NCT01618214|CompletedPhase 4Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

BIASP-3984U1111-1126-7610

Study Type

interventional

Target

344

Locations

1 country

Sites

Timeline

RegisteredJun 2012

StartedJun 2012

CompletionJan 2013

Brief Summary

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. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

344

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Jun 2012

Shorter than P25 for phase_4 diabetes

Geographic Reach

1 country

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

June 1, 2012

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed

Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

June 11, 2012

Results QC Date

January 30, 2014

Last Update Submit

January 10, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Week 0, week 20

Secondary Outcomes (4)

Percentage of Subjects Achieving HbA1c Below 7.0%
After 20 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
After 20 weeks of treatment
Change From Baseline in FPG (Fasting Plasma Glucose)
Week 0, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Week 0 to week 20 (inclusive).

Study Arms (2)

Subject-driven titration

EXPERIMENTAL

Drug: biphasic insulin aspart 30

Investigator-driven titration

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.

Investigator-driven titrationSubject-driven titration

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 alpha-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 alpha-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)
Body Mass Index (BMI) below or equal to 35.0 kg/m\^2

You may not qualify if:

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

Contact the study team to confirm eligibility.