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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00280046
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : January 6, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Biphasic Insulin Aspart 30 on Glycaemic Control in Subjects With Type 2 Diabetes
Study Start Date : November 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00280046

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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
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00280046    
Other Study ID Numbers: BIASP-1554
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Hypoglycemic Agents
Physiological Effects of Drugs