CClinicalTrials.gg
Sign In
CompletedNCT00701831LANTITUpdated Nov 4, 2010

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

A Phase 4 interventional study of Insulin glargine in Diabetes Mellitus, Type 2, sponsored by Sanofi. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-04.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
241
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 241 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
241 participants (actual)

Study arms

  • Experimental
    1

    Insulin glargine

    Drug: Insulin glargine

Interventions

  • DrugInsulin glargine

    The dose is titrated according to patient needs

06

What researchers measure

Primary outcomes

  1. HbA1c, FBG

    Time frame: after treatment end (6 months)

  2. Final dose

    Time frame: after treatment end (6 months)

  3. Number of dose adjustment

    Time frame: after treatment end (6 months)

  4. Time to dose titration

    Time frame: after treatment end (6 months)

Secondary outcomes

  1. Hypoglycemia

    Time frame: after treatment end (6 months)

  2. Noctural hypoglycemia

    Time frame: after treatment end (6 months)

  3. DTSQ

    Time frame: after treatment end (6 months)

  4. Physician Satisfaction Questionnaire

    Time frame: after treatment end (6 months)

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00701831
Lead sponsor
Sanofi
First posted
Jun 19, 2008
Start date
May 2008
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Nov 4, 2010

Study contacts

Zeynep Cetin
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

Sanofi

Start the discussion