LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

Sanofi

Status and phase: Terminated; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insuline glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349986

HOE901_4059

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)