Glulisine + Lantus in Type I Patients

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546702
• Other study ID #: HMR1964A_3505
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: June 12, 2009
• Start date: September 2004
• Est. completion date: February 2005

Study information

• Verified date: June 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health and Social Development of the Russian Federation/Federal service of Russian Federation for Supervision in the sphere of Public Health and Social Development
• 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 To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult men and women (>18 years) with 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 transplantats, 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
Russian Federation	Sanofi-aventis	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of HbA1c.		from baseline to endpoint.	No
Secondary	Change in HbA1c.		from baseline (week 1) to weeks 12 and 26	No
Secondary	Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.		from baseline to endpoint.	No