Insulin Glulisine, Diabetes Mellitus Type 1 | NCT00397553

Studies
Insulin Glulisine, Diabetes Mellitus Type 1

NCT00397553

Sponsor

Sanofi

Status

Completed

Last Update Posted

Sep 18, 2009Estimated

Enrollment

104Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin glulisine

Countries

Russia

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

May 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

Jan 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Not provided

First Submitted Date

Nov 8, 2006

First Submission Date that Met QC Criteria

Nov 8, 2006

First Posted Date

Nov 9, 2006Estimated

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

Sep 17, 2009

Last Update Posted Date

Sep 18, 2009Estimated

Description Module

Brief Summary

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Label	Type	Description	Intervention Names
Insulin Glulisine	Experimental		Drug: Insulin glulisine

Name	Type	Description	Arm Group Labels	Other Names
Insulin glulisine	Drug		Insulin Glulisine

Measure	Description	Time Frame
HbA1c		52 weeks

Measure	Description	Time Frame
HbA1c		26 weeks
Fasting Blood Glucose		26 weeks
Fasting Blood Glucose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes mellitus, Type 1
HbA1c 6.5-11.0%
BMI <35 kg/m²

Exclusion Criteria:

Diabetes mellitus, Type 2

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

Name	Affiliation	Role
Marina Atarshchikova, MD	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C479079	insulin glulisine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided