TABLE 1.

Basaglar (Insulin Glargine; LY2963016) Clinical Trials

Clinicaltrials.gov IdentifierComparative AgentStudy PopulationTrial TypePrimary Objective(s)Results
NCT01634165 (5)Insulin glargine (Lantus)Healthy subjects
(n = 24)
Randomized, double-blind, active-controlled, crossover studyAUC and Cmax
(pharmacokinetics)
No statistical analysis, but the PK of LY2963016 0.3–0.6 units/kg in healthy volunteers appear to be similar to the PK of Lantus (same dose range)
NCT01600950 (6)Insulin glargine (Lantus)Type 1 diabetes
(n = 20)
Randomized, double-blind, active-controlled, crossover studyDuration of action
(pharmacodynamics)
No statistical analysis, but the PD of duration of action appear similar between LY2963016 0.3 units/kg and Lantus (same dose)
NCT01476345 (7)Insulin glargine (Lantus)Diabetes mellitus
(n = 80)
Randomized, double-blind, active-controlled, crossover studyAUC and Cmax
(pharmacokinetics)
No statistical analysis, but PK of LY2963016 0.5 units/kg in patients with diabetes mellitus appear to be similar to the PK of Lantus (same dose)
NCT01688635 (8)Insulin glargine (Lantus)Healthy subjects
(n = 91)
Randomized, double-blind, active-controlled, crossover studyAUC and Cmax
(pharmacokinetics)
No statistical analysis, but AUC and Cmax of LY2963016 0.5 units/kg appears to be similar to those of Lantus (same dose)
NCT01374178 (9)Insulin glargine (Lantus)Diabetes mellitus
(n = 16)
Randomized, open-label, active-controlled, crossover studyAUC
(pharmacokinetics)
No statistical analysis, but AUC of LY2963016 0.5 units/kg appears to be similar to the AUC of Lantus (same dose)
NCT01421459 (10)Insulin glargine (Lantus); oral antihyperglycemic medicationsType 2 diabetes mellitus
(n = 756;
376 LY2963016
and 380 Lantus)
Randomized, double-blind, active-controlled, parallel-arm studyChange in A1C from baseline to 24 weeksLY2963016 + oral antihyperglycemic agents was noninferior to Lantus + oral antihyperglycemic agents:
• A1C decreased by 1.286 (SE 0.06) in the LY2963016 arm and by 1.338 (SE 0.06) in the Lantus arm after 24 weeks of therapy
• Mean difference was 0.052 (95% CI –0.07 to 0.175, P = 0.403); analyzed by ANCOVA
NCT01421147 (11)Insulin glargine (Lantus); insulin lisproType 1 diabetes mellitus
(n = 535;
268 LY2963016
and 267 Lantus)
Randomized, open-label, active-controlled, parallel-arm studyChange in A1C from baseline to 24 weeksLY2963016 + insulin lispro was noninferior to Lantus + insulin lispro:
• A1C decreased by 0.352 (SE 0.053) in the LY2963016 arm and by 0.460 (SE 0.054) in the Lantus arm after 24 weeks of therapy
• Mean difference was 0.108 (95% CI –0.002 to 0.219, P = 0.055); analyzed by ANCOVA
NCT02302716 (12)Insulin glargine (Lantus); oral antihyperglycemic medicationsType 2 diabetes mellitusRandomized, open-label, prospective, parallel-arm studyChange in A1C from baseline to 24 weeksStudy is ongoing; no results are available
  • ANCOVA, analysis of covariance; AUC, area under the curve; Cmax, maximum plasma concentration; PK, pharmacokinetics; PD, pharmacodynamics; SE, standard error.