Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

Novo Nordisk A/S394 enrolled

Overview

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

394

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

insulin NPHDRUG

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs * HbA1c between 8.0-10.5% * Body mass index (BMI) below 35.0 kg/m2 * Able and willing to perform self-monitoring of blood glucose Exclusion Criteria: * Total daily insulin dose of 1.80 IU/kg or more * Known or suspected allergy to trial product or related products * Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures

Locations (55)

Outcomes

Primary Outcomes

HbA1c

Time frame: after 4 months of treatment

Secondary Outcomes

8-point blood glucose profile

incidence of hypoglycaemic episodes

safety profiles

changes in body weight and vital signs

Data from ClinicalTrials.gov

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