Insulin Glargine in Type 2 Diabetes

Open Trial of the Safety and Efficacy of Lantus for Insulin Naive Type 2 Diabetes Mellitus Patients or Patients Who Use Insulin Combined With 1 or More Oral Antidiabetic Drugs and Don't Have Good Glycemic Control.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00268645

Enrollment

534

Registered

2005-12-22

Start date

2004-09-30

Completion date

Unknown

Last updated

2011-01-11

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

Conditions

Diabetes Mellitus, Type 2

Brief summary

The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine

Interventions

DRUGInsulin Glargine

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

* Type 2 Diabetes Mellitus patients, * Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents, * Patients with HbA1C\>8 * Patients able to self-measure its blood glucose levels.

Exclusion criteria

* According to package insert information (Summary of Product Characteristics)

Design outcomes

Primary

Measure	Time frame
For efficacy: FBG (Fasting Blood Glucose), HbA1c	—

Secondary

Measure	Time frame
For safety: ICA (Insulin Cell Antibody)	—

Countries

Turkey (Türkiye)

Outcome results

None listed

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