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

Novo Nordisk A/S164 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

metforminDRUG

biphasic insulin aspartDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Novo Nordisk Investigational Site

Mariano Acosta S/n, Argentina

Novo Nordisk Investigational Site

Santa Efigênia, Brazil

Outcomes

Primary Outcomes

HbA1c

Time frame: after 12 weeks of treatment

Secondary Outcomes

PPBG values

Glucose profiles

Hypoglycemia

Adverse events

Data from ClinicalTrials.gov

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