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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00280046
First received: January 19, 2006
Last updated: June 15, 2012
Last verified: June 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-measured 7-point capillary plasma glucose profile [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes and adverse events [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Vladivostok, Russian Federation
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Ninella Starkova, MD, PhD Novo Nordisk Russia
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: June 15, 2012
Health Authority: Russia: Federal Service for control in Health and Social development

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
Biphasic Insulins
Insulin Aspart
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014