Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807092

BIASP-3681

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insulin 30, both in combination with metformin in Chinese insulin-naive subjects with type 2 diabetes when failing on oral antidiabetic drug (OAD) therapy.

Enrollment: 145 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes diagnosed for at least 6 months
• Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
• Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial
• Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
• Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
• Glycosylated haemoglobin (HbA1c) between 7.5-11.0%
• Body Mass Index (BMI) between 18.5 - 35.0 kg/m^2
• Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)

Exclusion criteria

• Known or suspected allergy to trial product(s) or related products
• Any contraindication of metformin
• Receipt of investigational drug within the last 3 months prior to this trial
• Any history of chronic insulin therapy (more than 1 week of daily use)
• Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial
• Pregnancy, nursing mother, or unwillingness to use adequate contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

BIAsp 30

Experimental group

Description:

BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.

Treatment:

Drug: biphasic insulin aspart 30

Drug: metformin

BHI 30

Experimental group

Description:

BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.

Treatment:

Drug: metformin

Drug: biphasic human insulin 30