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OpenTrials
Completed

NCT Number: NCT00701831

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

The dose is titrated according to patient needs

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)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: LANTIT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 19, 2008
Registry last updated
Nov 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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