Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study | NCT00539448

Studies
Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study

NCT00539448

Sponsor

Sanofi

Status

Completed

Last Update Posted

Sep 25, 2009Estimated

Enrollment

98Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glargine
insulin glulisine

Countries

Bahrain
Kuwait
Qatar
United Arab Emirates

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

Sep 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

Apr 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 3, 2007

First Submission Date that Met QC Criteria

Oct 3, 2007

First Posted Date

Oct 4, 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

Sep 24, 2009

Last Update Posted Date

Sep 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary objective :

To evaluate the efficacy (in terms of change in HbA1c readings starting from baseline then after 13 weeks & at the end of the study which will be after 26 weeks) in subjects with type I diabetes mellitus.

Secondary objective :

Recording the average daily dose of both insulin Glulisine & insulin Glargine in type I DM.
Recording adverse events.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	combination of insulin Glargine & insulin Glulisine as basal bolus regimen	Drug: insulin glargine Drug: insulin glulisine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin glargine	Drug	in combination with insulin Glulisine as bolus regimen	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluating the Glycemic control of the regimen : Change in A1C levels		from baseline to study end

Secondary Outcomes

Measure	Description	Time Frame
Average daily dose : - For both insulin Glulisine & insulin Glargine. - FBG and PPBG if possible ?		from baseline to study end

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed type I diabetic patients
Type I diabetes treated with basal-bolus regimen including 3 or more injections of Regular Human Insulin per day
BMI, 26-40 kg/m2
HbA1c, 7.5%-10%
Median 2Hrs post -prandial more than or equal to 140 mg/dl (more than or equal to 7.8 mmol/L)
FPG more than or equal to 120 mg/dl (more than or equal to 6.7 mmol/L)
Willingness to accept, and ability to inject insulin Glargine therapy

Exclusion Criteria:

Pregnancy : The use of LANTUS & APIDRA during pregnancy is not contraindicated. However, in the absence of supportive data, Sanofi- Aventis Pharmaceuticals cannot specifically recommend the use of Lantus in this patient population

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

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hisham - MAHMOUD, MD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-aventis administrative office		Manama			Bahrain
Sanofi-aventis administrative office

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
D000069036	Insulin Glargine
C479079	insulin glulisine

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided