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Phase III Data Show Investigational Compound Empagliflozin Reduced Blood Glucose In Adults With Type 2 Diabetes Treated With Basal Insulin


Data presented at the 73rd Scientific Sessions® also showed reduction in required insulin dose in treated study subjects

and Eli Lilly and Company have announced results of a 78week Phase III clinical trial of the investigational compound empagliflozin* as an addon to in people with (T2D). The study, presented at the American Diabetes Association (ADA) 73rd Scientific Sessions®, showed that empagliflozin 10mg and 25mg, produced statistically significant reductions in HbA1c (average blood glucose), compared to placebo as addon to basal insulin, at the time of assessment of the study’s primary endpoint, week 18, as well as at week 78.1

Empagliflozin is a member of the sodium glucose cotransporter 2 (SGLT2) inhibitor class of drugs and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by reducing glucose reabsorption in the kidney.

“This study is an important component of the clinical programme of the Boehringer Ingelheim and Lilly Diabetes alliance, which is designed to examine empagliflozin as an addon therapy to a broad range of existing treatments for people with Type 2 Diabetes,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The results observed in this study are encouraging as empagliflozin in combination with basal insulin demonstrated significant improvements in glucose control as well as weight loss”.

The study included an 18week fixed insulin dose period, after which the dose was adjusted at investigator discretion.1 Results of the study with empagliflozin as an addon to basal insulin in people with T2D included:

  • At week 18, placeboadjusted reductions in HbA1c for empagliflozin 10mg and 25mg of 0.6% and 0.7% (p<0.001), respectively.1
  • Confirmed hypoglycaemia (glucose ≤70mg/dL and/or requiring assistance) was reported in 20%, 28% and 21% of patients on empagliflozin 10mg, 25mg and placebo respectively, at week 18.
  • At week 78, placeboadjusted reductions in HbA1c for empagliflozin 10mg and 25mg of 0.5% and 0.6% (p<0.001), respectively. Daily insulin dose was changed from baseline by 1.2IU, 0.5IU and 5.5IU for empagliflozin 10mg, 25mg and placebo, respectively.1
  • Both empagliflozin doses and placebo had comparable confirmed hypoglycaemic events (glucose ≤70mg/dL and/or requiring assistance); 36% reported by patients on both empagliflozin 10mg and 25mg, and 35% on placebo, at week 78.

Adverse events were reported by 85% and 87% of patients on empagliflozin 10mg and 25mg, respectively and by 87% of patients on placebo at week 78. Common adverse events included hypoglycaemia (see rates detailed above 2 patients on empagliflozin 25mg required assistance), as well as adverse events consistent with urinary tract infection (reported in 15%, 12% and 9% of patients on empagliflozin 10mg, 25mg and placebo, respectively) and genital infection (reported in 8%, 5% and 2% of patients on empagliflozin 10mg, 25mg and placebo, respectively).

Further analysis also showed at week 78:

  • A statistically significant reduction in body weight of 2.2kg (p<0.001) and 2.0kg (p<0.001) for empagliflozin 10mg and 25mg, respectively, compared to an increase of 0.7kg for placebo.
  • Changes in systolic blood pressure were statistically significant in the empagliflozin 10mg group [4.1mmHg (p=0.004)] but not in the empagliflozin 25mg group [2.4mmHg (p=0.099)], compared to placebo [0.1mmHg].1

About the study

The 78week, randomised, doubleblind placebocontrolled trial investigated the safety and efficacy of empagliflozin as an addon to basal insulin in people with T2D. Patients were randomised to receive empagliflozin 10mg (n=169), empagliflozin 25mg (n=155) or placebo (n=170). Basal insulin dose remained constant for the first 18 weeks. Thereafter, adjustments were allowed at investigator discretion. Primary endpoint was change from baseline in HbA1c at week 18. Key secondary endpoints were changes from baseline in insulin dose and HbA1c at week 78.1

Empagliflozin is being investigated in adults with T2D in a Phase III clinical trial programme that plans to enrol more than 14,500 patients. This programme comprises more than 10 multinational clinical trials, including a large cardiovascular outcomes trial.

*Empagliflozin is an investigational compound. Its safety and efficacy have not been established.

Source

1Rosenstock J et al, Empagliflozin as Add-On to Basal Insulin for 78 Weeks Improves Glycemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM). Poster No: 1102-P. Presented at the American Diabetes Association® (ADA) 73rd Scientific Sessions. June 21-25, Chicago, IL.

2International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.

3Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and pre-diabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Center for Disease Control and Prevention, 2011.

4International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes?