One‐year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26‐week extension to a 26‐week main trial

Abstract

AimsTo confirm, in a 26‐week extension study, the sustained efficacy and safety of a fixed combination of insulin degludec and liraglutide (IDegLira) compared with either insulin degludec or liraglutide alone, in patients with type 2 diabetes.MethodsInsulin‐naïve adults with type 2 diabetes randomized to once‐daily IDegLira, insulin degludec or liraglutide, in addition to metformin ± pioglitazone, continued their allocated treatment in this preplanned 26‐week extension of the DUAL I trial.ResultsA total of 78.8% of patients (1311/1663) continued into the extension phase. The mean glycated haemoglobin (HbA1c) concentration at 52 weeks was reduced from baseline by 1.84% (20.2 mmol/mol) for the IDegLira group, 1.40% (15.3 mmol/mol) for the insulin degludec group and 1.21% (13.2 mmol/mol) for the liraglutide group. Of the patients on IDegLira, 78% achieved an HbA1c of <7% (53 mmol/mol) versus 63% of the patients on insulin degludec and 57% of those on liraglutide. The mean fasting plasma glucose concentration at the end of the trial was similar for IDegLira (5.7 mmol/l) and insulin degludec (6.0 mmol/l), but higher for liraglutide (7.3 mmol/l). At 52 weeks, the daily insulin dose was 37% lower with IDegLira (39 units) than with insulin degludec (62 units). IDegLira was associated with a significantly greater decrease in body weight (estimated treatment difference, −2.80 kg, p < 0.0001) and a 37% lower rate of hypoglycaemia compared with insulin degludec. Overall, all treatments were well tolerated and no new adverse events or tolerability issues were observed for IDegLira.ConclusionsThese 12‐month data, derived from a 26‐week extension of the DUAL I trial, confirm the initial 26‐week main phase results and the sustainability of the benefits of IDegLira compared with its components in glycaemic efficacy, safety and tolerability.

The Clinical Impact of GLP-1 Receptor Agonists in Type 2 Diabetes: Focus on the Long-Acting Analogs

“…[17][18][19][20][21][22] In a 52-week comparison of IDegLira with insulin degludec or liraglutide alone, 22 the mean HbA 1c at 52 weeks was reduced by 1.84% in the IDegLira group, 1.40% in the insulin degludec group, and 1.21% in the liraglutide group. Seventy-eight percent of the patients on IDegLira achieved an HbA 1c of <7% compared with 63% of patients receiving insulin degludec and 57% of those receiving liraglutide.…”

“…IDegLira was associated with a greater decrease in body weight of 2.8 kg, and a 37% lower rate of hypoglycemia compared with insulin degludec. 22 …”

A review of the efficacy and safety of the finished fixed-ratio combination of insulin degludec and liraglutide in the treatment of type 2 diabetes mellitus

“…Терапевтическая эффективность ИДегЛира в качестве дополнительной терапии при неэффективности перо-ральных сахароснижающих препаратов или других аго-нистов рецепторов ГПП-1 или базального инсулина изу-чалась в ходе 7 клинических рандомизированных муль-тинациональных исследований III фазы: DUAL-I [11], -II [6], -III [19], -IV [26], -V [18], -VI [14], -VII [5], а также в течение 26 недель продления исследования DUAL-I [12].…”

“…В фазе продления исследования DUAL-I до 52 недель эффективность фиксированной комбинации ИДегЛира в отношении гликемического контроля и снижения массы тела сохранялась [12]. При этом доза инсулина деглудек была увеличена в среднем до 62 ЕД, тогда как доза инсулина деглудек в составе фиксированной комбина-ции с лираглутидом возросла лишь на 39 ЕД и была на 37% меньше.…”

“…Гастроинтестинальные симптомы (тош-нота, диарея, рвота и снижение аппетита) значительно реже возникали в группе ИДегЛира, чем в группе лира-глутида в исследовании DUAL-I и его продлении (рис.) [12]. Однако ни в одном случае наличие и выраженность гастроинтестинальных нежелательных явлений не при-вело к отказу от назначенной терапии и продолжения участия в исследовании.…”