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

January 5, 2017 updated by: Novo Nordisk A/S

Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Benoni, South Africa, 1500
        • Novo Nordisk Investigational Site
      • Bloemfontein, South Africa, 27 51
        • Novo Nordisk Investigational Site
      • Kimberley, South Africa, 8301
        • Novo Nordisk Investigational Site
      • Richards Bay, South Africa, 3900
        • Novo Nordisk Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 2001
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0116
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
      • Pietermaritzburg, KwaZulu-Natal, South Africa, 3235
        • Novo Nordisk Investigational Site
    • North West
      • Brits, North West, South Africa, 0250
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7708
        • Novo Nordisk Investigational Site
      • Cape Town, Western Cape, South Africa, 7800
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes
  • Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
  • Body mass index (BMI) below 40.0 kg/m2
  • HbA1c between 7.5-13.0%

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Mental incapacity, unwillingness or language barriers precluding adequate
  • Subjects previously screened to participation or having already participated in this trial
  • Receipt of any investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: after 24 weeks of treatment
after 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Adverse events
Incidence of hypoglycaemic episodes
Plasma glucose profiles
Cardiovascular risk factors

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Naiker P, Makan HA, Kedijang T, Kong LLL, Omar MAK & the BIAsp-1579 Study Group. Effects of Once-Daily Biphasic Insulin Aspart 30 with Metformin versus Twice-Daily Biphasic Insulin Aspart 30 in South African Type 2 Diabetes Subjects. Society for Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA); Country: South Africa City: Bloemfontein
  • Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Effect of biphasic insulin aspart 30/70 (BIAsp30) in combination with metformin on glycaemic control in subjects with type 2 diabetes not optimally controlled on oral antidiabetic agents. EASD 2006 2006; 49(Suppl 1): 599
  • Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Efficacy of biphasic insulin aspart 30/70 with metformin on glycaemic control in poorly-controlled type 2 diabetes. IDF 2006 2006; 23(Suppl 4): 339 (P940)

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIASP-1579

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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