NCT01487798|CompletedPhase 4

Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes

REACH

A Double-blind, Randomised, Crossover Study to Investigate the Difference in Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 Compared to Biphasic Human Insulin 30 in Patients With Well-controlled Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

BIASP-1466

Study Type

interventional

Target

170

Locations

1 country

Sites

Timeline

RegisteredDec 2011

StartedJun 2002

CompletionNov 2003

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the difference in frequency of episodes of hypoglycaemia during treatment with biphasic insulin aspart 30 compared to biphasic human insulin 30 in subjects with well controlled type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

170

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline

Completed

Started Jun 2002

Geographic Reach

1 country

17 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

1.4 years study duration

Study Start

First participant enrolled

June 1, 2002

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed

8.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed

Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

December 5, 2011

Last Update Submit

January 5, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Frequency of hypoglycaemic episodes

Secondary Outcomes (4)

Frequency of reported severe hypoglycaemic episodes
Overall frequency of nocturnal hypoglycaemia
HbA1c (glycosylated haemoglobin A1c)
Diabetes Treatment Satisfaction Questionaire

Study Arms (2)

Treatment period 1

EXPERIMENTAL

Drug: biphasic human insulin 30Drug: biphasic insulin aspart 30

Treatment period 2

ACTIVE COMPARATOR

Drug: biphasic human insulin 30Drug: biphasic insulin aspart 30

Interventions

biphasic human insulin 30DRUG

Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2

Treatment period 1Treatment period 2

biphasic insulin aspart 30DRUG

Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2

Treatment period 1Treatment period 2

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Treated with insulin 1-3 injections daily for at least 6 months
Body Mass Index (BMI) below 40 kg/m\^2
HbA1c (glycosylated haemoglobin A1c) below 9.5% at screening

You may not qualify if:

Total insulin dosage more than 1.8 IU/kg
Impaired hepatic or renal function or significant cardiac problems

Contact the study team to confirm eligibility.