Try our beta test site

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00280046
First received: January 19, 2006
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 16 weeks of treatment ]

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

Enrollment: 307
Study Start Date: November 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280046

Locations
Russian Federation
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00280046     History of Changes
Other Study ID Numbers: BIASP-1554 
Study First Received: January 19, 2006
Last Updated: January 5, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Insulin
Insulin, Isophane
Biphasic Insulins
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 17, 2017