Insulin Glargine "All to Target" Trial

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Premixed Insulin; Drug: Insulin Glargine; Drug: Insulin Glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384085

HMR1964A_3515

Details and patient eligibility

About

The primary objectives were:

• To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%) at Week 60
• To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Enrollment: 588 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Male or female patients
• 30 to 80 years of age
• Body Mass Index <45 kg/m2
• With Type 2 diabetes mellitus for at least 2 years
• With an HbA1c level at screening of >7.5% and >7.0% at randomization
• On stable dual or triple oral therapy for at least 3 months
• Oral agents in 2 or 3 of the following classes: SU or repaglinide, biguanide, or TZD, willing and able to perform self-monitoring of BG
• Females of child-bearing potentially were required to be willing and able to use adequate contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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588 participants in 3 patient groups

Lantus/Apidra-3

Experimental group

Description:

Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.

Treatment:

Drug: Insulin Glulisine

Drug: Insulin Glulisine

Drug: Insulin Glargine

Lantus/Apidra-1

Experimental group

Description:

Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.

Treatment:

Drug: Insulin Glulisine

Drug: Insulin Glulisine

Drug: Insulin Glargine

Novolog Mix 70/30

Experimental group

Description:

Premixed insulin (Novolog® Mix 70/30) added to oral agents.

Treatment:

Drug: Premixed Insulin