Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 293
- Primary Endpoint
- Change in HbA1c (Glycosylated Haemoglobin A1c)
Overview
Brief Summary
This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes
- •Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
- •HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
- •BMI (Body Mass Index) maximum 40 kg/m2
Exclusion Criteria
- •Metformin contraindications according to local practice
- •Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial
Arms & Interventions
BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Intervention: biphasic insulin aspart 30 (Drug)
BIAsp 30-30
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Intervention: metformin (Drug)
Outcomes
Primary Outcomes
Change in HbA1c (Glycosylated Haemoglobin A1c)
Time Frame: week 0, week 16
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)
Secondary Outcomes
- Change in 8-point Plasma Glucose Profile(week 0, week 16)
- Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%(week 16)
- Hypoglycaemic Episodes(weeks 0-16)
- Percentage of Subjects Achieving HbA1c Less Than 7.0%(week 16)
- Hypoglycaemic Episodes, Diurnal/Nocturnal(weeks 0-16)