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APIDRA Registration Study

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00489190
First received: June 20, 2007
Last updated: March 13, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Insulin Glulisine
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dynamics НbA1c 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 Measures:
  • 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 ]

Enrollment: 45
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489190

Locations
Kazakhstan
Sanofi-Aventis
Almaty, Kazakhstan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Arman UTEGULOV Sanofi
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00489190     History of Changes
Other Study ID Numbers: APIDR_L_00041
Study First Received: June 20, 2007
Last Updated: March 13, 2009
Health Authority: Kazakhstan : National center of pharmacoexperts

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013