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

• Status: Completed
• Trial end date: 2004-11-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting; Metformin

Criteria

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