NCT01697631|CompletedPhase 4

Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Comparison of Biphasic Insulin Aspart 30 Twice Daily and Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart Treatment Efficiency in Overall Glycemic Control and Postprandial Glycemic Excursions. A Multi-center, Randomized, Open-label, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

BIASP-1409

Study Type

interventional

Target

131

Locations

1 country

Sites

Timeline

RegisteredOct 2012

StartedJul 2002

CompletionApr 2003

Brief Summary

This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

Trial Health

On Track

Trial Health Score

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

Enrollment

131

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline

Completed

Started Jul 2002

Shorter than P25 for phase_4 diabetes

Geographic Reach

1 country

12 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

9 months study duration

Study Start

First participant enrolled

July 22, 2002

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2003

Completed

9.4 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed

Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

September 28, 2012

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c (glycosylated haemoglobin)

Secondary Outcomes (4)

7-point blood glucose profile
Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification
Incidence of adverse events
Hypoglycaemic episodes (minor, major or nocturnal)

Study Arms (2)

BIAsp

EXPERIMENTAL

Drug: biphasic insulin aspart 30

Insulin aspart

EXPERIMENTAL

Drug: biphasic insulin aspart 30Drug: insulin aspart

Interventions

biphasic insulin aspart 30DRUG

Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

BIAspInsulin aspart

insulin aspartDRUG

Administrated subcutaneously (s.c., under the skin) before lunch

Insulin aspart

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
HbA1c (glycosylated haemoglobin) equal to or below 12%
Willing and able to perform self blood glucose monitoring (SMBG)

You may not qualify if:

History of drug or alcohol dependence
Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
Previous participation in this trial
Receipt of any investigational drug within the last month prior to this trial
Known or suspected allergy to trial products or related products

Contact the study team to confirm eligibility.