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document
Impact of empagliflozin added on to basal insulin in type 2 diabetes inadequately controlled on basal insulin : a 78-week randomized , double-blind , placebo-controlled trial . AIMS To investigate the efficacy and tolerability of empagliflozin added to basal insulin-treated type 2 diabetes . METHODS Patients inadequately controlled [ glycated haemoglobin ( HbA1c ) > 7 to ≤10 % ( > 53 to ≤86 mmol/mol ) ] on basal insulin ( glargine , detemir , NPH ) were randomized to empagliflozin 10 mg ( n = 169 ) , empagliflozin 25 mg ( n = 155 ) or placebo ( n = 170 ) for 78 weeks . The baseline characteristics were balanced among the groups [ mean HbA1c 8.2 % ( 67 mmol/mol ) , BMI 32.2 kg/m ( 2 ) ] . The basal insulin dose was to remain constant for 18 weeks , then could be adjusted at investigator 's discretion . The primary endpoint was change from baseline in HbA1c at week 18 . Key secondary endpoints were changes from baseline in HbA1c and insulin dose at week 78 . RESULTS At week 18 , the adjusted mean ± standard error changes from baseline in HbA1c were 0.0 ± 0.1 % ( -0.1 ± 0.8 mmol/mol ) for placebo , compared with -0.6 ± 0.1 % ( -6.2 ± 0.8 mmol/mol ) and -0.7 ± 0.1 % ( -7.8 ± 0.8 mmol/mol ) for empagliflozin 10 and 25 mg , respectively ( both p < 0.001 ) . At week 78 , empagliflozin 10 and 25 mg significantly reduced HbA1c , insulin dose and weight vs placebo ( all p < 0.01 ) , and empagliflozin 10 mg significantly reduced systolic blood pressure vs placebo ( p = 0.004 ) . Similar percentages of patients had confirmed hypoglycaemia in all groups ( 35-36 % ) . Events consistent with urinary tract infection were reported in 9 , 15 and 12 % of patients on placebo , empagliflozin 10 and 25 mg , and events consistent with genital infection were reported in 2 , 8 and 5 % , respectively . CONCLUSIONS Empagliflozin for 78 weeks added to basal insulin improved glycaemic control and reduced weight with a similar risk of hypoglycaemia to placebo .
71678
Intervention_Pharmacological
empagliflozin
71679
Intervention_Control
placebo-controlled
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Intervention_Pharmacological
empagliflozin
71681
Intervention_Pharmacological
empagliflozin
71682
Intervention_Pharmacological
empagliflozin
71683
Outcome_Other
efficacy
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Outcome_Other
tolerability
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Participant_Condition
type 2 diabetes
71686
Participant_Sample-size
169
71687
Participant_Sample-size
155
71688
Participant_Sample-size
170