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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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Subgroup analysis of placebo-corrected adjusted mean change in HbA1c from baseline after 24 weeks in subjects with mild and moderate RI (FAS – LOCF). *Subjects with mild or moderate RI (MDRD categorisation) at baseline were pooled in this analysis. †p-value for interaction between treatment and subgroup category. Model includes continuous baseline HbA1c, washout period, treatment, study, variable of interest and treatment × variable of interest. BMI, body mass index; CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; RI, renal impairment; UACR, urine albumin-to-creatinine ratio.
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fig02: Subgroup analysis of placebo-corrected adjusted mean change in HbA1c from baseline after 24 weeks in subjects with mild and moderate RI (FAS – LOCF). *Subjects with mild or moderate RI (MDRD categorisation) at baseline were pooled in this analysis. †p-value for interaction between treatment and subgroup category. Model includes continuous baseline HbA1c, washout period, treatment, study, variable of interest and treatment × variable of interest. BMI, body mass index; CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; RI, renal impairment; UACR, urine albumin-to-creatinine ratio.

Mentions: In subjects with any renal dysfunction (i.e. mild and moderate RI categories combined), significant and comparable reductions from baseline at week 24 in HbA1c were observed within each subgroup analysed (Figure 2).


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)

Subgroup analysis of placebo-corrected adjusted mean change in HbA1c from baseline after 24 weeks in subjects with mild and moderate RI (FAS – LOCF). *Subjects with mild or moderate RI (MDRD categorisation) at baseline were pooled in this analysis. †p-value for interaction between treatment and subgroup category. Model includes continuous baseline HbA1c, washout period, treatment, study, variable of interest and treatment × variable of interest. BMI, body mass index; CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; RI, renal impairment; UACR, urine albumin-to-creatinine ratio.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig02: Subgroup analysis of placebo-corrected adjusted mean change in HbA1c from baseline after 24 weeks in subjects with mild and moderate RI (FAS – LOCF). *Subjects with mild or moderate RI (MDRD categorisation) at baseline were pooled in this analysis. †p-value for interaction between treatment and subgroup category. Model includes continuous baseline HbA1c, washout period, treatment, study, variable of interest and treatment × variable of interest. BMI, body mass index; CI, confidence interval; FAS, full analysis set; HbA1c, glycated haemoglobin; LOCF, last observation carried forward; MDRD, modification of diet in renal disease; RI, renal impairment; UACR, urine albumin-to-creatinine ratio.
Mentions: In subjects with any renal dysfunction (i.e. mild and moderate RI categories combined), significant and comparable reductions from baseline at week 24 in HbA1c were observed within each subgroup analysed (Figure 2).

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