DOMME Dose Optimization Multicentric Mexican Evaluation

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Insulin glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00488527

LANTU_L_01890

Details and patient eligibility

About

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

Enrollment

371 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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