- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282451
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes
October 27, 2016 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aghakhan, Egypt
- Novo Nordisk Investigational Site
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Giza, Egypt
- Novo Nordisk Investigational Site
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Jeddah, Saudi Arabia, 80215
- Novo Nordisk Investigational Site
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Riyadh, Saudi Arabia, 245
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 18 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: At Visit 6 (14 weeks)
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At Visit 6 (14 weeks)
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Secondary Outcome Measures
Outcome Measure |
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Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
January 25, 2006
First Submitted That Met QC Criteria
January 25, 2006
First Posted (Estimate)
January 26, 2006
Study Record Updates
Last Update Posted (Estimate)
October 31, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
- Biphasic Insulins
Other Study ID Numbers
- BIASP-3024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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