Assessment of Insulin Glargine in Type 2 Patients for Goo... | NCT00701831

Studies
Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control

NCT00701831

Sponsor

Sanofi

Status

Completed

Last Update Posted

Nov 4, 2010Estimated

Enrollment

241Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin glargine

Countries

Turkey (Türkiye)

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

Nov 2010

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

May 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 18, 2008

First Submission Date that Met QC Criteria

Jun 18, 2008

First Posted Date

Jun 19, 2008Estimated

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

Nov 3, 2010

Last Update Posted Date

Nov 4, 2010Estimated

Description Module

Brief Summary

Primary objective:

To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients

Secondary objectives:

To assess the forced titration on physician and patient satisfaction
To evaluate the impact of training tools by means of patient profile

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

241Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Insulin glargine	Drug: Insulin glargine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin glargine	Drug	The dose is titrated according to patient needs	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c, FBG		after treatment end (6 months)
Final dose		after treatment end (6 months)
Number of dose adjustment		after treatment end (6 months)
Time to dose titration		after treatment end (6 months)

Secondary Outcomes

Measure	Description	Time Frame
Hypoglycemia		after treatment end (6 months)
Noctural hypoglycemia		after treatment end (6 months)
DTSQ

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

T2 insulin naïve patients
Patients whom their physician is considering initiation of Lantus treatment
Poor glycemic control 7,5 %10 %
T2 treatment with OADs more than 3 months
BMI<40 kg/m2

Exclusion Criteria:

Impaired renal function (Cr>2mg/dl or current renal dialysis)
Acute or chronic metabolic acidosis
Active liver disease or serum ALT or AST >2,5 than normal
History of hypoglycemia unawareness
Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
Pregnancy, 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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zeynep Cetin	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided