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

NCT00807092 | Completed Phase 4 Results

• 1 other identifier: BIASP-3681
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in IAUC (Incremental Area Under the Curve) for Postprandial Glucose (0-4 Hours) Over 3 Main Meals

  The blood glucose profiles were monitored by CGMS (Continuous Glucose Monitoring System) for 72 hours at baseline (week 0) and end of treatment (week 6). IAUC was calculated using the trapezoidal method. The arithmetic mean of IAUC (3 meal-specific incremental areas) of day 1 and day 2 was used as the value of IAUC for each CGMS period

  Week 0, week 6

Secondary Outcomes (11)

• Change in Mean IAUC for Postprandial Glucose (0-4 Hours) After Each Meal (Breakfast, Lunch, Dinner) Assessed by CGMS

  Week 0, Week 6

• Mean FBG (Fasting Blood Glucose) Assessed by CGMS

  Week 6

• Change in Mean FBG Assessed by CGMS

  Week 0, week 6

• Change in FPG (Fasting Plasma Glucose)

  Week 0, Week 6

• Change in 8-point SMBG (Self-monitored Blood Glucose) Profiles

  Week 0, Week 6

Study Arms (2)

BIAsp 30

EXPERIMENTAL

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.

Drug: biphasic insulin aspart 30; Drug: metformin

BHI 30

EXPERIMENTAL

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.

Drug: biphasic human insulin 30; Drug: metformin

Interventions

biphasic insulin aspart 30 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

BIAsp 30

biphasic human insulin 30 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

BHI 30

metformin DRUG

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

BHI 30; BIAsp 30

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Beijing, Beijing Municipality, 100730, China

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70; biphasic human insulin 30; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 4, 2015
• Results First Posted: April 11, 2011

Record last verified: 2015-02

Locations

CN (1)