Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control (LANTIT)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701831

LANTU_L_03502

Details and patient eligibility

About

Primary objective:

• To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients

Secondary objectives:

• To assess the forced titration on physician and patient satisfaction
• To evaluate the impact of training tools by means of patient profile

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T2 insulin naïve patients
• Patients whom their physician is considering initiation of Lantus treatment
• Poor glycemic control 7,5 %10 %
• T2 treatment with OADs more than 3 months
• BMI<40 kg/m2

Exclusion criteria

• Impaired renal function (Cr>2mg/dl or current renal dialysis)
• Acute or chronic metabolic acidosis
• Active liver disease or serum ALT or AST >2,5 than normal
• History of hypoglycemia unawareness
• Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
• Pregnancy, breast feeding

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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241 participants in 1 patient group

1

Experimental group

Description:

Insulin glargine

Treatment:

Drug: Insulin glargine