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OpenTrials
Completed

NCT Number: NCT00322075

LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year

Exclusion criteria

  • Diabetic ketoacidosis
  • Any other severe disease
  • Pregnancy or fertile female without contraception
  • Alcohol/drug abuse, selected prohibited concomitant medication
  • Nightshift work

Treatment and study plan

insulin glargine

Drug

Primary outcomes

  1. 3 days continual glycaemic profile fluctuation

  2. occurrence of adverse events

  3. HbA1c

  4. FBG

  5. BMI

  6. total daily dose of insulin and ratio of doses of basal/prandial insulines

  7. patients´satisfaction

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine

Important dates

Study start
2006
Study completion
2006
First posted
May 4, 2006
Registry last updated
Sep 12, 2007

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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