NCT00282451
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- HbA1c
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 18 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
HbA1c
Time Frame: At Visit 6 (14 weeks)
Secondary Outcomes
- Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)
Investigators
Study Sites (1)
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