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Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control (LANTIT)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Insulin glargine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Insulin glargine

Outcomes

Primary Outcome Measures

HbA1c, FBG

Final dose

Number of dose adjustment

Time to dose titration

Secondary Outcome Measures

Hypoglycemia

Noctural hypoglycemia

DTSQ

Physician Satisfaction Questionnaire

Full Information

NCT ID

NCT00701831

First Posted

June 18, 2008

Last Updated

November 3, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00701831

Brief Title

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

Acronym

LANTIT

Official Title

Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Insulin glargine

Intervention Type

Drug

Intervention Name(s)

Insulin glargine

Intervention Description

The dose is titrated according to patient needs

Primary Outcome Measure Information:

Title

HbA1c, FBG

Time Frame