Objective: The purpose of DIAMETRE (D/abete et Amarel en Monotherapie, Etud
e de Titration pour la definition des Repondeurs) was to identify factors p
redictive of response to glimepiride monotherapy in type 2 diabetic patient
s in the setting of a prospective multicentre open study.
Material and methods: Patients aged 35-70 years with poorly controlled diab
etes [fasting plasma glucose (FPG) greater than or equal to 1,40 g/l and <
3 g/l at baseline] were treated with glimepiride for 6 months, with dosage
titrated from 1-6 mg daily, depending on the monthly FPG measurement. Respo
nders were defined as patients with a) FPG < 7.78 mmol/l (1.40 g/l) and HbA
(1c) < 7.5% at endpoint, or b) decrease in FPG greater than or equal to 20%
and/or HbA(1c) greater than or equal to 10%. Stepwise logistic regression
analysis was used to identify factors predictive of response.
Results: Of 849 patients evaluable for efficacy, 483 (56.9%) were responder
s. The response was independently influenced by prior treatment with OADs [
OR: 0.399 (0.290-0.549), p = 0.0001] and diabetes duration [OR: 0.912 (0.87
7-0.948), p = 0.0001]. Ninety patients (9.2%) experienced 124 episodes of s
ymptomatic hypoglycaemia. Multivariate analysis revealed that a high level
of HbA(1c) decreased the risk of symptomatic hypoglycaemia [OR: 0.734 (0.62
8; 0.858), p = 0.0001] whereas a family history of type 2 diabetes doubled
this risk [OR: 1.956 (1.246; 3.072), p = 0.003].
Conclusion: This large-scale study, conducted under conditions approximatin
g to current medical practice, confirms that glimepiride has a favourable r
isk-benefit ratio in type 2 diabetes mellitus. Diabetes duration and previo
us treatment with OADs reduced the likelihood of being a responder to treat
ment.