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Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial.

AbstractAIM:
To compare the long-term safety, tolerability and efficacy of saxagliptin vs. glipizide as add-on therapy to metformin.
METHODS:
Adults with glycated haemoglobin (HbA1c) > 6.5-10% (on stable metformin ≥ 1500 mg/day) were randomised to saxagliptin 5 mg/day (n = 428) or glipizide titrated from 5 to 20 mg/day (mean dose 15 mg/day; n = 430) for 52 weeks with a 52-week extension (NCT00575588). Assessment of the long-term safety, tolerability and efficacy of add-on saxagliptin vs. glipizide after 104 weeks was a tertiary objective of the initial 52-week study.
RESULTS:
Saxagliptin was well tolerated during the 104-week period; 67.1% of patients receiving saxagliptin vs. 72.6% receiving glipizide had ≥ 1 adverse event (AE), and few patients (4.9% vs. 5.6%) discontinued owing to AEs. Fewer patients treated with saxagliptin experienced hypoglycaemia (3.5% vs. 38.4% with glipizide; difference, -34.9%, 95% CI, -39.8 to -30.0) or confirmed hypoglycaemia (0 vs. 9.1% with glipizide). Weight loss was observed with saxagliptin (-1.5 kg) vs. weight gain with glipizide (+1.3 kg; between-group difference, -2.8 kg, 95% CI, -3.32 kg to -2.20 kg). Change from baseline in HbA1c was -0.41 ± 0.04% with saxagliptin and -0.35 ± 0.04% with glipizide (between-group difference, -0.05%, 95% CI, -0.17 to 0.06%). A post hoc analysis showed that the proportion of patients with baseline HbA1c ≥ 7% who achieved HbA1c < 7% (observed data) at week 104 was 23.1% for saxagliptin + metformin and 22.7% for glipizide + metformin.
DISCUSSION AND CONCLUSION:
A lower risk of hypoglycaemia and reduced body weight were observed with saxagliptin vs. glipizide. No other clinically significant differences were observed between groups in safety profile. No significant between-group differences were observed for reductions in glycaemic parameters. After week 24, a smaller weekly rise in HbA1c was observed with saxagliptin vs. glipizide as add-on therapy to metformin.
AuthorsBurkhard Göke, Baptist Gallwitz, Johan G Eriksson, Åsa Hellqvist, Ingrid Gause-Nilsson
JournalInternational journal of clinical practice (Int J Clin Pract) Vol. 67 Issue 4 Pg. 307-16 (Apr 2013) ISSN: 1742-1241 [Electronic] India
PMID23638466 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Blood Glucose
  • Dipeptides
  • Dipeptidyl-Peptidase IV Inhibitors
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Metformin
  • saxagliptin
  • Adamantane
  • Glipizide
Topics
  • Adamantane (administration & dosage, adverse effects, analogs & derivatives)
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose (drug effects)
  • Diabetes Mellitus, Type 2 (blood, prevention & control)
  • Dipeptides (administration & dosage, adverse effects)
  • Dipeptidyl-Peptidase IV Inhibitors (administration & dosage, adverse effects)
  • Drug Therapy, Combination
  • Female
  • Glipizide (administration & dosage, adverse effects)
  • Glycated Hemoglobin (drug effects)
  • Humans
  • Hypoglycemia (chemically induced)
  • Hypoglycemic Agents (administration & dosage, adverse effects)
  • Male
  • Metformin (administration & dosage, adverse effects)
  • Middle Aged
  • Treatment Outcome

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