Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating Lantus(Insulin Glargine) Therapy to Determine Metabolic and Economic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00565162

Enrollment

124

Registered

2007-11-29

Start date

2003-11-30

Completion date

2005-06-30

Last updated

2008-08-25

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

Conditions

Diabetes Mellitus

Brief summary

To introduce initiation of glargine insulin treatment in primary care based on a patient education program. To show and compare feasibility of group education to individual education program.

Interventions

DRUGInsulin Glargine

Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Insulin-naive Type 2 Diabetes Mellitus subjects, aged ≥18 years and on stable oral anti-diabetic treatment for \>6 months requiring basal long-acting insulin (HbA1c \>7.5 % and \<12.0 %).

Exclusion criteria

* 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
Superiority is based on observing clinically significant difference in glycaemic control (> than or = to 0,5 % HbA1c). Programs are defined as equally successful if the HbA1c differs less than 0,5 %.	HbA1c values at visits 1, 2, 5 and 10

Countries

Finland, Netherlands, Sweden, United Kingdom

Outcome results

None listed

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