Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: metformin; Drug: biphasic insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00592969

BIASP-1570

Details and patient eligibility

About

This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Currently treated with insulin NPH or are insulin-naive
• Body mass index (BMI) below 35.0 kg/m2
• HbA1c between 7.5-11.0%

Exclusion criteria

• Participation in any other clinical trial involving investigational products within the last 3 months
• History of drug or alcohol dependence
• Known impaired hepatic function
• Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)