DOMME Dose Optimization Multicentric Mexican Evaluation
DOMME Dose Optimization Multicentric Mexican Evaluation
To evaluate the efficiency of Lantus plus combined oral hypoglycaemic agents in terms of
 respondents percentage. The respondent is defined as the person achieving a value in the
 final determination of HbA1c < 7% as its absolute value and/or a decreasing in the final
 value of HbA1c of more than 12% compared with the initial value (final HbA1c vs. initial
 HbA1c).

 Describe the glycemia levels and body weight change in the two response groups, (respondents
 and non-respondents).

 Describe the adverse events Evaluate the safety of using the medication according to the
 incidence and relevance of the hypoglycemia events, (symptomatic, diurnal, nocturnal,
 severe).

 Estimate the intra-patient variability of the fasting glycemia
Inclusion Criteria:

 -  Patients with type 2 diabetes mellitus receiving antidiabetic treatment (1 or 2 oral
 agents) during more than 6 months, who need a prolonged action basal insulin to
 control hyperglycemia

 -  Glycosylated hemoglobin > 8,0% and < 10 %

 -  Body mass index (BMI) < 40 kg/m2

 -  Voluntary acceptation of the treatment and capability to self inject the insulin
 glargine

 -  Capability and desire to carry out self-determination of glycemia levels using
 glucometers

 Exclusion Criteria:

 -  Renal function disorder, revealed by a serum creatinine > 177 µmol/l (> 2,0 mg/dl) in
 Visit 1 or currently undergoing kidney dialysis

 -  Acute metabolic acidosis (> 1 episode during the last year) or chronic, including
 diabetic ketoacidosis

 -  Clinical evidence of an active liver disease or serum ALT/AST >2.5 times the upper
 normality limit

 -  A history of unnoticed hypoglycemia

 -  Surgical treatment for diabetic retinopathy, (laser photocoagulation or a vitrectomy),
 during the three months prior to joining the trial, or patient that has needed
 treatment within three months of entering the trial

 -  Pregnancy or breast feeding

 -  Not using an adequate birth control method, (only for potentially fertile females) :
 for example, the use of systemic hormones, (pills or birth control implants),
 intrauterine devices or a barrier method, (diaphragm with intra-vaginal spermicides,
 male or female preservative)

 -  Known hypersensitivity to insulin glargine or any of its excipients

 -  Malignant process, except for basal carcinoma cells during the last five years

 -  More than two weeks of continuous treatment with systemic glucocorticoids in the last
 6 months

 -  Concomitant treatment with non-cardio selective beta blockers

 -  Known supra-renal failure

 -  Known hemoglobinopathy or anemia, uncontrolled or unstable

 -  A psychiatric disturbance which prevents the patient from understanding the nature,
 objective and possible consequences of the trial

 -  A history of drug or alcohol abuse in the last two years or any current addiction

 -  Current use of insulin glargine

 -  Any clinically relevant, cardiovascular, hepatic, neurological, endocrinal or systemic
 major disease, or any other type, which may hinder the development of the protocol or
 the interpretation of the results of the trial

 -  Known existence of GAD (glutamic acid decarboxylase) antibodies

 -  Type 1 diabetes mellitus, according to its definition by the WHO

 -  The use of a drug being researched other than insulin during six months prior to
 joining the trial or the use of an insulin under study during four weeks before
 entering the trial

 -  A history of severe hypoglycemia with repeated blackouts, (more than 1), during the
 last year

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.