Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

Novo Nordisk A/S242 enrolled

Overview

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

242

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

insulin glargineDRUG

metforminDRUG

pioglitazoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Insulin naive Type 2 diabetes * Currently treated with OADs alone or combined with other treatment for at least 3 months * BMI below 40 kg/m2 and body weight below 125 kg * HbA1c greater than or equal to 8% Exclusion Criteria: * Inability to tolerate metformin or contradictions to its use * Pregnant, breastfeeding or intention of becoming pregnant * Allergy to any of the trial products * Inability or unwillingness to perform SMBG

Locations (27)

Outcomes

Primary Outcomes

HbA1c

Time frame: after 28 weeks of treatment

Secondary Outcomes

Postprandial glucose by 8-point SMBG

Number of subjects achieving HbA1c below 7%

Number of hypoglycemic episodes and adverse events

Weight change

Insulin dose

Data from ClinicalTrials.gov

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