For patients with type 2 diabetes
Levemir® once dailya had low rates of hypoglycemia1
In TITRATE™, a 20-week randomized clinical trial1:
Low rates of hypoglycemia in patients with type 2 diabetes being treated to reach A1C goal <7%1,b
FPG=fasting plasma glucose.
Results from a 20-week, randomized, controlled, multicenter, open-label, parallel-group, treat-to-target trial using a physician-directed self-titration algorithm in insulin-naïve patients with type 2 diabetes, A1C ≥7% and ≤9% on oral antidiabetic drug (OAD) therapy, randomized to Levemir® and OAD (1:1) to 2 different FPG titration targets (70-90 mg/dL [n=122] or 80-110 mg/dL [n=122]). At study end, in the 80-110 mg/dL group, 55% of patients achieved goal (A1C ≤7%) with a mean A1C decrease of 0.9%. The mean A1C was 7%. The mean FPG reduction was 50.4 mg/dL.1
bMinor=self measured plasma glucose <56 mg/dL and not requiring third-party assistance; major=requiring third-party assistance.
Adapted from Blonde et al, 2009.1
aLevemir® can be dosed once or twice daily.2
All patients received Levemir® injection once daily1,a
In the same study, mean FPG values decreased in the first 8 weeks, then remained generally flat, with a total drop of 57.6 mg/dL in the 70-90 mg/dL group and 50.4 mg/dL drop in the 80-110 mg/dL group.1
In TRANSITION™, a 26-week randomized clinical trial3:
Low rates of minor hypoglycemia in patients being treated with metformin + sitagliptin + Levemir®3,c
Results from TRANSITION™, a 26-week, open-label, randomized, parallel-group study in patients with type 2 diabetes. Insulin-naïve patients concomitantly treated with metformin +/– a second OAD were randomized to receive either once-dailya Levemir® + sitagliptin + metformin (n=111; metformin continued while all other OADs discontinued) or sitagliptin + metformin +/– sulfonylurea (SU) (n=111; metformin and SU continued while all other OADs discontinued. SU was allowed to be discontinued at the discretion of the investigator.) The primary study end point was A1C after 26 weeks.3
cMinor = self-treatable and plasma glucose (PG) <56 mg/dL, with or without symptoms; major = unable to self-treat.
Adapted from Hollander et al, 2011.3
There were no major hypoglycemic events in either treatment group3
In the same study, mean FPG decreased by 66.3 mg/dL after 26 weeks in the metformin + sitagliptin + Levemir® arm and by 22.2 mg/dL in the metformin + sitagliptin ± SU arm.3
In DeVries et al; combination study4:
Low rates of hypoglycemia over 26 weeks in patients being treated with metformin + Victoza®d + Levemir®2,3,e-g
dVictoza® is a GLP-1 receptor agonist.
eDuring the main treatment period.
fNonsevere=PG <56 mg/dL (patients able to self-treat).
Severe=any event requiring third-party assistance irrespective of PG levels.
gOne patient in the metformin + Victoza® arm was excluded due to the 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.
This was a multinational, open-label study of 988 insulin-naïve adults with type 2 diabetes (aged 18 to 80 years) who were uncontrolled on metformin ≥1500 mg/day +/– SU. All patients underwent a 12-week run-in with metformin and Victoza® once daily, titrated to 1.8 mg. At the end of the run-in period, if patients achieved A1C <7%, they continued treatment in a nonrandomized, observational arm (50% of patients from run-in). If A1C was ≥7% at the end of run-in, patients were randomized to 26 weeks of once-dailya Levemir® as add-on therapy or to continued, unchanged treatment with Victoza® 1.8 mg and metformin.4
Adapted from DeVries et al, 2012.4
In the same study, there were significant reductions in A1C and FPG over 26 weeks when Levemir® once dailyb was added to metformin + Victoza®.2,3
In PREDICTIVE, an observational trial6:
Once-dailya efficacy and low rates of hypoglycemia were also shown in patients with type 2 diabetes in whom Levemir® was added to OADs or patients were converted at baseline from other basal insulin therapies +/– OADs or patients were converted at baseline from other basal insulin therapies +/– OADs6
Results from the German cohort of PREDICTIVE (n=10,276): a multicenter observational study evaluating the efficacy and safety of Levemir® in patients with diabetes over 14.5 weeks. Subgroup analysis of patients with type 2 diabetes further evaluated the efficacy and safety of Levemir® when adding to or switching from OAD therapy (n=1321); NPH insulin ± OAD therapy (n=251); or insulin glargine U-100 ± OAD therapy (n=260).6
Adapted from Meneghini et al, 2007.6