LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00349986
• Other study ID #: HOE901_4059
• Status: Terminated
• Phase: Phase 4
• First received: July 7, 2006
• Last updated: December 4, 2009
• Start date: September 2006

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insuline glargine

Locations

Country	Name	City	State
Hungary	Sanofi-Aventis	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HgbA1c measurement