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

NCT ID: NCT00592969

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-03

Study Completion Date

2004-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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metformin

Intervention Type DRUG

biphasic insulin aspart

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Mariano Acosta S/n, , Argentina

Site Status

Novo Nordisk Investigational Site

Santa Efigênia, , Brazil

Site Status

Countries

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Argentina Brazil

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-1570

Identifier Type: -

Identifier Source: org_study_id

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