LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00349986

Enrollment

Registered

2006-07-10

Start date

2006-09-30

Completion date

Unknown

Last updated

2009-12-07

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 rationale of the study is to determine: * the first dose and the titration of basal insulin * the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

Interventions

DRUGInsuline glargine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Type 2 Diabetes Mellitus * Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea) * BMI \>25 kg/m2 , \<30 kg/m2 * HbA1c value \>7.0%, \<9.0% within one month

Exclusion criteria

* Type 1 Diabetes Mellitus * Known malignancy * Drug or alcohol abuse * Severe liver disease * Renal failure (se Creatinine \> 150 micro mol/l) 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
HgbA1c measurement	—

Countries

Hungary

Outcome results

None listed

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