EASIE: Insulin Glargine vs Sitagliptin in Insulin-naïve Patients with Type 2 Diabetes Uncontrolled on Metformin

Aschner P, Chan J, Owens DR, et al; on behalf of the EASIE investigators. Insulin glargine versus sitagliptin in insulin-naïve patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicenter, randomised open-label trial.
Lancet. 2012;379(9833):2262-2269. 

More data from ADA 2012 are available in our OnsiteInsight® eNewsletter. Click here.  

The Evaluation of insulin glargine versus Sitagliptin in Insulin-naïve patients (EASIE) trial is a multicenter, randomized, parallel, open-label trial that examined the efficacy, safety, and tolerability of a basal insulin, insulin glargine, vs a DPP-4 inhibitor, sitagliptin, among insulin-naïve patients with type 2 diabetes that was uncontrolled on metformin.  

Subjects (aged 35-70 years, type 2 diabetes ≥6 months, A1C >7 and <11%, BMI 25-45 kg/m2, insulin naïve) were randomized over 24 weeks to insulin glargine (titrated from initial subcutaneous dose of 0.2 units/kg body weight to attain FPG 4.0-5.5 mmol/L) + metformin (n=250) or sitagliptin (100 mg qd oral dose) + metformin (n=265).  

Intermediate clinic visits occurred at Weeks 2, 6, 12, 16, and 24; intermediate telephone call visits occurred at Weeks 1, 3, 4, 5, 8, 10, and 20. In the safety population, 237 subjects were treated with glargine + metformin and 264 subjects were treated with sitagliptin + metformin. In the efficacy population, 227 subjects were treated with glargine + metformin and 253 subjects were treated with sitagliptin + metformin. The primary outcome is change in A1C from baseline to Week 24.  

Results:
Efficacy Population – Results at Week 24
 

  • Primary outcome, change in A1C from baseline to week 24: greater reduction in A1C was observed for glargine vs sitagliptin 
  Insulin glargine (n=227)   Sitagliptin (n=253)   Mean difference (95% CI); P 
 Mean reduction in A1C   -1.72% (SE, 0.06)   -1.13% (SE, 0.06)   -0.59% (-0.77 to -0.42); <0.0001 

SE=standard error  

  • 68% of glargine-treated subjects had A1C <7% vs 42% of sitagliptin-treated subjects (P<0.0001)  
  • 40% of glargine-treated subjects had A1C <6.5% vs 17% of sitagliptin-treated subjects (P<0.0001)  
  • A slight increase in weight was seen with glargine, and a slight decrease was observed with sitagliptin (1.51-kg between-group difference; P<0.0001)  

Safety Population  

  • Symptomatic hypoglycemia occurred among more subjects receiving glargine vs sitagliptin. Both severe symptomatic and severe nocturnal hypoglycemia were rare in either group. 
  •    Insulin glargine (n=237)   Sitagliptin (n=264)   Ratio (95% CI); P 
     All symptomatic hypoglycemia, events/patient year (SE)   4.21 (0.54)   0.50 (0.09)   8.45 (5.55-12.87); <0.0001 

SE=standard error 

  • There were no differences in adverse events between the treatment groups; serious treatment-emergent adverse events occurred in 6% of those receiving glargine and 3% of those receiving sitagliptin  

 

July 2012 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional/commercial interest. 

Related content: 

OnsiteInsight® eNewsletter: ADA 2012 

EASIE Trial: Design  

EASIE Trial: Study and Enrollment Profile  

EASIE Trial: Efficacy Population Primary Outcome at Week 24—Change in A1C from Baseline  

EASIE Trial: Efficacy Population A1C <7.0% and <6.5% Week 24  

EASIE Trial: Safety Population Hypoglycemia and Adverse Events  

Last Modified: 11/15/2013