Glulisine + Lantus in Type I Patients

Diabetes Mellitus, Type 1 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545337
• Other study ID #: HMR1964A_3505UA
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2007
• Last updated: October 15, 2009
• Start date: September 2004
• Est. completion date: June 2005

Study information

• Verified date: October 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insuline glulisine

Locations

Country	Name	City	State
Ukraine	Sanofi-Aventis	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of HbA1c		from baseline to endpoint	No
Secondary	Change of HbA1c		from baseline to week 26	No
Secondary	Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins		from baseline to endpoint	No