Empagliflozin as Add On to Basal Insulin for 78 Weeks Improves Glycemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM)

Rosenstock, Julio; Jelaska, Ante; Wang, Fei; Kim, Gabriel; Broedl, Uli C.; Woerle, HJ; Bajaj, Harpreet S.

doi:10.1016/j.jcjd.2013.08.093

Cited by 34 publications

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“…Finally, SGLT2 inhibition in insulin-treated patients with type 2 diabetes does not substantially increase the risk of hypoglycemia (8,9). We recognize that a smaller and individualized reduction in insulin doses at initiation of study drug may have provided greater glycemic efficacy in the current study.…”

Section: Discussionmentioning

confidence: 75%

Sodium-Glucose Cotransporter 2 Inhibition and Glycemic Control in Type 1 Diabetes: Results of an 8-Week Open-Label Proof-of-Concept Trial

et al. 2014

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OBJECTIVEAdjunctive-to-insulin therapy with sodium-glucose cotransporter 2 (SGLT2) inhibition may improve glycemic control in type 1 diabetes (T1D). RESEARCH DESIGN AND METHODSWe evaluated the glycemic efficacy and safety of empagliflozin 25 mg daily in 40 patients treated for 8 weeks in a single-arm open-label proof-of-concept trial (NCT01392560). RESULTSMean A1C decreased from 8.0 6 0.9% (64 6 10 mmol/mol) to 7.6 6 0.9% (60 6 10 mmol/mol) (P < 0.0001), fasting glucose from 9.0 6 4.3 to 7.0 6 3.2 mmol/L (P = 0.008), symptomatic hypoglycemia (<3.0 mmol/L) from 0.12 to 0.04 events per patient per day (P = 0.0004), and daily insulin dose from 54.7 6 20.4 to 45.8 6 18.8 units/day (P < 0.0001). Mean urinary excretion of glucose increased from 19 6 19 to 134 6 61 g/day (P < 0.0001). Weight decreased from 72.6 6 12.7 to 70.0 6 12.3 kg (P < 0.0001), and waist circumference decreased from 82.9 6 8.7 to 79.1 6 8.0 cm (P < 0.0001). CONCLUSIONSThis proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with T1D.

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Section: Discussionmentioning

confidence: 75%

Sodium-Glucose Cotransporter 2 Inhibition and Glycemic Control in Type 1 Diabetes: Results of an 8-Week Open-Label Proof-of-Concept Trial

et al. 2014

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“…In phase III studies, empagliflozin used as monotherapy or as an add-on to metformin, metformin plus sulfonylurea, pioglitazone (with or without metformin), or basal insulin improved glycemic control and consistently reduced body weight and blood pressure (8)(9)(10)(11)(12). Empagliflozin is potentially an attractive option for use in combination with insulin, as its mechanism of action is independent of b-cell function (13), it generates weight loss, and it is associated with a low risk of hypoglycemia (8)(9)(10)(11)(12).…”

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confidence: 99%

Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes

et al. 2014

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OBJECTIVEWe investigated the efficacy and safety of the sodium glucose cotransporter 2 inhibitor, empagliflozin, added to multiple daily injections of insulin (MDI insulin) in obese patients with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODSPatients inadequately controlled on MDI insulin 6 metformin (mean HbA 1c 8.3% [67 mmol/mol]; BMI 34.8 kg/m 2 ; insulin dose 92 international units/day) were randomized and treated with once-daily empagliflozin 10 mg (n = 186), empagliflozin 25 mg (n = 189), or placebo (n = 188) for 52 weeks. Insulin dose was to remain stable in weeks 1-18, adjusted to meet glucose targets in weeks 19-40, then stable in weeks 41-52. The primary end point was change from baseline in HbA 1c at week 18. Secondary end points were changes from baseline in insulin dose, weight, and HbA 1c at week 52. RESULTSAdjusted mean 6 SE changes from baseline in HbA 1c were 20.50 6 0.05% (25.5 6 0.5 mmol/mol) for placebo versus 20.94 6 0.05% (210.3 6 0.5 mmol/mol) and 21.02 6 0.05% (211.1 6 0.5 mmol/mol) for empagliflozin 10 mg and empagliflozin 25 mg, respectively, at week 18 (both P < 0.001). At week 52, further reductions with insulin titration resulted in changes from baseline in HbA 1c of 20.81 6 0.08% (28.9 6 0.9 mmol/mol), 21.18 6 0.08% (212.9 6 0.9 mmol/mol), and 21.27 6 0.08% (213.9 6 0.9 mmol/mol) with placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively, and final HbA 1c of 7.5% (58 mmol/mol), 7.2% (55 mmol/mol), and 7.1% (54 mmol/mol), respectively. More patients attained HbA 1c <7% (<53 mmol/mol) with empagliflozin (31-42%) versus placebo (21%; both P < 0.01). Empagliflozin 10 mg and empagliflozin 25 mg reduced insulin doses (29 to 211 international units/day) and weight (22.4 to 22.5 kg) versus placebo (all P < 0.01) at week 52. CONCLUSIONSIn obese, difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses, empagliflozin improved glycemic control and reduced weight without increasing the risk of hypoglycemia and with lower insulin requirements.

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“…Auch in der Add on Behandlung zu Ba salinsulin verringerte sich das Gewicht mit Empagliflozin im Durchschnitt um 2 kg und blieb auch nach 78 Wochen auf diesem niedrigeren Niveau. Im Vergleich dazu stieg in der Placebo Gruppe das Körpergewicht um 0,4 kg an [11].…”

Section: Forum Der Industrieunclassified

“…Eine moderate Reduktion des systoli schen Blutdrucks † beruht wohl auf der mit der Glukosurie verbundenen milden Diurese, die unabhängig von der Begleit medikation erfolgt [7,[9][10][11][12]. Das Aus maß der Blutdrucksenkung unter Empa gliflozin ist dabei abhängig vom Ausgangswert.…”

Section: Forum Der Industrieunclassified

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SGLT2-Inhibitoren – Effektive Blutzuckerregulation über die Niere

2014

Diabetes aktuell

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Empagliflozin as Add On to Basal Insulin for 78 Weeks Improves Glycemic Control with Weight Loss in Insulin-Treated Type 2 Diabetes (T2DM)

Cited by 34 publications

References 0 publications

Sodium-Glucose Cotransporter 2 Inhibition and Glycemic Control in Type 1 Diabetes: Results of an 8-Week Open-Label Proof-of-Concept Trial

Sodium-Glucose Cotransporter 2 Inhibition and Glycemic Control in Type 1 Diabetes: Results of an 8-Week Open-Label Proof-of-Concept Trial

Improved Glucose Control With Weight Loss, Lower Insulin Doses, and No Increased Hypoglycemia With Empagliflozin Added to Titrated Multiple Daily Injections of Insulin in Obese Inadequately Controlled Type 2 Diabetes

SGLT2-Inhibitoren – Effektive Blutzuckerregulation über die Niere

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