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Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)

NCT00627471 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2010-06-02

No results posted yet for this study

Summary

To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice.

To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice.

To compare the percentage of patients achieving HbA1c\< 7% in each treatment group.

To compare hypoglycaemic events (minor, severe and nocturnal) between groups.

To compare average insulin dose between groups.

To compare PRO (patients' reported outcomes) between groups.

To compare mean changes in body weight between treatment groups.

Conditions

Interventions

DRUG

Insulin Glargine

For the control group (following the physician's standard practice) a minimum of 4 visits to the clinic is required. Insulin titration and concomitant medications will be done at the discretion of the physician. Strips will be distributed among patients in this group, but there will not be a requirement in frequency or type of SMBG.

DRUG

Insulin Glargine

In the group following the algorithm, fasting SMBG will be asked 3 times a week until FBG\<100 mg/dl is achieved. Afterwards, 1 fasting SMBG will be asked weekly. Pre-prandial SMBG will be performed at the discretion of the physician. For the group following the algorithm, during the titration period, weekly telephone contacts will be required and a minimum of 4 visits to the clinic.

Sponsors & Collaborators

Principal Investigators

  • Cristian von Schulz-Hausmann · Sanofi-aventis administrative office Argentina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-03-31

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627471 on ClinicalTrials.gov