APIDRA Registration Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00489190
• Date of registration: 20/06/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: APIDRA Registration Study
• Scientific title: Local, Open, Non-Randomized, Phase IV Clinical Study for the Collection of Data Regarding the Drug Portability Received During the Treatment With Subcutaneous Injection of Apidra Glulisine (HMR1964) to Patients With Diabetes Mellitus 1st Type
• Date of first enrolment: August 2005
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00489190
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Kazakhstan

Contacts

• Name: Arman UTEGULOV
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diabetes Mellitus 1st type, with ?bA1c 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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 1

Intervention(s)

Drug: Insulin Glulisine

Primary Outcome(s)

Dynamics ?bA1c in the final point compared with the initial level. [Time Frame: end of the study]

Dynamics compared with the initial level of glycemia and insulin dosages. [Time Frame: 12 weeks]

Secondary Outcome(s)

Evaluation of frequency of glycemia episodes. Also undesirable events, Influence on indexes of general clinical analysis of blood and biochemical analysis of blood. [Time Frame: from the beginning to the end of the study]

Secondary ID(s)

APIDR_L_00041

Source(s) of Monetary Support

Please refer to primary and secondary sponsors