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OpenTrials
Completed

NCT Number: NCT00545337

Glulisine + Lantus in Type I Patients

To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus

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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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Kiev, Ukraine

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type I diabetes mellitus (onset of diabetes under the age of 40),
  • an HbA1c range of >6.5 - <11%,
  • and on multiple injection regimen (more than 1 year of continuous insulin treatment),
  • body mass index <35.

Exclusion criteria

  • Active proliferative diabetic retinopathy,
  • Diabetes other than type I diabetes mellitus,
  • Pancreatectomised subjects,
  • Subjects who have undergone pancreas and or islet cell transplants,
  • Requiring treatment with not permited drugs during the study,
  • Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine,
  • Hypersensitivity to insulin,
  • Major systemic diseases,
  • Impaired hepatic or renal function

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

Insuline glulisine

Drug

Primary outcomes

  1. Change of HbA1c

    Time frame: from baseline to endpoint

Secondary outcomes

  1. Change of HbA1c

    Time frame: from baseline to week 26

  2. Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins

    Time frame: from baseline to endpoint

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

26-week, International Multicenter, Open, Non-randomized Phase III Clinical Trial for Evaluation of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Subjects With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 17, 2007
Registry last updated
Oct 16, 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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