Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes (REACH)

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 30; Drug: biphasic human insulin 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01487798

BIASP-1466

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Treated with insulin 1-3 injections daily for at least 6 months
• Body Mass Index (BMI) below 40 kg/m^2
• HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening

Exclusion criteria

• Total insulin dosage more than 1.8 IU/kg
• Impaired hepatic or renal function or significant cardiac problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic human insulin 30

Treatment period 2

Active Comparator group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic human insulin 30