Abstract | AIMS: 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.
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Authors | N Inagaki, H Watada, M Murai, T Kagimura, Y Gong, S Patel, H-J Woerle |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 15
Issue 9
Pg. 833-43
(Sep 2013)
ISSN: 1463-1326 [Electronic] England |
PMID | 23565760
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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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
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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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