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OpenTrials
Completed

NCT Number: NCT00467376

Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

Primary:

* To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus. * To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.

Secondary:

* To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Completed

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 or type 2 diabetic patients
  • Measure HbA1c 6.5% to 11.0% at visit 1
  • More than 3 months of continuous insulin treatment immediately prior to study entry

Exclusion criteria

  • Pregnant women

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

3 times a day before each meal

Lispro

Drug

3 times a day before each meal

insulin glargine

Drug

once daily

Primary outcomes

  1. Hypoglycemic episodes

    Time frame: From the beginning to end of the study

  2. Change in HbA1c

    Time frame: From baseline to endpoint

  3. Adverse events

    Time frame: From the beginning to the end of study

Secondary outcomes

  1. Change in HbA1c

    Time frame: From baseline to weeks 12

  2. blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.

    Time frame: from baseline to week 12

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)

Important dates

Study start
2007
Primary completion
2008
First posted
Apr 30, 2007
Registry last updated
Sep 15, 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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