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APIDRA Registration Study

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 4

Locations

Kazakhstan

Study Type

Interventional

Intervention

Insulin Glulisine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

Dynamics НbA1c in the final point compared with the initial level.

Dynamics compared with the initial level of glycemia and insulin dosages.

Secondary Outcome Measures

Evaluation of frequency of glycemia episodes. Also undesirable events, Influence on indexes of general clinical analysis of blood and biochemical analysis of blood.

Full Information

NCT ID

NCT00489190

First Posted

June 20, 2007

Last Updated

March 13, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00489190

Brief Title

APIDRA Registration Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Insulin Glulisine

Primary Outcome Measure Information:

Title

Dynamics НbA1c in the final point compared with the initial level.

Time Frame

end of the study

Title

Dynamics compared with the initial level of glycemia and insulin dosages.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arman UTEGULOV

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Almaty

Country

Kazakhstan

12. IPD Sharing Statement

Learn more about this trial

APIDRA Registration Study

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