A randomized controlled trial of the efficacy and safety of saxagliptin as add-on therapy in patients with type 2 diabetes and inadequate glycaemic control on metformin plus a sulphonylurea.

Abstract

AIMS:

To evaluate the efficacy and safety of saxagliptin as add-on therapy in adults with type 2 diabetes with inadequate glycaemic control on metformin plus a sulphonylurea.

METHODS:

In this 24-week, multicentre, randomized, parallel-group, double-blind study, outpatients aged ≥18 years with type 2 diabetes, body mass index ≤40 kg/m(2) and inadequate glycaemic control, received saxagliptin 5 mg or placebo once-daily added to background medication consisting of a stable maximum tolerated dose of metformin plus a sulphonylurea. The primary end point was change in glycated haemoglobin (HbA1c) from baseline to week 24. Safety and tolerability assessments included adverse events (AEs), hypoglycaemia and body weight.

RESULTS:

A total of 257 patients were randomized, treated and included in the safety analysis (saxagliptin, n = 129; placebo, n = 128); 255 were included in the efficacy analysis (saxagliptin, n = 127; placebo, n = 128). HbA1c reduction was greater with saxagliptin versus placebo [between-group difference in adjusted mean change from baseline, -0.66%; 95% confidence interval (CI), -0.86 to -0.47 (7 mmol/mol, -9.4 to -5.1); p < 0.0001]. The proportion of patients with ≥1 AE was 62.8% with saxagliptin and 71.7% with placebo. In the saxagliptin and placebo groups, rates of reported hypoglycaemia were 10.1 and 6.3%, respectively, and rates of confirmed hypoglycaemia (symptoms + glucose < 2.8 mmol/l) were 1.6 and 0%. Mean change in body weight was 0.2 kg for saxagliptin and -0.6 kg for placebo (p = 0.0272).

CONCLUSION:

Addition of saxagliptin 5 mg/day in patients inadequately controlled on metformin and sulphonylurea effectively improved glycaemic control and was well tolerated.

• Authors: R G Moses, S Kalra, D Brook, J Sockler, J Monyak, J Visvanathan, M Montanaro, S A Fisher
• Journal: Diabetes, obesity & metabolism (Diabetes Obes Metab) Vol. 16 Issue 5 Pg. 443-50 (May 2014) ISSN: 1463-1326 [Electronic] England
• PMID: 24205943 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2013 John Wiley & Sons Ltd.

Chemical References

• Blood Glucose
• Dipeptides
• Dipeptidyl-Peptidase IV Inhibitors
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Sulfonylurea Compounds
• hemoglobin A1c protein, human
• Metformin
• saxagliptin
• Adamantane

Topics

• Adamantane (administration & dosage, adverse effects, analogs & derivatives)
• Adult
• Australia (epidemiology)
• Blood Glucose (drug effects, metabolism)
• Body Mass Index
• Body Weight (drug effects)
• Canada (epidemiology)
• Diabetes Mellitus, Type 2 (blood, drug therapy, epidemiology)
• Dipeptides (administration & dosage, adverse effects)
• Dipeptidyl-Peptidase IV Inhibitors (administration & dosage)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Glycated Hemoglobin (drug effects, metabolism)
• Humans
• Hypoglycemia (blood, drug therapy, epidemiology)
• Hypoglycemic Agents (administration & dosage, adverse effects, therapeutic use)
• India (epidemiology)
• Korea (epidemiology)
• Male
• Metformin (administration & dosage)
• Middle Aged
• Sulfonylurea Compounds (administration & dosage)
• Thailand (epidemiology)
• Treatment Outcome
• United Kingdom