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OpenTrials
Completed

NCT Number: NCT00489190

APIDRA Registration Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Almaty, Kazakhstan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glulisine

Drug

Primary outcomes

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

    Time frame: end of the study

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

    Time frame: 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.

    Time frame: from the beginning to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2005
First posted
Jun 21, 2007
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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