Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): a randomised, double-blind, placebo-controlled trial

Dejgaard, Thomas F.; Frandsen, Christian Seerup; Hansen, Thorsten; Almdal, Thomas; Urhammer, Søren A.; Pedersen‐Bjergaard, Ulrik; Jensen, Tonny; Jensen, Andreas Kryger; Holst, Jens J.; Tarnow, Lise; Knop, Filip K.; Madsbad, Sten; Andersen, Henrik U

doi:10.1016/s2213-8587(15)00436-2

Cited by 133 publications

(168 citation statements)

References 25 publications

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“…The latter study also demonstrated reduction in hypoglycemic events (15). Novo Nordisk has withdrawn their intent to seek a regulatory indication for the use of liraglutide in T1D in view of no additional difference in HbA 1c in two large phase-3 trials despite weight loss and reduced insulin doses (16).…”

Section: Discussionmentioning

confidence: 67%

“…A recent 12-week randomized study in normal-weight patients with T1D with 1.2 mg liraglutide and a 24-week randomized study from the same group in overweight and obese patients with poorly controlled T1D with 1.8 mg liraglutide demonstrated significant reduction in body weight and insulin dose without any additional effect on HbA 1c compared with placebo (14,15). The latter study also demonstrated reduction in hypoglycemic events (15).…”

Section: Discussionmentioning

confidence: 99%

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Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks

et al. 2016

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OBJECTIVETo investigate whether addition of three different doses of liraglutide to insulin in patients with type 1 diabetes (T1D) results in significant reduction in glycemia, body weight, and insulin dose.RESEARCH DESIGN AND METHODSWe randomized 72 patients (placebo = 18, liraglutide = 54) with T1D to receive placebo and 0.6, 1.2, and 1.8 mg liraglutide daily for 12 weeks.RESULTSIn the 1.2-mg and 1.8-mg groups, the mean weekly reduction in average blood glucose was −0.55 ± 0.11 mmol/L (10 ± 2 mg/dL) and −0.55 ± 0.05 mmol/L (10 ± 1 mg/dL), respectively (P < 0.0001), while it remained unchanged in the 0.6-mg and placebo groups. In the 1.2-mg group, HbA1c fell significantly (−0.78 ± 15%, −8.5 ± 1.6 mmol/mol, P < 0.01), while it did not in the 1.8-mg group (−0.42 ± 0.15%, −4.6 ± 1.6 mmol/mol, P = 0.39) and 0.6-mg group (−0.26 ± 0.17%, −2.8 ± 1.9 mmol/mol, P = 0.81) vs. the placebo group (−0.3 ± 0.15%, −3.3 ± 1.6 mmol/mol). Glycemic variability was reduced by 5 ± 1% (P < 0.01) in the 1.2-mg group only. Total daily insulin dose fell significantly only in the 1.2-mg and 1.8-mg groups (P < 0.05). There was a 5 ± 1 kg weight loss in the two higher-dose groups (P < 0.05) and by 2.7 ± 0.6 kg (P < 0.01) in the 0.6-mg group vs. none in the placebo group. In the 1.2- and 1.8-mg groups, postprandial plasma glucagon concentration fell by 72 ± 12% and 47 ± 12%, respectively (P < 0.05). Liraglutide led to higher gastrointestinal adverse events (P < 0.05) and ≤1% increases (not significant) in percent time spent in hypoglycemia (<55 mg/dL, 3.05 mmol/L).CONCLUSIONSAddition of 1.2 mg and 1.8 mg liraglutide to insulin over a 12-week period in overweight and obese patients with T1D results in modest reductions of weekly mean glucose levels with significant weight loss, small insulin dose reductions, and frequent gastrointestinal side effects. These findings do not justify the use of liraglutide in all patients with T1D.

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Section: Discussionmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 99%

Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks

et al. 2016

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“…Due to their potential protection of b-cell mass and suppression of glucagon release, glucagon-like peptide 1 (GLP-1) receptor agonists (25) and dipeptidyl peptidase 4 (DPP-4) inhibitors (26) are being studied in patients with type 1 diabetes but are not currently FDA-approved for use in patients with type 1 diabetes.…”

Section: Incretin-based Therapiesmentioning

confidence: 99%

8. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2018

2017

Diabetes Care

632

315

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The American Diabetes Association (ADA) “Standards of Medical Care in Diabetes” includes ADA’s current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA’s clinical practice recommendations, please refer to the Standards of Care Introduction. Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

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“…The administration of liraglutide as an adjunct to insulin has consistently shown a reduction in daily insulin dose and weight loss compared with control subjects, and neutral or positive results in terms of HbA 1c levels and rates of hypoglycemia (6)(7)(8)(9)(10)(11)(12). This study aims to address whether adding liraglutide to insulin therapy in a treat-to-target approach can safely improve glycemic control in a population that is generally representative of people with type 1 diabetes when studied in a randomized, double-blind fashion over a 52-week period.…”

mentioning

confidence: 99%

Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial

et al. 2016

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OBJECTIVETo investigate whether liraglutide added to treat-to-target insulin improves glycemic control and reduces insulin requirements and body weight in subjects with type 1 diabetes. RESEARCH DESIGN AND METHODSA 52-week, double-blind, treat-to-target trial involving 1,398 adults randomized 3:1 to receive once-daily subcutaneous injections of liraglutide (1.8, 1.2, or 0.6 mg) or placebo added to insulin. RESULTSHbA 1c level was reduced 0.34-0.54% (3.7-5.9 mmol/mol) from a mean baseline of 8.2% (66 mmol/mol), and significantly more for liraglutide 1.8 and 1.2 mg compared with placebo (estimated treatment differences [ETDs] CONCLUSIONSLiraglutide added to insulin therapy reduced HbA 1c levels, total insulin dose, and body weight in a population that was generally representative of subjects with type 1 diabetes, accompanied by increased rates of symptomatic hypoglycemia and hyperglycemia with ketosis, thereby limiting clinical use in this group.

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Efficacy and safety of liraglutide for overweight adult patients with type 1 diabetes and insufficient glycaemic control (Lira-1): a randomised, double-blind, placebo-controlled trial

Cited by 133 publications

References 25 publications

Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks

Addition of Liraglutide to Insulin in Patients With Type 1 Diabetes: A Randomized Placebo-Controlled Clinical Trial of 12 Weeks

8. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2018

Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial

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