Abstract | AIM: 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.
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Authors | Burkhard Göke, Baptist Gallwitz, Johan G Eriksson, Åsa Hellqvist, Ingrid Gause-Nilsson |
Journal | International journal of clinical practice
(Int J Clin Pract)
Vol. 67
Issue 4
Pg. 307-16
(Apr 2013)
ISSN: 1742-1241 [Electronic] India |
PMID | 23638466
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Dipeptides
- Dipeptidyl-Peptidase IV Inhibitors
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Metformin
- saxagliptin
- Adamantane
- Glipizide
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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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