APIDRA Registration Study | NCT00489190

Studies
APIDRA Registration Study

NCT00489190

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

45Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glulisine

Countries

Kazakhstan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 20, 2007

First Submission Date that Met QC Criteria

Jun 20, 2007

First Posted Date

Jun 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2009

Last Update Posted Date

Mar 16, 2009Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Name	Type	Description	Arm Group Labels	Other Names
Insulin Glulisine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases