Reviews and reports

IQWiG: No proof long-acting insulin analogues outperform human insulin for Type 2 diabetes

This review by IQWiG concluded that it could find no proof long-acting insulin analogues are better than human insulin in long-term outcomes in people with type 2 diabetes.

IQWiG, was looking primarily at long-term outcomes, such as diabetes-related complications, heart and eye problems. It examined the available literature, concentrating in particular on longer-term studies. It also asked the two manufacturers concerned for additional information, which was supplied.

Of the 18 studies examined, nine compared glargine [Lantus] and Neutral Protamine Hagedorn (NPH) insulin, six compared detemir [Levemir] with NPH insulin, while the three others compared the two analogues against each other.

IQWiG commented that there was insufficient data to be able to be certain on the long-term implications, so there were indications, but no proof.  IQWiG’s statement said that although there was one five-year study on the use of glargine, it offered little information in terms of diabetes-related complications. Where heart disease was concerned, the comparison with NPH insulin showed no difference.

  • Although the FDA had suggested that glargine could increase the risks of eye fundus damage, prompting Sanofi to conduct a long-term study, there was no indication this was the case.
  • IQWiG also failed to find any proof of advantages in shorter-term effects, although there were some indications that, for example, under certain circumstances, mild hypoglycaemia appears to occur less frequently with insulin detemir.
  • The report said the five-year-study shows some indication that serious hypoglycaemia occurs less frequently under glargine than with NPH insulin.
  • In direct comparison to each other, neither of the two analogue insulins performed clearly better. People in the detemir [Levemir] group on average gained less weight than those in the glargine [Lantus] group. However, the differnce was only slight – between 0.9 and 1.3 kilos but as the studies were of short duration, between six and 12 months, it remained unclear how lasting this effect is.

    In the light of these findings, IQWiG has recommended that long-acting analogue insulins are not funded for people with Type 2 diabetes.