Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278160

BIASP-3883

U1111-1118-0330 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).

Enrollment: 179 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in combination with metformin and glimepiride in trial BIAsp-3756
• HbA1c above or equal to 7.0%
• Body Mass Index (BMI) below or equal to 40.0 kg/m2

Exclusion criteria

• Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial BIAsp-3756
• Known proliferative retinopathy or maculopathy requiring acute treatment
• Any disease or condition which the Investigator (trial physician) feels would interfere with the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

BIAsp 30 (2:1)

Experimental group

Description:

After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: metformin

BIAsp 30 (1:1)

Experimental group

Description:

After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Drug: metformin