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OpenTrials
Completed

NCT Number: NCT00397553

Insulin Glulisine, Diabetes Mellitus Type 1

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetes mellitus, Type 1
  • HbA1c 6.5-11.0%
  • BMI <35 kg/m²

Exclusion criteria

  • Diabetes mellitus, Type 2

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 glulisine

Drug

Primary outcomes

  1. HbA1c

    Time frame: 52 weeks

Secondary outcomes

  1. HbA1c

    Time frame: 26 weeks

  2. Fasting Blood Glucose

    Time frame: 26 weeks

  3. Fasting Blood Glucose

    Time frame: 52 weeks

  4. Post-prandial glycemia (2 hour after breakfast)

    Time frame: 26 weeks

  5. Post-prandial glycemia (2 hour after breakfast)

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Important dates

Study start
2005
Primary completion
2007
First posted
Nov 9, 2006
Registry last updated
Sep 18, 2009

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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