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

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: insulin detemir (Drug); insulin aspart (Drug); biphasic insulin aspart (Device)

Phase: Phase 3

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Jens Larsen, Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

Official title: Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

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

Primary outcome: HbA1c

Secondary outcome:

Incidence of hypoglycaemic episodes

Adverse events

Difference of HbA1c change between the two groups

Fasting plasma glucose of treatment

Change in weight

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

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Duration of type 2 diabetes for at least 6 months since diagnosis

- Current treatment with one or two oral antidiabetic drugs for at least 3 months or

with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily

- BMI below 40 kg/m2

- HbA1c between 7-12%

- Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria:

- Current antidiabetic treatment with combination of three or more oral antidiabetic

drugs

- Previous treatment with short-acting human insulin, short-acting insulin analogue or

biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)

- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the

Investigator

- Known or suspected allergy to trial product or related products

- Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using

inadequate contraceptive measures

- Receipt of any investigational drug within 4 weeks prior to this trial

- Previous participation in this trial

Wien, Austria

Tübingen, Germany

Lugano, Switzerland

Clinical Trials at Novo Nordisk

Starting date: December 2003
Last updated: January 17, 2008