Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

Novo Nordisk A/S26 enrolled

Overview

This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus for at least 12 months * HbA1c between 7.5-14.5% (inclusive) at screening * Insulin naïve * An antidiabetic regimen that has been stable for at least 3 months prior to screening * An antidiabetic regimen that includes a minimum of 2 OADs Exclusion Criteria: * Use of any insulin preparations within the past 6 months * Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to screening

Locations (1)

Unnamed facility

Pachuca, Mexico

Outcomes

Primary Outcomes

Percentage of subjects achieving HbA1c (glycosylated haemoglobin A1c) below 7.0%

Secondary Outcomes

Change in HbA1c

Total number of hypoglycemic events

Adverse events

Data from ClinicalTrials.gov

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