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Liraglutide as add-on therapy to insulin in type 2 diabetes mellitus: a retrospective, observational study from a daily clinical practice setting in Switzerland.

Lipowsky C, Sze L, Krull I, Brändle M - Diabetes Ther (2015)

Bottom Line: Median weight decreased significantly from 99.8 kg (IQR 81-110) at baseline to 97.7 kg (IQR 81.2-108.2, p = 0.027) at 3 months, but rose again thereafter.Insulin dosage did not change significantly over time.No severe hypoglycemia or major side effects occurred.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Diabetes, Department of Internal Medicine, Kantonsspital St. Gallen, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland, christof.lipowsky@gmail.com.

ABSTRACT

Introduction: In most patients with type 2 diabetes mellitus (T2DM) and progressive beta-cell insufficiency, insulin therapy is required to achieve sufficient glycemic control. However, insulin therapy may lead to weight gain and increasing risk of hypoglycemia. Glucagon-like peptide-1 receptor agonists are being used as add-on therapy to insulin with favorable metabolic effects. Nonetheless, to date only few studies exist reporting on the combination of liraglutide and insulin with a short follow-up period. The aim of this study was to evaluate the efficacy and safety of liraglutide as add-on to insulin in patients with T2DM over a time period of up to 24-28 months.

Methods: Data of patients with T2DM, treated with insulin and liraglutide at an outpatient clinic in a tertiary referral hospital from October 2009 until December 2011 were retrospectively examined (n = 36). Glycated hemoglobin (HbA1c), weight, total daily insulin dose and side effects were assessed 5-8 months prior to liraglutide, at baseline and at follow-up visits after 3, 6, 12-16 and 24-28 months.

Results: Median HbA1c decreased significantly from 7.7% [interquartile range (IQR) 7.0-8.6] at baseline to 6.8% (IQR 6.5-7.7, p = 0.001) at 3 months and 6.9% (IQR 6.3-7.6, p = 0.0001) at 6 months, but re-increased thereafter (at 24-28 months, median 7.5%, IQR 7.1-8.2, p = 1.0). Median weight decreased significantly from 99.8 kg (IQR 81-110) at baseline to 97.7 kg (IQR 81.2-108.2, p = 0.027) at 3 months, but rose again thereafter. Insulin dosage did not change significantly over time. No severe hypoglycemia or major side effects occurred.

Conclusions: In this observational study, adding liraglutide to insulin in daily clinical practice reduced HbA1c significantly within 6 months, but there may be a non-sustainable effect during long-term treatment.

No MeSH data available.


Related in: MedlinePlus

Course of glycated hemoglobin (HbA1c), insulin (total units and units per kg body weight), weight and body mass index (BMI) prior (T-1), at baseline (T0) and during follow-up after 3 (T1), 6 (T2), 12–16 (T3) and 24–28 months (T4)
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Fig1: Course of glycated hemoglobin (HbA1c), insulin (total units and units per kg body weight), weight and body mass index (BMI) prior (T-1), at baseline (T0) and during follow-up after 3 (T1), 6 (T2), 12–16 (T3) and 24–28 months (T4)

Mentions: Median HbA1c decreased significantly from 7.7% (IQR 7.0–8.6) at baseline to 6.8% (IQR 6.5–7.7, p = 0.001) at 3 months and 6.9%, (IQR 6.3–7.6, p = 0.0001) at 6 months, but re-increased at 12–16 months (median 7.2%, IQR 6.7–7.9, p = 0.32) and 24–28 months (median 7.5%, IQR 7.1–8.2, p = 1.0). HbA1c prior to intervention was lower (median 7.3%, IQR 7.1–7.9) than at baseline. Weight and BMI decreased significantly from 99.8 kg and 33.5 kg/m2 (IQR 81–110 and 29.4–37.6) respectively at baseline to 97.7 kg and 31.9 kg/m2 (IQR 81.2–108.2 and 29.4–36), (p = 0.023 and 0.027) at 3 months. However weight and BMI increased again after 6 months (median 97.5 kg and 31.5 kg/m2, IQR 84.5.5–111.5, p = 0.16 and 29.4–35.1, p = 0.15), at 12–16 months (100.5 kg and 34.1 kg/m2, IQR 100.5–109.5, p = 0.17 and 30.7–36.7, p = 0.16) and at 24–28 months (106.4 kg and 36.4 kg/m2, IQR 96.9–118, p = 1.0 and 30.9–38.4, p = 1.0). Insulin dosage did not change significantly over time (Fig. 1). However, during follow-up, three patients (10.3%) were able to completely stop insulin therapy, and two patients (6.9%) could simplify their multiple daily insulin injection regimens to basal insulin at bedtime only. Furthermore, sulfonylureas were stopped in 5 of 12 patients (41.7%) and all other antidiabetic drugs beside metformin were stopped (e.g. glitazones, glinides). No severe hypoglycemia occurred over the entire period. Overall, 5 patients (15.6%) out of 32 followed-up patients discontinued liraglutide due to side effects. Three patients stopped liraglutide due to exanthema at the injection site, nausea or abdominal pain at the beginning and two patients discontinued liraglutide due to nausea/vomiting and pain at the injection site after 3.5 and 12 months.Fig. 1


Liraglutide as add-on therapy to insulin in type 2 diabetes mellitus: a retrospective, observational study from a daily clinical practice setting in Switzerland.

Lipowsky C, Sze L, Krull I, Brändle M - Diabetes Ther (2015)

Course of glycated hemoglobin (HbA1c), insulin (total units and units per kg body weight), weight and body mass index (BMI) prior (T-1), at baseline (T0) and during follow-up after 3 (T1), 6 (T2), 12–16 (T3) and 24–28 months (T4)
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4374072&req=5

Fig1: Course of glycated hemoglobin (HbA1c), insulin (total units and units per kg body weight), weight and body mass index (BMI) prior (T-1), at baseline (T0) and during follow-up after 3 (T1), 6 (T2), 12–16 (T3) and 24–28 months (T4)
Mentions: Median HbA1c decreased significantly from 7.7% (IQR 7.0–8.6) at baseline to 6.8% (IQR 6.5–7.7, p = 0.001) at 3 months and 6.9%, (IQR 6.3–7.6, p = 0.0001) at 6 months, but re-increased at 12–16 months (median 7.2%, IQR 6.7–7.9, p = 0.32) and 24–28 months (median 7.5%, IQR 7.1–8.2, p = 1.0). HbA1c prior to intervention was lower (median 7.3%, IQR 7.1–7.9) than at baseline. Weight and BMI decreased significantly from 99.8 kg and 33.5 kg/m2 (IQR 81–110 and 29.4–37.6) respectively at baseline to 97.7 kg and 31.9 kg/m2 (IQR 81.2–108.2 and 29.4–36), (p = 0.023 and 0.027) at 3 months. However weight and BMI increased again after 6 months (median 97.5 kg and 31.5 kg/m2, IQR 84.5.5–111.5, p = 0.16 and 29.4–35.1, p = 0.15), at 12–16 months (100.5 kg and 34.1 kg/m2, IQR 100.5–109.5, p = 0.17 and 30.7–36.7, p = 0.16) and at 24–28 months (106.4 kg and 36.4 kg/m2, IQR 96.9–118, p = 1.0 and 30.9–38.4, p = 1.0). Insulin dosage did not change significantly over time (Fig. 1). However, during follow-up, three patients (10.3%) were able to completely stop insulin therapy, and two patients (6.9%) could simplify their multiple daily insulin injection regimens to basal insulin at bedtime only. Furthermore, sulfonylureas were stopped in 5 of 12 patients (41.7%) and all other antidiabetic drugs beside metformin were stopped (e.g. glitazones, glinides). No severe hypoglycemia occurred over the entire period. Overall, 5 patients (15.6%) out of 32 followed-up patients discontinued liraglutide due to side effects. Three patients stopped liraglutide due to exanthema at the injection site, nausea or abdominal pain at the beginning and two patients discontinued liraglutide due to nausea/vomiting and pain at the injection site after 3.5 and 12 months.Fig. 1

Bottom Line: Median weight decreased significantly from 99.8 kg (IQR 81-110) at baseline to 97.7 kg (IQR 81.2-108.2, p = 0.027) at 3 months, but rose again thereafter.Insulin dosage did not change significantly over time.No severe hypoglycemia or major side effects occurred.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Diabetes, Department of Internal Medicine, Kantonsspital St. Gallen, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland, christof.lipowsky@gmail.com.

ABSTRACT

Introduction: In most patients with type 2 diabetes mellitus (T2DM) and progressive beta-cell insufficiency, insulin therapy is required to achieve sufficient glycemic control. However, insulin therapy may lead to weight gain and increasing risk of hypoglycemia. Glucagon-like peptide-1 receptor agonists are being used as add-on therapy to insulin with favorable metabolic effects. Nonetheless, to date only few studies exist reporting on the combination of liraglutide and insulin with a short follow-up period. The aim of this study was to evaluate the efficacy and safety of liraglutide as add-on to insulin in patients with T2DM over a time period of up to 24-28 months.

Methods: Data of patients with T2DM, treated with insulin and liraglutide at an outpatient clinic in a tertiary referral hospital from October 2009 until December 2011 were retrospectively examined (n = 36). Glycated hemoglobin (HbA1c), weight, total daily insulin dose and side effects were assessed 5-8 months prior to liraglutide, at baseline and at follow-up visits after 3, 6, 12-16 and 24-28 months.

Results: Median HbA1c decreased significantly from 7.7% [interquartile range (IQR) 7.0-8.6] at baseline to 6.8% (IQR 6.5-7.7, p = 0.001) at 3 months and 6.9% (IQR 6.3-7.6, p = 0.0001) at 6 months, but re-increased thereafter (at 24-28 months, median 7.5%, IQR 7.1-8.2, p = 1.0). Median weight decreased significantly from 99.8 kg (IQR 81-110) at baseline to 97.7 kg (IQR 81.2-108.2, p = 0.027) at 3 months, but rose again thereafter. Insulin dosage did not change significantly over time. No severe hypoglycemia or major side effects occurred.

Conclusions: In this observational study, adding liraglutide to insulin in daily clinical practice reduced HbA1c significantly within 6 months, but there may be a non-sustainable effect during long-term treatment.

No MeSH data available.


Related in: MedlinePlus