Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes

Andrew Lewin, Ralph A Defronzo, Sanjay Patel, Dacheng Liu, Renee Kaste, Hans J. Woerle, Uli C. Broedl

Research output: Contribution to journalArticle

117 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate the efficacy and safety of empagliflozin/linagliptin in subjects with type 2 diabetes.

RESEARCH DESIGN AND METHODS: Subjects not receiving antidiabetes therapy for ≥12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134), or linagliptin 5 mg (n = 135) for 52 weeks. The primary end point was change from baseline in HbA1c at week 24.

RESULTS: Mean HbA1c at baseline was 7.99-8.05% (64 mmol/mol). At week 24, adjusted mean (SE) changes from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg were -1.08 (0.06)% (-11.8 [0.7] mmol/mol), -1.24 (0.06)% (-13.6 [0.7] mmol/mol), -0.95 (0.06)% (-10.4 [0.7] mmol/mol), -0.83 (0.06)% (-9.1 [0.7] mmol/mol), and -0.67 (0.06)% (-7.3 [0.7] mmol/mol), respectively. Reductions in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg (P < 0.001) but not compared with empagliflozin 25 mg and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with the individual components (P < 0.001 for both). At week 24, 55.4%, 62.3%, 41.5%, 38.8%, and 32.3% of subjects with baseline HbA1c ≥7% (≥53 mmol/mol) reached HbA1c <7% with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg, respectively. Efficacy was maintained at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks was similar across groups (68.9-81.5%), with no confirmed hypoglycemic AEs.

CONCLUSIONS: Reductions from baseline in HbA1c with empagliflozin/linagliptin were significantly different versus linagliptin and empagliflozin 10 mg but not versus empagliflozin 25 mg. Empagliflozin/linagliptin was well tolerated.

Original languageEnglish (US)
Pages (from-to)394-402
Number of pages9
JournalDiabetes Care
Volume38
Issue number3
DOIs
StatePublished - Mar 1 2015

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Type 2 Diabetes Mellitus
Linagliptin
empagliflozin
Hypoglycemic Agents

ASJC Scopus subject areas

  • Medicine(all)

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Lewin, A., Defronzo, R. A., Patel, S., Liu, D., Kaste, R., Woerle, H. J., & Broedl, U. C. (2015). Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. Diabetes Care, 38(3), 394-402. https://doi.org/10.2337/dc14-2365

Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. / Lewin, Andrew; Defronzo, Ralph A; Patel, Sanjay; Liu, Dacheng; Kaste, Renee; Woerle, Hans J.; Broedl, Uli C.

In: Diabetes Care, Vol. 38, No. 3, 01.03.2015, p. 394-402.

Research output: Contribution to journalArticle

Lewin, A, Defronzo, RA, Patel, S, Liu, D, Kaste, R, Woerle, HJ & Broedl, UC 2015, 'Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes', Diabetes Care, vol. 38, no. 3, pp. 394-402. https://doi.org/10.2337/dc14-2365
Lewin, Andrew ; Defronzo, Ralph A ; Patel, Sanjay ; Liu, Dacheng ; Kaste, Renee ; Woerle, Hans J. ; Broedl, Uli C. / Initial combination of empagliflozin and linagliptin in subjects with type 2 diabetes. In: Diabetes Care. 2015 ; Vol. 38, No. 3. pp. 394-402.
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AU - Lewin, Andrew

AU - Defronzo, Ralph A

AU - Patel, Sanjay

AU - Liu, Dacheng

AU - Kaste, Renee

AU - Woerle, Hans J.

AU - Broedl, Uli C.

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N2 - OBJECTIVE: To evaluate the efficacy and safety of empagliflozin/linagliptin in subjects with type 2 diabetes.RESEARCH DESIGN AND METHODS: Subjects not receiving antidiabetes therapy for ≥12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134), or linagliptin 5 mg (n = 135) for 52 weeks. The primary end point was change from baseline in HbA1c at week 24.RESULTS: Mean HbA1c at baseline was 7.99-8.05% (64 mmol/mol). At week 24, adjusted mean (SE) changes from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg were -1.08 (0.06)% (-11.8 [0.7] mmol/mol), -1.24 (0.06)% (-13.6 [0.7] mmol/mol), -0.95 (0.06)% (-10.4 [0.7] mmol/mol), -0.83 (0.06)% (-9.1 [0.7] mmol/mol), and -0.67 (0.06)% (-7.3 [0.7] mmol/mol), respectively. Reductions in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg (P < 0.001) but not compared with empagliflozin 25 mg and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with the individual components (P < 0.001 for both). At week 24, 55.4%, 62.3%, 41.5%, 38.8%, and 32.3% of subjects with baseline HbA1c ≥7% (≥53 mmol/mol) reached HbA1c <7% with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg, respectively. Efficacy was maintained at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks was similar across groups (68.9-81.5%), with no confirmed hypoglycemic AEs.CONCLUSIONS: Reductions from baseline in HbA1c with empagliflozin/linagliptin were significantly different versus linagliptin and empagliflozin 10 mg but not versus empagliflozin 25 mg. Empagliflozin/linagliptin was well tolerated.

AB - OBJECTIVE: To evaluate the efficacy and safety of empagliflozin/linagliptin in subjects with type 2 diabetes.RESEARCH DESIGN AND METHODS: Subjects not receiving antidiabetes therapy for ≥12 weeks were randomized to empagliflozin 25 mg/linagliptin 5 mg (n = 137), empagliflozin 10 mg/linagliptin 5 mg (n = 136), empagliflozin 25 mg (n = 135), empagliflozin 10 mg (n = 134), or linagliptin 5 mg (n = 135) for 52 weeks. The primary end point was change from baseline in HbA1c at week 24.RESULTS: Mean HbA1c at baseline was 7.99-8.05% (64 mmol/mol). At week 24, adjusted mean (SE) changes from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg were -1.08 (0.06)% (-11.8 [0.7] mmol/mol), -1.24 (0.06)% (-13.6 [0.7] mmol/mol), -0.95 (0.06)% (-10.4 [0.7] mmol/mol), -0.83 (0.06)% (-9.1 [0.7] mmol/mol), and -0.67 (0.06)% (-7.3 [0.7] mmol/mol), respectively. Reductions in HbA1c were significantly greater for empagliflozin 25 mg/linagliptin 5 mg compared with linagliptin 5 mg (P < 0.001) but not compared with empagliflozin 25 mg and were significantly greater for empagliflozin 10 mg/linagliptin 5 mg compared with the individual components (P < 0.001 for both). At week 24, 55.4%, 62.3%, 41.5%, 38.8%, and 32.3% of subjects with baseline HbA1c ≥7% (≥53 mmol/mol) reached HbA1c <7% with empagliflozin 25 mg/linagliptin 5 mg, empagliflozin 10 mg/linagliptin 5 mg, empagliflozin 25 mg, empagliflozin 10 mg, and linagliptin 5 mg, respectively. Efficacy was maintained at week 52. The proportion of subjects with adverse events (AEs) over 52 weeks was similar across groups (68.9-81.5%), with no confirmed hypoglycemic AEs.CONCLUSIONS: Reductions from baseline in HbA1c with empagliflozin/linagliptin were significantly different versus linagliptin and empagliflozin 10 mg but not versus empagliflozin 25 mg. Empagliflozin/linagliptin was well tolerated.

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