Insulin Analogues and Severe Hypoglycaemia

Summary

Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

Timeline

Start

2007-05

Primary completion

2011-11

Completion

2012-08

Publications

• Pedersen-Bjergaard U, Kristensen PL, Norgaard K, Perrild H, Jensen T, Thorsteinsson B, Nikolajsen A, Tarnow L. Short-term cost-effectiveness of insulin detemir and insulin aspart in people with type 1 diabetes who are prone to recurrent severe hypoglycemia. Curr Med Res Opin. 2016 Oct;32(10):1719-1725. doi: 10.1080/03007995.2016.1205006. Epub 2016 Jul 20.
• Agesen RM, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L, Pedersen-Bjergaard U. Effect of insulin analogues on frequency of non-severe hypoglycaemia in patients with type 1 diabetes prone to severe hypoglycaemia: The HypoAna trial. Diabetes Metab. 2016 Sep;42(4):249-55. doi: 10.1016/j.diabet.2016.03.001. Epub 2016 Apr 7.
• Pedersen-Bjergaard U, Kristensen PL, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Hougaard P, Parving HH, Thorsteinsson B, Tarnow L. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):553-61. doi: 10.1016/S2213-8587(14)70073-7. Epub 2014 May 2.
• Kristensen PL, Pedersen-Bjergaard U, Beck-Nielsen H, Norgaard K, Perrild H, Christiansen JS, Jensen T, Parving HH, Thorsteinsson B, Tarnow L. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design. BMC Endocr Disord. 2012 Jun 22;12:10. doi: 10.1186/1472-6823-12-10.

Drugs

Indications