Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus, Type 2

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

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novo Nordisk

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

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD treatment in type 2 diabetes and to verify the safety of use ( number and severity of episodes of hypoglycaemia, body weight and side effects).

Official title: 3 Year Efficacy and Safety Comparison of Adding Insulin Detemir, Biphasic Insulin Aspart 30 or Insulin Aspart to Oral Antidiabetic Drug Treatment in Type 2 Diabetes.

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

Primary outcome:

Proportion of subjects who achieve HbA1c = 6.5% without hypoglycaemia

Efficacy and durability of the insulin regimens

Secondary outcome:

Adverse events

body weight

Quality of Life

Blood glucose

Hypoglycaemia

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

Criteria:

Inclusion Criteria:

- Type 2 Diabetes

- Insulin naive

- On OAD treatment

- BMI = 40. 0 kg/m2

- HbA1c7. 0%-10% (both inclusive)

Exclusion Criteria:

- Proliferative retinopathy

- Recurrent major hypoglycaemia

- Cardial problems

- Uncontrolled hypertension

- Impaired hepatic or renal function

Dublin, Ireland

Oxford, United Kingdom

Clinical Trials at Novo Nordisk

Starting date: November 2004
Ending date: July 2009
Last updated: February 13, 2008