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Linagliptin provides effective, well-tolerated add-on therapy to pre-existing oral antidiabetic therapy over 1 year in Japanese patients with type 2 diabetes.

AbstractAIMS:
To evaluate the long-term safety and efficacy of linagliptin as add-on therapy to one approved oral antidiabetic drug (OAD) in Japanese patients with type 2 diabetes mellitus and insufficient glycaemic control.
METHODS:
This 52-week, multicentre, open-label, parallel-group study evaluated once-daily linagliptin 5 mg as add-on therapy to one OAD [biguanide, glinide, glitazone, sulphonylurea (SU) or α-glucosidase inhibitors (A-GI)] in 618 patients. After a 2-week run-in, patients on SU or A-GI were randomized to either linagliptin (once daily, 5 mg) or metformin (twice or thrice daily, up to 2250 mg/day) as add-on therapy. Patients receiving the other OADs received linagliptin add-on therapy (non-randomized).
RESULTS:
Adverse events were mostly mild or moderate, and rates were similar across all groups. Hypoglycaemic events were rare, except in the SU group. Overall, 26 (5.8%) hypoglycaemic events were reported in patients receiving linagliptin (non-randomized). Hypoglycaemic events were similar for linagliptin and metformin added to A-GI (1/61 vs. 2/61, respectively) or SU (17/124 vs. 10/63, respectively). Significant reductions in glycated haemoglobin (HbA1c) levels (between -0.7 and -0.9%) occurred throughout the study period for the background therapy groups that received linagliptin (baseline HbA1c 7.9-8.1%). The decline in HbA1c levels was indistinguishable between linagliptin and metformin groups when administered as add-on therapy to A-GI or SU.
CONCLUSIONS:
Once-daily linagliptin showed safety and tolerability over 1 year and provided effective add-on therapy leading to significant HbA1c reductions, similar to metformin, over 52 weeks in Japanese patients.
AuthorsN Inagaki, H Watada, M Murai, T Kagimura, Y Gong, S Patel, H-J Woerle
JournalDiabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 15 Issue 9 Pg. 833-43 (Sep 2013) ISSN: 1463-1326 [Electronic] England
PMID23565760 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Copyright© 2013 Blackwell Publishing Ltd.
Chemical References
  • Biguanides
  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Purines
  • Quinazolines
  • Sulfonylurea Compounds
  • Thiazolidinediones
  • hemoglobin A1c protein, human
  • Linagliptin
  • Metformin
Topics
  • Asian People (statistics & numerical data)
  • Biguanides (administration & dosage)
  • Blood Glucose (metabolism)
  • Diabetes Mellitus, Type 2 (blood, drug therapy, epidemiology)
  • Drug Therapy, Combination
  • Female
  • Glycated Hemoglobin (metabolism)
  • Humans
  • Hypoglycemic Agents (administration & dosage)
  • Japan (epidemiology)
  • Linagliptin
  • Male
  • Metformin (administration & dosage)
  • Middle Aged
  • Purines (administration & dosage)
  • Quinazolines (administration & dosage)
  • Sulfonylurea Compounds (administration & dosage)
  • Thiazolidinediones (administration & dosage)
  • Time Factors
  • Treatment Outcome

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