Intensive Insulin Therapy in Type 2 Diabetes (T2D) Patients Previously Treated with Glargine Plus Oral Agents: Prandial NPL/Lispro Mixtures vs Glargine/Lispro Basal/Bolus

Rosenstock, Julio; Ahmann, Andrew J.; Colon, Gildred; Scism-Bacon, Jamie L.; Jiang, Honghua H.; Martin, Sherry
June 2007
Diabetes;Jun2007 Supplement 1, Vol. 56, pA51
Academic Journal
We report the first head-to-head comparison of intensive insulin therapies (intensive mixtures therapy [IMT] vs basal bolus therapy [BBT]) in T2D patients previously treated with glargine (≥30 U/d) + oral agents. Patients with A1C ≥ 7.5 and ≤ 12% were randomized to IMT (lispro mix 50/50; 50% NPL, 50% lispro; n=187) rid with meals or BBT (glargine at bedtime + mealtime lispro; n=187) in a 24-wk, multicenter, open-label, non-inferiority trial using structured insulin titration to achieve fasting/preprandial plasma glucose (PG) <110 mg/dL (<6.1 mM). Patients on IMT not reaching FPG target could switch to lispro mix 75/25 (75% NPL; 25% lispro) at the PM meal. Baseline characteristics were similar (mean): age 55yrs, diabetes duration 11yrs, BMI 34 kg/m² and A1C (IMT 8.8%, BBT 8.9%, P=0.6041). At wk 24, A1C was lower with BBT (6.8 vs 6.9%, P=0.021) and A1C was reduced significantly from baseline for both therapies (P<0.0001). The difference in A1C change from baseline to endpoint (BBT minus IMT) was -0.22% with a 90% CI from -0.38% to -0.06%. Non-inferiority was not demonstrated based on the pre-specified margin of 0.3%. The % of patients on IMT vs BBT achieving target A1C <7.0% was 54% vs 69% (P=0.009) and for target ≤6.5% was 35% vs 50% (P=0.01), but did not differ for target ≤6.0% (14.6% vs 14.3%, P=1.0) or for target <7.5% (81% vs 83%, P=0.76). Treatment with BBT was associated with higher insulin dose (1.38 U/kg vs 1.17 U/kg, P=0.002). Weight gain was similar for both groups (IMT: 3.98 kg vs BBT: 4.55 kg, P=0.22). Rates of overall, nocturnal, severe hypoglycemia, or hypoglycemia confirmed by PG values were also similar. In conclusion, as non-inferiority of IMT to BBT was not demonstrated, findings on A1C reduction, % achieving specific A1C targets, hypoglycemia, insulin dose, and number of injections need to be considered in the individual decision-making process of selecting IMT vs BBT in T2D necessitating intensive insulin therapy.


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