The new data, a sub-analysis from a large, multinational study called PREDICTIVE™, are important because many people with type 2 diabetes gain weight when they start on other, conventional types of insulin therapy, further increasing their already high risk of cardiovascular disease.[2]

“Many people with type 2 diabetes are overweight or obese to begin with, and starting insulin therapy often leads to even more weight gain,” said lead investigator Dr Anne Dornhorst. “Our findings showed that not only did Levemir® once daily improve glycemic control, but unlike many other forms of insulin, it actually led to weight loss and this benefit was even greater for the heaviest patients.”

PREDICTIVE™ (Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation) is a multinational, open-label, prospective, observational study to evaluate the safety and efficacy of Levemir® in people with type 1 and type 2 diabetes from more than 20 countries. The new data presented at IDF were from a 14-week analysis of a European subgroup of 2,377 individuals with type 2 diabetes who were being treated with OADs and had not previously used insulin therapy. Upon entering the study, these patients started taking Levemir®, dosed with or without their previous OADs, based on their physician’s clinical judgement. Most patients (82%) used Levemir® once daily.

The results indicate that after 14 weeks, the individuals taking Levemir® lost 0.7 kg of body weight (1.5 lbs) compared to baseline (p<0.001). The weight loss was more pronounced in those who entered the trial at higher weight. For example, those who had a body mass index (BMI, a measure of weight for height) between 27 and 29, which is considered overweight, lost an average of 0.56 kg (1.2 lbs), whereas those with a BMI at 31 or higher (considered obese) lost 1.51 kg (3.3 lbs). These reductions in weight were significant (p<0.0001) compared to baseline. As expected, Levemir® improved glycemic control over the 14 weeks. The average level of HbA1c, an indicator of long-term glycemic control, decreased from 8.9% to 7.6% – over a period of three months. All these improvements in glycemic control were significant (p<0.0001).

Hypoglycemia (low blood sugar) is also a concern in people with diabetes, and the risk of hypoglycemia can be increased with insulin therapy. However, the study showed that the incidence of hypoglycemic episodes four weeks after starting Levemir® was actually less than it was four weeks before the study: 1.2 vs 1.4, 0 vs 0.1 and 0.3 vs 0.4 episodes/patient-year for total, major and night-time hypoglycemic episodes, respectively. The decrease in major episodes was statistically significant (p<0.001).

[1] Dornhorst A, Hernandez FO, Koenen C, Lüddeke H-J;. Poster presentation at: 19th world congress of the International Diabetes Federation, Capetown, South Africa, December 3-7, 2006. [2] Ridderstrale M, Gudbjornsdottir S, Eliasson B, Nilsson PM, Cederholm J, Steering Committee of the Swedish National Diabetes Register (NDR). Obesity and cardiovascular risk factors in type 2 diabetes: results from the Swedish National Diabetes Register. J Intern Med 2006; 259(3): 314–322.

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