Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00701831

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Insulin glargine	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

HbA1c, FBG [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
Final dose [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
Number of dose adjustment [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
Time to dose titration [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hypoglycemia [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: Yes ]
Noctural hypoglycemia [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: Yes ]
DTSQ [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]
Physician Satisfaction Questionnaire [ Time Frame: after treatment end (6 months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	May 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Insulin glargine	Drug: Insulin glargine The dose is titrated according to patient needs

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701831

Contacts

Contact: PUBLIC REGISTRY GMA

publicregistrygma@sanofi-aventis.com

Locations

Turkey
Sanofi aventis administrative office	Recruiting
İstanbul, Turkey

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Zeynep Cetin

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LANTU_L_03502
Study First Received:	June 18, 2008
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00701831 History of Changes
Health Authority:	Turkey: Ministry of Health

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009