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Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01650129
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of biphasic insulin aspart (BIAsp) 50 (NN-X14Mix50) compared with biphasic human insulin (BHI) 50 in subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 50 Drug: biphasic human insulin 50 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-labelled, Randomised, Parallel Group, Multicentre, Safety and Efficacy Study of NN-X14Mix50 (BIAsp50) in a Twice Daily Regimen in Type 2 Diabetic Subjects
Actual Study Start Date : December 13, 2000
Primary Completion Date : October 18, 2001
Study Completion Date : October 18, 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BIAsp Drug: biphasic insulin aspart 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
Experimental: BHI Drug: biphasic human insulin 50
Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner


Outcome Measures

Primary Outcome Measures :
  1. Glycosylated haemoglobin A1c (HbA1c)

Secondary Outcome Measures :
  1. Occurrence of adverse event(s)
  2. Blood glucose
  3. Incidence of hypoglycaemic episodes
  4. Change from baseline in insulin antibodies
  5. Insulin doses

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with type 2 diabetes
  • Subjects with insulin treated for at least 24 weeks
  • HbA1c maximum 11.0%
  • Body mass index (BMI) below 30.0 kg/m^2
  • Patients who have the skill of self-injection of insulin, and are able and willing to perform self-monitoring blood glucose (SMBG) and are able to take measures against hypoglycaemic episodes

Exclusion Criteria:

  • Recurrent severe hypoglycaemia
  • Subjects with proliferative retinopathy or preproliferative retinopathy diagnosed within the last 12 weeks, or receiving photocoagulation therapy within the last one year
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac diseases
  • Uncontrolled hypertension
  • Subjects with history of severe allergic or severe hypersensitive reactions
  • Total daily insulin dose at least 100 IU
  • Treatment with oral hypoglycaemic agentsvwithin the last 4 weeks
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650129


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01650129     History of Changes
Other Study ID Numbers: BIASP-1352
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs