APIDRA Registration Study

Diabetes Mellitus, Type 1 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489190
• Other study ID #: APIDR_L_00041
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2007
• Last updated: March 13, 2009
• Start date: August 2005

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kazakhstan : National center of pharmacoexperts
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin Glulisine

Locations

Country	Name	City	State
Kazakhstan	Sanofi-Aventis	Almaty

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamics ?bA1c in the final point compared with the initial level.		end of the study
Primary	Dynamics compared with the initial level of glycemia and insulin dosages.		12 weeks
Secondary	Evaluation of frequency of glycemia episodes. Also undesirable events, Influence on indexes of general clinical analysis of blood and biochemical analysis of blood.		from the beginning to the end of the study