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New study calls for prompt insulin treatment on failure of diet, exercise & oral diabetes medications
Paris, France | Tuesday, June 10, 2008, 08:00 Hrs  [IST]

Results from a new study presented at the American Diabetes Association's (ADA) 68th Annual Scientific Sessions reinforce the importance of promptly initiating insulin treatment when patients with type 2 diabetes are unable to achieve recommended glycemic targets with diet, exercise and oral diabetes medications alone.

In the TULIP (Testing the Usefulness of Lantus when Initiated Promptly in patients with type 2 diabetes) clinical study, 66 per cent of patients who began treatment with the long-acting, basal insulin Lantus (insulin glargine [rDNA origin] injection) achieved A1C <7 per cent, the ADA's recommended target for glycemic control, while only 38 per cent of patients from the lifestyle management arm were able to achieve the recommended target levels.

In an effort to help guide treatment decisions, the ADA and European Association for the Study of Diabetes (EASD) developed a Consensus Algorithm for type 2 diabetes that calls for healthcare providers and diabetes patients to initiate insulin therapy when A1C <7 per cent is not achieved with oral medications and lifestyle management alone.

However, physicians typically wait for A1C to approach 9 per cent before adding insulin. In general, every percentage point drop in A1C blood test results (e.g., from 8.0 per cent to 7.0 per cent) reduces the risk of microvascular complications (eye, kidney, and nerve diseases) by 40 per cent.

The most common side effect of any insulin, including Lantus, is hypoglycemia, which may be serious.

In the Lantus arm of the TULIP trial, there were 4.2±6.6 (p<0.0001) cases of symptomatic, 0.7±2.1 (p=0.0011) cases of nocturnal and 0.04±0.35 (p=0.147) cases of severe hypoglycemia events reported per patient year. However, no patients dropped out of the trial due to hypoglycaemia.

"When glycemic targets are not achieved with diet, exercise and oral medications given at maximum tolerated dose, patients with type 2 diabetes have reached a critical moment in the lifecycle of their condition," said Andre Grimaldi, MD, Professor Diabetes Department Head, Pitié-Salpêtrière Hospital, Paris, France. "The results observed in TULIP demonstrate the value of following the ADA/EASD treatment recommendations by initiating basal insulin therapy in a timely manner."

TULIP is a 9-month, 12-visit, open-label, multinational, multicenter, randomized study to evaluate starting Lantus or intensifying lifestyle management in type 2 diabetes patients aged 40-75 years, body mass index (BMI) 24-35 kg/m2 and A1C 7-8 per cent, treated with maximum doses of metformin and sulfonylurea for =2 years. Lantus was injected once-daily and titrated to capillary fasting blood glucose 70-100 mg/dL.

Lantus is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and paediatric patients (6 years of age and older) with type 1 diabetes mellitus. Lantus demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours. Lantus is the number one prescribed insulin worldwide.

Apidra is a rapid-acting insulin analog with a unique zinc-free molecular structure that maintains a rapid onset and a short duration of action, indicated for adult patients with type 1 and type 2 diabetes. Apidra offers patients mealtime dosing flexibility-it can be taken within 15 minutes before or soon after meal (within 20 minutes after starting a meal). Apidra is also flexible for use in wide range of patients from lean to obese.

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