Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes - Full Text View

Purpose

This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Insulin aspart

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: After 20 weeks of treatment ] [ Designated as safety issue: No ]
Percentage of subjects achieving HbA1c below or equal to 6.5% [ Time Frame: After 20 weeks of treatment ] [ Designated as safety issue: No ]
Change from baseline in FPG (Fasting Blood Glucose) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) [ Time Frame: Week 0 to week 20 (inclusive). ] [ Designated as safety issue: No ]

Enrollment:	343
Study Start Date:	June 2012
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Subject-driven titration	Drug: biphasic insulin aspart 30 Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily. Subjects continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor
Active Comparator: Investigator-driven titration	Drug: biphasic insulin aspart 30 Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily. Subjects continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alfa-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alfa-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
Total daily insulin dose below 1.4 IU/Kg
HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
BMI below or equal to 35.0 kg/m^2

Exclusion Criteria:

Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Known proliferative retinopathy or maculopathy requiring treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618214

Locations

China, Beijing

Beijing, Beijing, China, 100730

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Lili Pan	Novo Nordisk (China) Pharmaceuticals Co., Ltd
Study Director:	Bin Luo	Novo Nordisk (China) Pharmaceuticals Co., Ltd

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01618214 History of Changes
Other Study ID Numbers:	BIASP-3984, U1111-1126-7610
Study First Received:	June 11, 2012
Last Updated:	February 20, 2013
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart

Insulin
Hypoglycemic Agents
Insulin, NPH
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013