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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01278160
First received: January 14, 2011
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Trial of BIAsp-3756, Explorative Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens on the Effect of Glycaemic Control in Chinese Type 2 Diabetes Patients

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline [ Time Frame: Week 0, week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 9-point SMPG (Self Measured Plasma Glucose) Profile [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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

  • Percentage of Subjects Achieving HbA1c Below 7.0% [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment

  • Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c (HbA1c) after 16 weeks of treatment

  • Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Weeks 0-16 ] [ Designated as safety issue: No ]
    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).


Enrollment: 179
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 30 (2:1)
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
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.
Drug: metformin
Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged
Experimental: BIAsp 30 (1:1)
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
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.
Drug: metformin
Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278160

Locations
China, Beijing
Beijing, Beijing, China, 100029
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01278160     History of Changes
Other Study ID Numbers: BIASP-3883, U1111-1118-0330
Study First Received: January 14, 2011
Results First Received: September 14, 2012
Last Updated: October 16, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Globin Zinc
Insulin, Isophane
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014