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A Comparison of Three Insulin Regimens (Morning Glargine, Bedtime Glargine, or Bedtime Neutral Protamine Hagedorn) in Addition to a Pill for Treating Type 2 Diabetes FREE

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The summary below is from the full report titled “Glimepiride Combined with Morning Insulin Glargine, Bedtime Neutral Protamine Hagedorn Insulin, or Bedtime Insulin Glargine in Patients with Type 2 Diabetes. A Randomized, Controlled Trial.” It is in the 17 June 2003 issue of Annals of Internal Medicine (volume 138, pages 952-959). The authors are A. Fritsche, M.A. Schweitzer, H.-U. Häring, and the 4001 Study Group.

Ann Intern Med. 2003;138(12):I-33. doi:10.7326/0003-4819-138-12-200306170-00002
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What is the problem and what is known about it so far?

Type 2 diabetes mellitus is a common disease that interferes with the body's ability to store energy from food. The pancreas makes insulin, a substance that helps to store energy from food. People with type 2 diabetes make insulin but can't use it properly. The result is high blood sugar levels. Over time, high blood sugar can lead to blindness, kidney failure, nerve damage, and heart disease. Fortunately, keeping blood sugar under control can prevent complications. Although some people with type 2 diabetes can control their blood sugar with diet and exercise, drug treatment is often necessary. Some diabetes drugs are pills, but often these pills are not enough. These patients must take insulin injections (either alone or with pills) to control blood sugar levels. There are several types of insulin. Short-acting insulins begin to act soon after injection. Long-acting insulins do not begin to act for several hours and then continue to act for hours. Most long-acting insulins “peak,” meaning that they work most strongly to lower blood sugar at a certain time after injection. During this peak, a person can develop dangerously low blood sugar levels (hypoglycemia) unless enough food is available. Hypoglycemia is particularly dangerous during sleep because patients may not know that their blood sugar is low and that they need to eat. Insulin glargine is the newest long-acting insulin. Glargine is different from other long-acting insulins because it does not peak. Glargine works to lower blood sugar a little at a time over 24 hours. The best way to use glargine in type 2 diabetes is unknown.

Why did the researchers do this particular study?

To see whether patients with type 2 diabetes taking a diabetes pill have better blood sugar control if they add morning insulin glargine, bedtime insulin glargine, or bedtime neutral protamine Hagedorn (NPH) insulin to their usual regimens.

Who was studied?

695 adults with type 2 diabetes who were taking diabetes pills but not insulin.

How was the study done?

The researchers assigned patients to take insulin glargine in the morning, insulin glargine at bedtime, or NPH insulin at bedtime for 24 weeks in addition to the diabetes pill glimepiride. The researchers measured patients' blood sugar control by using a test called hemoglobin A1c. They also compared the frequency of nighttime hypoglycemia in the three groups.

What did the researchers find?

Blood sugar control improved in all three groups, but patients who took morning glargine improved the most. Patients taking morning or bedtime glargine had fewer episodes of nighttime hypoglycemia.

What were the limitations of the study?

The results might not apply to patients taking different or no diabetes pills. In addition, the study lasted only 24 weeks.

What are the implications of the study?

When doctors add long-acting insulin to a diabetes pill for patients with type 2 diabetes, a morning injection of insulin glargine may be a better way to control blood sugar in type 2 patients than bedtime glargine or bedtime NPH.





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