Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 4

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: biphasic insulin aspart

Drug: insulin aspart

Study type

Interventional

Funder types

Industry

Identifiers

NCT00282451

BIASP-3024

Details and patient eligibility

About

This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.

Enrollment

79 patients

Sex

All

Ages

18 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetic subjects
Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
HbA1c at least 12%
Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion criteria

History of drug or alcohol dependence
Receipt of any investigational drug within the last month prior to this trial
Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
Severe uncontrolled hypertension
Recurrent severe hypoglycemia as judged by investigator
Any disease or condition, which the Investigator feels, would interfere with the trial