Insulin Glulisine, Diabetes Mellitus Type 1

Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00397553

Enrollment

104

Registered

2006-11-09

Start date

2005-01-31

Completion date

Unknown

Last updated

2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Brief summary

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Interventions

DRUGInsulin glulisine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diabetes mellitus, Type 1 * HbA1c 6.5-11.0% * BMI \<35 kg/m²

Exclusion criteria

* Diabetes mellitus, Type 2 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame
HbA1c	52 weeks

Secondary

Measure	Time frame
HbA1c	26 weeks
Fasting Blood Glucose	26 weeks
Post-prandial glycemia (2 hour after breakfast)	26 weeks

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026