Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes

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

Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes

This trial was conducted in Russian Federation. This trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 3

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

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Novo Nordisk Investigational Site
      • Belgorod, Russian Federation, 308007
        • Novo Nordisk Investigational Site
      • Ekaterinburg, Russian Federation, 620102
        • Novo Nordisk Investigational Site
      • Kazan, Russian Federation, 420064
        • Novo Nordisk Investigational Site
      • Khabarovsk, Russian Federation, 680067
        • Novo Nordisk Investigational Site
      • Nizhniy Novgorod, Russian Federation, 603126
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630090
        • Novo Nordisk Investigational Site
      • Omsk, Russian Federation, 644070
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194291
        • Novo Nordisk Investigational Site
      • Vladivostok, Russian Federation, 690105
        • Novo Nordisk Investigational Site
      • Voronezh, Russian Federation, 394053
        • 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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes, currently treated with one or more oral hypoglycemic agent
  • HbA1c: At least 8.0%

Exclusion Criteria:

  • Impaired hepatic, renal or cardiac function

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 16 weeks of treatment
after 16 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Quality of Life
Change in body weight
Self-measured 7-point capillary plasma glucose profile
Incidence of hypoglycaemic episodes and adverse events

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

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

November 1, 2003

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 20, 2006

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-1554

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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