NCT01467323|CompletedPhase 3

Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

ANA/DCD/038

Study Type

interventional

Target

303

Locations

5 countries

Sites

Timeline

RegisteredNov 2011

StartedApr 1998

CompletionSep 1998

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

303

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Apr 1998

Shorter than P25 for phase_3 diabetes

Geographic Reach

5 countries

37 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

5 months study duration

Study Start

First participant enrolled

April 1, 1998

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1998

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1998

Completed

13.2 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed

Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

November 4, 2011

Last Update Submit

January 3, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c (glycosylated haemoglobin A1c)

Secondary Outcomes (3)

8-point blood glucose profiles
Incidence of hypoglycaemic episodes
Occurrence of adverse events

Study Arms (2)

A

EXPERIMENTAL

Drug: biphasic insulin aspart

B

ACTIVE COMPARATOR

Drug: biphasic human insulin

Interventions

biphasic insulin aspartDRUG

Injected subcutaneously (under the skin) twice daily

biphasic human insulinDRUG

Injected subcutaneously (under the skin) twice daily

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months
Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months
Body mass index (BMI) below or equal to 35.0 kg/m\^2
HbA1c below or equal to 11.0%

You may not qualify if:

Total daily insulin dose at least 1.4 IU/kg
Recurrent severe hypoglycaemia (as judged by the investigator)
Active proliferative retinopathy
Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl)
History of pancreatitis

Contact the study team to confirm eligibility.