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

NCT ID: NCT00807092

Last Updated: 2015-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-10-31

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIAsp 30

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.

Group Type: EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type: DRUG

The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner

metformin

Intervention Type: DRUG

Metformin dose must remain the same as that used prior to the trial.

BHI 30

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.

Group Type: EXPERIMENTAL

biphasic human insulin 30

Intervention Type: DRUG

The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner

metformin

Intervention Type: DRUG

Metformin dose must remain the same as that used prior to the trial.

Interventions

biphasic insulin aspart 30

The initial doses for BIAsp 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 U/kg body weight and to be equally divided (1/2:1/2) between pre-breakfast and pre-dinner

Intervention Type: DRUG

biphasic human insulin 30

The initial doses for BHI 30 twice-daily regimen will be recommended to start at a total daily dose of 0.3 IU/kg body weight and to be divided in the ratio of 2/3:1/3 between pre-breakfast and pre-dinner

Intervention Type: DRUG

metformin

Metformin dose must remain the same as that used prior to the trial.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Beijing, Beijing Municipality, China

Countries

China

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

BIASP-3681

Identifier Type: -

Identifier Source: org_study_id