APIDRA Registration Study

Sanofi

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin Glulisine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00489190

APIDR_L_00041

Details and patient eligibility

About

To collect effectiveness and safety data during the treatment with Apidra glulisine (HMR1964) by means of subcutaneous injections to patients with Diabetes Mellitus 1st type during 12 weeks-active phase.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diabetes Mellitus 1st type, with НbA1c level in the range of ≥ 6,5 - <=11%, receiving the regimen of multiple injections of insulin during one year.

Exclusion criteria

Active proliferative diabetic retinopathy connected with focal or panretinal photocoagulation or vitrectomy carried out within 6 months before visit 1, or any unstable (quickly progressive) form of retinopathy, which may need in surgical intervention (including laser photocoagulation) during study
Diabetes Mellitus of the 2nd type
Patients transmitted pancreatectomy
Patients transmitted transplantation of pancreas or islet cells
Probable therapy by means of products not approved by study minutes during the study
Anamnestic indications of convulsive disorders
Allergic reaction on insulin or any filler of preparation Apidra (glulisine)
Clinical serious diseases of cardiovascular system, liver, nervous system, endocrine system, oncologic diseases or other serious system diseases, which complicate keeping of minutes or interpretation of study results, and, at the investigator's opinion, impede the safe participation of patients in study
Drug addiction or alcoholism
Disturbance of liver functions confirmed with the increase of ALT or AST activity up to the level twice as high as the upper standard limit (these indications may not be single)
Disturbance of functions of kidneys confirmed with the level of creatinine in serum that is more than 177 mµmol/l at visit 1 (this indication may not be single)
Pregnancy or breast-feeding