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

NCT01278160 | Completed Phase 4 Results

• 2 other identifiers: BIASP-3883U1111-1118-0330
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline

  Week 0, week 16

Secondary Outcomes (4)

• 9-point SMPG (Self Measured Plasma Glucose) Profile

  Week 16

• Percentage of Subjects Achieving HbA1c Below 7.0%

  Week 16

• Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

  Week 16

• Number of Treatment Emergent Hypoglycaemic Episodes

  Weeks 0-16

Study Arms (2)

BIAsp 30 (2:1)

EXPERIMENTAL

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

Drug: biphasic insulin aspart 30; Drug: metformin

BIAsp 30 (1:1)

EXPERIMENTAL

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

Drug: biphasic insulin aspart 30; Drug: metformin

Interventions

biphasic insulin aspart 30 DRUG

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.

BIAsp 30 (2:1)

metformin DRUG

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

BIAsp 30 (1:1); BIAsp 30 (2:1)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Beijing, Beijing Municipality, 100029, 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; 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: January 14, 2011
• First Posted: January 17, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 27, 2014
• Results First Posted: October 18, 2012

Record last verified: 2014-10

Locations

CN (1)