LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

This study has been terminated.

(prematurely terminated due to loss of interest)

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00349986

First received: July 7, 2006

Last updated: December 4, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2006

Last Updated Date

December 4, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HgbA1c measurement

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00349986 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

Official Title ^ICMJE

The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Insuline glargine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Hungary

Administrative Information

NCT Number ^ICMJE

NCT00349986

Other Study ID Numbers ^ICMJE

HOE901_4059

Has Data Monitoring Committee

Not Provided

Responsible Party

Medical Affairs Study Director, Sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

László Erős, MD

Sanofi

Information Provided By

Sanofi

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top