Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: biphasic insulin aspart (Drug); insulin glargine (Drug); metformin (Drug); glimepiride (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Pernille Gad, MSc, Study Director, Affiliation: Novo Nordisk A/S

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.

Official title: Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin Naive Subjects With Type 2 Diabetes.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c

Secondary outcome:

9-point plasma glucose profiles

Percentage of subjects reaching certain levels of HbA1c

Number of hypoglycaemic episodes

Treatment Satisfaction

Adverse events (AEs)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 between 7. 0% and 11. 0% (inclusive of both values)

Exclusion Criteria:

- Metformin contraindication according to local practice

- TZD 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

Buenos Aires C1405CWB, Argentina

Traisen 3160, Austria

Prague, Czech Republic

Paris, France

Karnal 132001, India

Kuala Lumpur, Malaysia

Mexico City 44340, Mexico

Rotterdam 3021 HC, Netherlands

Manila, Philippines

Zabrze, Poland

Bucharest, Romania

Brits 0205, South Africa

Madrid 28040, Spain

Stockholm, Sweden

Clinical Trials at Novo Nordisk

Starting date: May 2007
Ending date: April 2008
Last updated: April 14, 2008