APIDRA Registration Study
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
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 21, 2007
CompletedMarch 16, 2009
March 1, 2009
June 20, 2007
March 13, 2009
Conditions
Outcome Measures
Primary Outcomes (2)
Dynamics НbA1c in the final point compared with the initial level.
end of the study
Dynamics compared with the initial level of glycemia and insulin dosages.
12 weeks
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis
Almaty, Kazakhstan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Arman UTEGULOV
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 21, 2007
Study Start
August 1, 2005
Last Updated
March 16, 2009
Record last verified: 2009-03