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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

January 19, 2006
January 5, 2017
November 2003
July 2004   (Final data collection date for primary outcome measure)
HbA1c [ Time Frame: after 16 weeks of treatment ]
- HbA1c, measured after 16 weeks of treatment
Complete list of historical versions of study NCT00280046 on ClinicalTrials.gov Archive Site
  • Self-measured 7-point capillary plasma glucose profile
  • Change in body weight
  • Incidence of hypoglycaemic episodes and adverse events
  • Quality of Life
  • - Self-measured 7-point capillary plasma glucose profile
  • - Change in body weight
  • - Incidence of hypoglycaemic episodes and adverse events
  • - Quality of Life
Not Provided
Not Provided
 
Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 Diabetes
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Not Provided
Ushakova O, Sokolovskaya V, Morozova A, Valeeva F, Zanozina O, Sazonova O, Zhadanova E, Starceva M, Kazakova E, Saifullina M, Shapiro I, Tarasov A, Al-Tayar B, Starkova N. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia. Clin Ther. 2007 Nov;29(11):2374-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
307
July 2004
July 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
 
NCT00280046
BIASP-1554
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP