NCT00469092
Completed
Phase 4
A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes
Overview
- Phase
- Phase 4
- Intervention
- biphasic insulin aspart
- Conditions
- Diabetes
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Glycosylated Haemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial is conducted in Africa, Asia, Europe, Oceania and South America.
This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
- •Ongoing stable treatment with metformin for at least 2 months
- •Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
- •Insulin naive
- •HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)
Exclusion Criteria
- •Metformin contraindication according to local practice
- •TZD (thiazolidinedione) treatment for the last 5 months before trial start
- •Systemic treatment with any corticosteroid 3 months before trial start
- •Any disease or condition which according to the Investigator would interfere with the trial
Arms & Interventions
BIAsp 30
Intervention: biphasic insulin aspart
BIAsp 30
Intervention: metformin
BIAsp 30
Intervention: glimepiride
Glargine
Intervention: insulin glargine
Glargine
Intervention: metformin
Glargine
Intervention: glimepiride
Outcomes
Primary Outcomes
Glycosylated Haemoglobin A1c (HbA1c)
Time Frame: After 26 weeks of treatment
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
Secondary Outcomes
- 9-point Self-measured Plasma Glucose Profiles(After 26 weeks of treatment)
- Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)(After 26 weeks of treatment)
- Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)(After 26 weeks of treatment)
- Number of Hypoglycaemic Episodes(Weeks 0-26)
- Number of Subjects Reporting Treatment Emergent Adverse Events(Weeks 0-26)
Study Sites (1)
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