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Linagliptin treatment in subjects with type 2 diabetes with and without mild-to-moderate renal impairment.

Groop PH, Del Prato S, Taskinen MR, Owens DR, Gong Y, Crowe S, Patel S, von Eynatten M, Woerle HJ - Diabetes Obes Metab (2014)

Bottom Line: In linagliptin-treated subjects, overall adverse event (AE) rates and serious AE rates were similar to placebo.The incidence of hypoglycaemia with linagliptin and placebo was 11.1 versus 6.9%, 11.9 versus 9.0% and 15.9 versus 12.0% in the normal, mild RI and moderate RI categories, respectively.This pooled analysis provides evidence that linagliptin is an effective, well-tolerated and convenient treatment in subjects with T2DM and mild or moderate RI.

View Article: PubMed Central - PubMed

Affiliation: Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland; Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland; Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia.

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Adjusted mean change from baseline in HbA1c following treatment with linagliptin 5 mg or placebo after 24 weeks (FAS – LOCF). Model includes continuous baseline HbA1c, baseline body mass index (category), washout period, treatment, study, age group, gender, time since diagnosis of diabetes, race, renal function (MDRD) and treatment × renal function (MDRD). CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; s.e., standard error.
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fig01: Adjusted mean change from baseline in HbA1c following treatment with linagliptin 5 mg or placebo after 24 weeks (FAS – LOCF). Model includes continuous baseline HbA1c, baseline body mass index (category), washout period, treatment, study, age group, gender, time since diagnosis of diabetes, race, renal function (MDRD) and treatment × renal function (MDRD). CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; s.e., standard error.

Mentions: Linagliptin was superior to placebo in reducing HbA1c in all renal function categories (Figure 1). After 24 weeks of treatment, the placebo-corrected adjusted mean [95% confidence interval (CI)] changes in HbA1c from baseline in the normal, mild RI and moderate RI categories were −0.63% (−0.73, −0.53; p < 0.0001), −0.67% (−0.80, −0.54; p < 0.0001) and −0.53% (−0.91, −0.14; p < 0.01), respectively. There was no inter-group difference (p-value for interaction = 0.74). Linagliptin treatment resulted in a greater reduction in FPG levels compared with placebo. After 24 weeks, the placebo-corrected adjusted mean (95% CI) changes in FPG from baseline in the normal and mild RI categories were −0.9 mmol/l (−1.1, −0.6) [−16.0 mg/dl (−20.7, −11.4); p < 0.0001] and −1.2 mmol/l (−1.5, −0.9) [−22.0 mg/dl (−27.8, −16.2); p < 0.0001], respectively. The FPG change in the moderate RI category was not statistically significant [−0.3 mmol/l (−1.2, 0.6); −5.5 mg/dl (−22.1, 11.1); p = 0.52], which may be because of the comparatively small number of subjects in this group (n = 92). Overall, for FPG change from baseline, there was a trend toward a treatment effect modification by renal function category (p = 0.096), partially driven by the low number of subjects in the moderate RI category.


Linagliptin treatment in subjects with type 2 diabetes with and without mild-to-moderate renal impairment.

Groop PH, Del Prato S, Taskinen MR, Owens DR, Gong Y, Crowe S, Patel S, von Eynatten M, Woerle HJ - Diabetes Obes Metab (2014)

Adjusted mean change from baseline in HbA1c following treatment with linagliptin 5 mg or placebo after 24 weeks (FAS – LOCF). Model includes continuous baseline HbA1c, baseline body mass index (category), washout period, treatment, study, age group, gender, time since diagnosis of diabetes, race, renal function (MDRD) and treatment × renal function (MDRD). CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; s.e., standard error.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4288982&req=5

fig01: Adjusted mean change from baseline in HbA1c following treatment with linagliptin 5 mg or placebo after 24 weeks (FAS – LOCF). Model includes continuous baseline HbA1c, baseline body mass index (category), washout period, treatment, study, age group, gender, time since diagnosis of diabetes, race, renal function (MDRD) and treatment × renal function (MDRD). CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; s.e., standard error.
Mentions: Linagliptin was superior to placebo in reducing HbA1c in all renal function categories (Figure 1). After 24 weeks of treatment, the placebo-corrected adjusted mean [95% confidence interval (CI)] changes in HbA1c from baseline in the normal, mild RI and moderate RI categories were −0.63% (−0.73, −0.53; p < 0.0001), −0.67% (−0.80, −0.54; p < 0.0001) and −0.53% (−0.91, −0.14; p < 0.01), respectively. There was no inter-group difference (p-value for interaction = 0.74). Linagliptin treatment resulted in a greater reduction in FPG levels compared with placebo. After 24 weeks, the placebo-corrected adjusted mean (95% CI) changes in FPG from baseline in the normal and mild RI categories were −0.9 mmol/l (−1.1, −0.6) [−16.0 mg/dl (−20.7, −11.4); p < 0.0001] and −1.2 mmol/l (−1.5, −0.9) [−22.0 mg/dl (−27.8, −16.2); p < 0.0001], respectively. The FPG change in the moderate RI category was not statistically significant [−0.3 mmol/l (−1.2, 0.6); −5.5 mg/dl (−22.1, 11.1); p = 0.52], which may be because of the comparatively small number of subjects in this group (n = 92). Overall, for FPG change from baseline, there was a trend toward a treatment effect modification by renal function category (p = 0.096), partially driven by the low number of subjects in the moderate RI category.

Bottom Line: In linagliptin-treated subjects, overall adverse event (AE) rates and serious AE rates were similar to placebo.The incidence of hypoglycaemia with linagliptin and placebo was 11.1 versus 6.9%, 11.9 versus 9.0% and 15.9 versus 12.0% in the normal, mild RI and moderate RI categories, respectively.This pooled analysis provides evidence that linagliptin is an effective, well-tolerated and convenient treatment in subjects with T2DM and mild or moderate RI.

View Article: PubMed Central - PubMed

Affiliation: Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland; Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland; Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia.

Show MeSH
Related in: MedlinePlus