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OpenTrials
Completed

NCT Number: NCT00268645

Insulin Glargine in Type 2 Diabetes

The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine

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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

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 Diabetes Mellitus patients,
  • Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents,
  • Patients with HbA1C>8
  • Patients able to self-measure its blood glucose levels.

Exclusion criteria

  • According to package insert information (Summary of Product Characteristics)

Treatment and study plan

insulin glargine

Drug

Primary outcomes

  1. For efficacy: FBG (Fasting Blood Glucose), HbA1c

Secondary outcomes

  1. For safety: ICA (Insulin Cell Antibody)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Open Trial of the Safety and Efficacy of Lantus for Insulin Naive Type 2 Diabetes Mellitus Patients or Patients Who Use Insulin Combined With 1 or More Oral Antidiabetic Drugs and Don't Have Good Glycemic Control.

Important dates

Study start
2004
First posted
Dec 22, 2005
Registry last updated
Jan 11, 2011

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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