Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00282451
First received: January 25, 2006
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: 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: Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-center, Randomized, Open-labeled, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: At Visit 6 (14 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles) [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: February 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic subjects
  • Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
  • HbA1c at least 12%
  • Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Receipt of any investigational drug within the last month prior to this trial
  • Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
  • Severe uncontrolled hypertension
  • Recurrent severe hypoglycemia as judged by investigator
  • Any disease or condition, which the Investigator feels, would interfere with the trial
  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: NCT00282451

Locations
Egypt
Giza, Egypt
Saudi Arabia
Riyadh, Saudi Arabia, 245
Riyadh, Saudi Arabia
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Rasha El Kassas Novo Nordisk Egypt
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00282451     History of Changes
Other Study ID Numbers: BIASP-3024
Study First Received: January 25, 2006
Last Updated: October 21, 2013
Health Authority: Saudi Arabia: Ministry of Health
Egypt: Ministry of Health and Population

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014