(20th June, 2014); Boehringer Ingelheim and Eli Lilly and Company presented results of two Phase III clinical trials studying the efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in adults with Type 2 Diabetes (T2D) at the American Diabetes Association's 74th Scientific Sessions®. Results showed that empagliflozin in combination with certain other diabetes therapies reduced blood glucose, body weight and blood pressure.
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" Phase III data from two clinical trials presented at the American Diabetes Association's 74th Scientific Sessions® Added to metformin, empagliflozin demonstrated significantly greater reductions in blood glucose and body weight versus glimepiride, in a two-year studyAdded to multiple daily insulin injections in obese adults on high insulin doses, empagliflozin significantly reduced blood glucose and body weight with lower insulin doses compared to placebo.
In a two-year study, empagliflozin demonstrated significantly greater reductions in blood glucose, body weight and blood pressure compared with glimepiride, when both were added-on to metformin in adults with T2D. In a second, 52-week study of obese adults with T2D on high insulin doses with or without metformin, adding empagliflozin to multiple daily insulin injections significantly reduced blood glucose and body weight with lower insulin doses compared with placebo.
“The progressive nature of Type 2 Diabetes often means that more than one medication is needed to manage blood glucose levels,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “The encouraging results from these trials show that empagliflozin taken in combination with either metformin, or with multiple daily injections of insulin, reduced blood glucose levels and body weight in adults with Type 2 Diabetes.”
Empagliflozin versus glimepiride as add-on to metformin
This two-year study of 1,545 adults with T2D compared the efficacy and safety profiles of empagliflozin 25 mg with glimepiride (1–4 mg), each in combination with metformin. After two years, patients taking empagliflozin had significantly greater reductions in HbA1c (average blood glucose over the past two to three months), body weight and blood pressure compared with patients taking glimepiride:
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Mean reduction in HbA1c levels was 0.66 percent for empagliflozin compared with 0.55 percent for glimepiride.
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Mean change in body weight was a reduction of 3.1 kg for empagliflozin compared with an increase of 1.3 kg for glimepiride.
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Mean change in systolic blood pressure was a reduction of 3.1 mmHg for empagliflozin compared with an increase of 2.5 mmHg for glimepiride.
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Mean change in diastolic blood pressure was a reduction of 1.8 mmHg for empagliflozin compared with an increase of 0.9 mmHg for glimepiride
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Significantly fewer confirmed hypoglycaemic events were reported for empagliflozin compared with glimepiride (2.5 percent vs. 24.2 percent, respectively). Overall adverse event rates were similar in the two groups (86.4 percent and 86.3 percent, for empagliflozin and glimepiride, respectively). Urinary tract infections were reported in 13.7 percent of patients treated with empagliflozin and 13.1 percent of patients treated with glimepiride, and genital infections were reported in 11.8 percent and 2.2 percent, respectively.
Empagliflozin versus placebo in obese, inadequately controlled patients with T2D on multiple daily insulin injections
This one year study of 375 obese adults with T2D and inadequately controlled blood glucose levels, assessed the safety and efficacy of empagliflozin 10 mg or 25 mg added on to multiple daily insulin injections, with or without metformin. Mean initial levels of HbA1c for patients in this study was 8.3 percent. Compared with placebo, patients in each of the empagliflozin groups had significant reductions in HbA1c at week 18 and 52. Results at week 52 also showed reductions in body weight and lower insulin doses with empagliflozin added to multiple daily insulin injections, versus placebo.
After 18 weeks:
- Significant reductions from initial HbA1c levels of 0.94 percent and 1.02 percent with empagliflozin 10 mg and 25 mg, respectively, compared to 0.50 percent with placebo.
After 52 weeks:
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Significant reductions from initial HbA1c levels of 1.18 percent and 1.27 percent with empagliflozin 10 mg and 25 mg, respectively, compared to 0.81 percent with placebo.
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Patients in the empagliflozin 10 mg and 25 mg groups were taking mean total daily insulin doses that were 8.8 IU/day and 11.2 IU/day lower, respectively, than the dose patients in the placebo group were taking.
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More patients with initial HbA1c levels greater than or equal to 7 percent and treated with empagliflozin, achieved HbA1c levels below 7 percent (31 percent, 42 percent and 21 percent of patients in the empagliflozin 10 mg, 25 mg and placebo groups, respectively).
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Average reduction in body weight of 2 kg for patients in each of the empagliflozin groups compared with a gain of 0.4 kg for those in the placebo group.
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Hypoglycaemia was reported in 51.1 percent, 57.7 percent and 58.8 percent of patients in the empagliflozin 10 mg, 25 mg and placebo groups, respectively.
