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The determination of the exact time of administration of Lantus basal insulin for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs

The determination of the exact time of administration of Lantus basal insulin for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002958-21-HU
Enrollment
Unknown
Registered
2005-07-07
Start date
2005-09-21
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Type 2 diabetes mellitus

Interventions

Trade Name: Lantus Product Name: Lantus Product Code: HOE901 Pharmaceutical Form: Solution for injection INN or Proposed INN: insulin glargine Current Sponsor code: HOE901 Concentration unit: IU/ml in

Sponsors

Sanofi-Synthelabo Rt.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age between 40 and 65 years Both gender Type 2 diabetes mellitus Combined oral antidiabetic treatment (biguanid + sulfanylurea) BMI>25 kg/m2, 7.0% - =65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Type 1 diabetes mellitus known malignancy drug or alcohol abuse severe liver disease renal faliure (se kreatinin> 150 micromol/l) pregnancy, planned pregnancy, brest feeding

Design outcomes

Primary

MeasureTime frame
Main Objective: The determination of the exact time of administration of Lantus basal insulin.;Secondary Objective: ;Primary end point(s): The primary endpoints are the level of HbA1c by the end of both period—

Countries

Hungary

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026