Page 564 - fbkCardioDiabetes_2017

540 Initiation & Intensification of Insulin Therapy in T2DM

A single bolus insulin, added to insulin glargine and OADs, resulted in significantly improved HbA1c levels

Proof of Concept (POC) Study: comparing Basal Plus
therapy with insulin glargine alone

• Subjects:
– Insulin treated (135 included, 106 randomized) with type 2 diabetes (HbA1c 7.5–
9.5% )
– Received basal insulin and metformin for ≥3 months, (OHAs continued during
study)

Mean study entry values:
• HbA 1c (%): 8.5
• BMI (kg/m ): 33.1 Insulin glargine (n=57)
2
• Diabetes duration (years): 11.5
Insulin glargine (n=135)
3 months
Insulin glargine + once-daily insulin glulisine (n=49)
Randomization 3 months
(subjects with HbA 1c ≥7.0%)

POC Study: adding glulisine to glargine further
improves glycemic control

Randomization
Endpoint
p=0.029*
40 9
<7.0 30 p=0.0499 8

% achieving HbA 1c 20 22.4 HbA 1c (%) 7 8.0 7.8 7.8 7.5

10

0 8.8 6
Control Glargine Control Glargine
group + glulisine group + glulisine
Additionally, Basal Plus approach is safe & associated with only minor weight
gain
*for difference in change in HbA
1c
Sanofi-aventis data on file. Basal Plus (POC) study

GCDC 2017