or failed in clinical trials

    Drug research & development
    Diabetes Medications, Devices, Product Recalls & Warnings
    FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings

    • MK-767:  "Licensed from a Japanese drugmaker, this pill was to be the first of a class of drugs that would control cholesterol and blood sugar. Millions of Americans have Type 2 diabetes, in which the body stops responding to or producing insulin. Current medicines control blood sugar levels but don't help with cholesterol. Cardiovascular disease causes 80% of deaths among diabetics. MK-767 turned out to cause cancer in rats, but fortunately several similar drugs are in development by other companies."

          


    Drugs recalled by the FDA

    Drug research & development
    Diabetes Medications, Devices, Product Recalls & Warnings
    FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings

    • FDA Alerts US Residents to Recall of Counterfeit Lipitor Sold in the United KingdomAugust 5, 2005.  ST. LOUIS (MD Consult) - On July 29, 2005, the US Food and Drug Administration (FDA) alerted US residents to the recent recall of a batch of counterfeit Lipitor (atorvastatin) sold in the United Kingdom (UK). Lipitor is used to treat high cholesterol.  The counterfeit Lipitor 20-mg tablets were recalled in the United Kingdom on July 28, 2005. Health authorities in the United Kingdom stated that initial results of tests performed on the counterfeit drugs do not indicate this product poses an immediate risk to patients; however, they advise patients to stop taking the drug and to return it to the pharmacy where they obtained it. UK pharmacies are being advised to return all remaining stock of this batch to Pfizer Ltd, the manufacturer of Lipitor.

    • Herbal products contain drugs for diabetes:  Posted 3-6-2000,   By Mary Ann Hellinghausen;  Sacramento, Calif. Five brands of herbal products found to contain prescription drugs used to treat diabetes could be dangerous to consumers, especially those with diabetes, warn the California Department of Health Services (CDHS) and the Food and Drug Administration (FDA). The recalled products are: Diabetes Hypoglucose Capsules and Pearl Hypoglycemic Capsules, both sold by Chinese Angel Health Products of Santa Monica, Calif.; Sino American’s Zhen Qi Capsules; and Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules and Tongyi Tang Diabetes Angel Hypoglycemic Capsules.
       
    • Rezulin was recalled by the FDA in March of 2000 due to 94 liver-related deaths associated with rezulin use.

          


    Drugs on the horizon

    Drug research & development
    Diabetes Medications, Devices, Product Recalls & Warnings
    FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings

            

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    Page Updated 05/03/2006