Insulin Glargine in Type 2 Diabetes Mellitus

Summary

Primary objective: * To compare efficacy of oral antidiabetics (OAD) combination therapy with either HOE901 insulin analogue once daily or Lispro insulin analogue at mealtime in terms of change in HbA1c (baseline to endpoint). Secondary objectives: * To compare the OAD combination therapy with either HOE901 insulin analogue once daily or Lispro insulin analogue at mealtime in terms of efficacy and safety.

Timeline

Start

2003-06

Primary completion

2005-05

Completion

—

Outcome

Met primary endpoint

paper which was within the predefined limit of 0.4% for non-inferiority (difference=0.157; 95% Cl -0.008 to 0.322). PMID 18374840 ↗

Publications

• Results Bretzel RG, Nuber U, Landgraf W, Owens DR, Bradley C, Linn T. Once-daily basal insulin glargine versus thrice-daily prandial insulin lispro in people with type 2 diabetes on oral hypoglycaemic agents (APOLLO): an open randomised controlled trial. Lancet. 2008 Mar 29;371(9618):1073-84. doi: 10.1016/S0140-6736(08)60485-7.

Drugs

Indications