Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes Mellitus

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):
Plamen Kozlovski, Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.

Official title: Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 Plus Metformin With Insulin Glargine Plus Glimepiride in Type 2 Diabetes

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

Primary outcome: HbA1c

Secondary outcome:

HbA1c

Plasma glucose profiles

Change in body mass index

Incidence of hypoglycaemic episodes

Safety profile

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

Criteria:

Inclusion Criteria:

- Type 2 diabetes for at least 6 months

- Insulin naive. Short term insulin treatment (7 days or less within the last 6 months)

is allowed

- Previous treatment with oral antidiabetic drugs for at least 4 months

- Judged by the investigator to be eligible for an insulin analogue plus oral

antidiabetic drug treatment regimen

- BMI below 40 kg/m2

- HbA1c between 7-12%

- Able and willing to perform self-plasma glucose monitoring

Exclusion Criteria:

- The receipt of any other investigational drug within 4 weeks before screening

- A history of drug or alcohol abuse within the last 12 months

- Severe, uncontrolled hypertension

- Known or suspected allergy to trial products or related products

Graz, Austria

Brno, Czech Republic

Marburg, Germany

Budapest, Hungary

Otwock, Poland

Martin, Slovakia

Ljubljana, Slovenia

Clinical Trials at Novo Nordisk

Starting date: December 2003
Last updated: February 11, 2008