Investigational Combo Tablet Demonstrates Significant Reduction in HbA1c
The investigational combination tablet of empagliflozin and linagliptin reduced blood glucose levels in patients with type 2 diabetes as presented by Boehringer Ingelheim and Eli Lilly and Company at the 2014 American Diabetes Association Scientific Sessions.
The 24-week primary findings of the following two 52-week trials compared the combination of empagliflozin and linagliptin with empagliflozin or linagliptin alone in patients with type 2 diabetes and moderately elevated blood glucose levels. The first 52-week study randomized 686 adults with type 2 diabetes with moderate hyperglycemia at baseline (mean baseline of 8.0%) who were taking metformin. The study examined the change from baseline of hemoglobin A1C at 24 weeks in adults with a mean baseline A1C of 8.0%.
- Both empagliflozin/linagliptin combination doses showed statistically significant reductions in A1C vs. the empagliflozin component dose or linagliptin alone.
- Statistically significant more adults who had A1C levels of ≥7.0% at baseline achieved A1C levels < 7.0% after 24 weeks with both doses of the empagliflozin/linagliptin combination vs. either empagliflozin or linagliptin alone.
- Empagliflozin 25mg/linagliptin 5 mg: 61.8%
- Empagliflozin 10mg/linagliptin 5 mg: 57.8%
- Empagliflozin 25mg: 32.6%
- Empagliflozin 10mg: 28.0%
- Linagliptin 5mg: 36.1%
- For adults who had A1C levels of ≥8.5% at baseline, the following reductions in A1C were seen:
- The empagliflozin 25mg/linagliptin 5mg combination reduced A1C by 1.8%, compared with 1.2% for empagliflozin 25mg.
- The empagliflozin 10mg/linagliptin 5mg combination reduced A1C by 1.6%, compared with 1.3% for empagliflozin 10mg.
- Linagliptin 5mg alone reduced A1C by 1.0%.
- The empagliflozin/linagliptin combinations resulted in weight loss similar to that of empagliflozin monotherapy.
- Empagliflozin 25mg/linagliptin 5mg: body weight reduction of 3.0 kg from a mean baseline of 85.5 kg
- Empagliflozin 10mg/linagliptin 5mg: body weight reduction of 2.6 kg from a mean baseline of 86.6 kg
- Empagliflozin 25mg: body weight reduction of 3.2 kg from a mean baseline of 87.7 kg
- Empagliflozin 10mg: body weight reduction of 2.5 kg from a mean baseline of 86.1 kg
The second 52-week study of 677 adults with type 2 diabetes who were treatment-naïve examined the reduction in A1C from baseline at 24 weeks. As with the metformin study, adults in this study had moderate hyperglycemia at baseline.
- A1C reduction with the empagliflozin 10mg/linagliptin 5mg combination was significantly greater than that of empagliflozin 10mg alone.
- Compared with linagliptin 5mg, both combination doses significantly reduced A1C and body weight.
- Significantly more adults who had A1C levels of 7.0% or more at baseline achieved A1C levels less than 7.0% after 24 weeks with both doses of the empagliflozin/linagliptin combination vs. the empagliflozin component dose or linagliptin alone.
- Empagliflozin 25mg/linagliptin 5 mg: 55.4%
- Empagliflozin 10mg/linagliptin 5 mg: 62.3%
- Empagliflozin 25mg: 41.5%
- Empagliflozin 10mg: 38.8%
- Linagliptin 5mg: 32.3%
Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor which remove excess glucose through the urine by blocking blood glucose re-absorption in the kidney. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.