LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus | NCT00349986

Studies
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

NCT00349986

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Dec 7, 2009Estimated

Enrollment

4Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

Insuline glargine

Countries

Hungary

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

prematurely terminated due to loss of interest

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Not provided

First Submitted Date

Jul 7, 2006

First Submission Date that Met QC Criteria

Jul 7, 2006

First Posted Date

Jul 10, 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

Dec 4, 2009

Last Update Posted Date

Dec 7, 2009Estimated

Description Module

Brief Summary

The rationale of the study is to determine:

the first dose and the titration of basal insulin
the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

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

4Actual

Name	Type	Description	Arm Group Labels	Other Names
Insuline glargine	Drug

Measure	Description	Time Frame
HgbA1c measurement

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 Diabetes Mellitus
Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
BMI >25 kg/m2 , <30 kg/m2
HbA1c value >7.0%, <9.0% within one month

Exclusion Criteria:

Type 1 Diabetes Mellitus
Known malignancy
Drug or alcohol abuse
Severe liver disease
Renal failure (se Creatinine > 150 micro mol/l)

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

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
László Erős, MD	Sanofi	Study Director

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