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主题:【糖尿病系列】写在前面 -- 青方

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The high levels of blood sugar that occur in diabetes can damage the kidneys, heart and liver. Based on a protein found in the saliva of the venomous Gila monster, this injection lowers blood sugar only when it is too high. It helped patients in three late-stage clinical trials, each of which tested exenatide in combination with different diabetes drugs, and may help patients lose weight. Merck and Novartis are developing pills that work through a similar mechanism. Exenatide was submitted to the FDA on June 30. A new drug application has been accepted by the FDA, and a regulatory decision is expected by April 30, 2005.

Insulin is an incredibly effective drug. There's only one problem: It is only available as an injection, which often scares patients away. Clinical trials have shown that Exubera, or inhaled insulin, works as well as injected insulin for both Type 1 and Type 2 diabetes. Worries that it might cause pulmonary problems have lingered. Recently released studies seem to confirm the product's safety, but a new drug application may not be filed until sometime in 2005, when more safety data are available. Eli Lilly and Alkermes are working on a similar drug.

The competition to develop drugs that target more than one of the cellular signals called peroxisome proliferation activation receptors (PPARs) is one of the most heated contests in the drug industry. Such medicines could control both cholesterol and blood sugar. Unfortunately, two recent attempts faltered after causing cancer in laboratory animals. Among those remaining, AstraZeneca's Galida is in late-stage trials, trailing an effort by Bristol and Merck. Hints of kidney safety issues have some worried; AstraZeneca is running clinical trials in patients with kidney problems to try and dispel those concerns. Eli Lilly and GlaxoSmithKline are working on similar drugs.

LAF237 is racing a similar drug from Merck, MK-0431, to become the first pill to raise a protein called glucagon-like peptide. The payoff would be a drug that controls blood sugar only when it is too high, cutting the risk of hypoglycemia. At the moment, Novartis has released more data on its drug than Merck, including a useful comparison to exenatide, the injection being developed by Eli Lilly. Findings presented June 7 indicated that the drug can effectively control blood sugar both alone and in combination with another diabetes drug, metformin. Novartis expects to submit an application to regulators in 2006.

MK-0431 is racing a similar drug from Novartis, LAF237, to become the first pill to raise a protein called glucagon-like peptide. The payoff would be a drug that controls blood sugar only when it is too high, cutting the risk of hypoglycemia. Merck even hopes that its drug may cause weight loss in diabetics but has released less data than Novartis. A Food and Drug Administration application is expected in 2006.

Bristol-Myers Squibb is leading the race to develop drugs that target more than one of the cellular signals called peroxisome proliferation activation receptors (PPARs). Such medicines could control both cholesterol and blood sugar. Unfortunately, two recent attempts faltered after causing cancer in laboratory animals. But Bristol's muraglitazar is powering ahead. On April 28, the drug giant announced it had inked a deal with rival Merck to co-develop and promote the drug, which could by submitted to the U.S. Food and Drug Administration within the next nine to 12 months.

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