Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy (INITIATE)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin glargine; Drug: pioglitazone; Drug: biphasic insulin aspart; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00598793

BIASP-2163

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

Enrollment: 242 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Insulin naive Type 2 diabetes
• Currently treated with OADs alone or combined with other treatment for at least 3 months
• BMI below 40 kg/m2 and body weight below 125 kg
• HbA1c greater than or equal to 8%

Exclusion criteria

• Inability to tolerate metformin or contradictions to its use
• Pregnant, breastfeeding or intention of becoming pregnant
• Allergy to any of the trial products
• Inability or unwillingness to perform SMBG

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)