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CompletedNCT00545337Updated Oct 16, 2009

Glulisine + Lantus in Type I Patients

A Phase 3 interventional study of Insuline glulisine in Diabetes Mellitus, Type 1, sponsored by Sanofi. Completed at 1 site in Ukraine. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2009-10-16.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Interventions

  • DrugInsuline glulisine
06

What researchers measure

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

07

Study locations

1 site
  • Sanofi-Aventis
    Kiev, Ukraine
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00545337
Lead sponsor
Sanofi
First posted
Oct 17, 2007
Start date
Sep 2004
Primary completion
Jun 2005
Completion
Jun 2005
Last update
Oct 16, 2009

Study contacts

Volodymyr Moshchych
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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