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 A/S179 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

179

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.

biphasic insulin aspart 30DRUG

Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.

metforminDRUG

Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline

Time frame: Week 0, week 16

Secondary Outcomes

9-point SMPG (Self Measured Plasma Glucose) Profile

A 9-point SMPG profile included measurements before and 120 minutes after start of breakfast, lunch and main evening meal, measurements prior to bedtime and at 2:00 -4:00 a.m., and one before breakfast the following day

Time frame: Week 16

Percentage of Subjects Achieving HbA1c Below 7.0%

The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment

Time frame: Week 16

Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment

Time frame: Week 16

Number of Treatment Emergent Hypoglycaemic Episodes

Treatment emergent hypoglycaemic episodes (hypos): those that happened between treatment and one day after last drug day. Hypos summarised based on American Diabetes Association classification. Severe hypos: episodes requiring another person to actively administer resuscitative actions. Minor hypos: episodes with symptoms with plasma glucose below 3.1 mmol/L (56 mg/dL) handled by the subject, or any asymptomatic plasma glucose below 3.1 mmol/L (56 mg/dL). Diurnal period: between 06:00 and 23:59 (both included). Nocturnal period: between 00:00 and 05:59 a.m. (both included).

Time frame: Weeks 0-16

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.