Abstract | AIM: METHODS: This was a multicenter, randomized, open-label trial conducted in 45 centres in the USA. A total of 716 patients with type 2 diabetes and glycated haemoglobin A(1c) (HbA(1c) ) ≥ 7.5% and ≤10.0% were screened; 345 were randomized and 322 comprised the intent-to-treat group (premeal, 163; postmeal, 159). Insulin glargine once daily, ±metformin and subcutaneous injections of premeal or postmeal insulin glulisine were given for 52 weeks. Main outcome measures included changes in HbA(1c) , fasting plasma glucose and weight from study baseline to endpoint (week 52). RESULTS: At study end, insulin glulisine achieved similar glycaemic control whether it was administered before or after meals (HbA(1c) : 7.04% premeal vs. 7.16% postmeal, p = NS). Overall hypoglycaemia incidence and severe hypoglycaemia rates were not significantly different between premeal and postmeal groups; however, symptomatic and nocturnal hypoglycaemia rates were higher in the postprandial group. Mean body weight was lower in the postmeal group, with the difference between postmeal and premeal weight change from baseline to week 52 of -0.87 kg (p = 0.243). CONCLUSION: Postprandial glulisine administration provided similar glycaemic control and was non-inferior to preprandial administration on weight gain, without additional risk of severe hypoglycaemia, showing dosing flexibility and the feasibility of such approach when clinically indicated.
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Authors | R Ratner, A Wynne, S Nakhle, O Brusco, A Vlajnic, M Rendell |
Journal | Diabetes, obesity & metabolism
(Diabetes Obes Metab)
Vol. 13
Issue 12
Pg. 1142-8
(Dec 2011)
ISSN: 1463-1326 [Electronic] England |
PMID | 21812890
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2011 Blackwell Publishing Ltd. |
Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- hemoglobin A1c protein, human
- insulin glulisine
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Topics |
- Blood Glucose
(drug effects, metabolism)
- Diabetes Mellitus, Type 2
(drug therapy, metabolism)
- Drug Administration Schedule
- Female
- Glycated Hemoglobin
(drug effects)
- Humans
- Hypoglycemic Agents
(administration & dosage, therapeutic use)
- Insulin
(administration & dosage, analogs & derivatives, therapeutic use)
- Male
- Middle Aged
- Postprandial Period
- Treatment Outcome
- Weight Gain
(drug effects)
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