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NCT01487798 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— REACH  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01487798
Other study ID # BIASP-1466
Secondary ID
Status Completed
Phase Phase 4
First received December 5, 2011
Last updated January 5, 2017
Start date June 2002
Est. completion date November 2003

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date November 2003
Est. primary completion date November 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Total insulin dosage more than 1.8 IU/kg

- Impaired hepatic or renal function or significant cardiac problems

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic human insulin 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
• biphasic insulin aspart 30
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2

Locations
Country Name City State
United Kingdom Novo Nordisk Investigational Site Bolton
United Kingdom Novo Nordisk Investigational Site Cardiff
United Kingdom Novo Nordisk Investigational Site Derby
United Kingdom Novo Nordisk Investigational Site Dundee
United Kingdom Novo Nordisk Investigational Site Exeter
United Kingdom Novo Nordisk Investigational Site Galway
United Kingdom Novo Nordisk Investigational Site Glasgow
United Kingdom Novo Nordisk Investigational Site Leicester
United Kingdom Novo Nordisk Investigational Site Liverpool
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Newcastle
United Kingdom Novo Nordisk Investigational Site Nottingham
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Upton
United Kingdom Novo Nordisk Investigational Site Wirral, Merseyside
United Kingdom Novo Nordisk Investigational Site York

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

McNally PG, Dean JD, Morris AD, Wilkinson PD, Compion G, Heller SR. Using continuous glucose monitoring to measure the frequency of low glucose values when using biphasic insulin aspart 30 compared with biphasic human insulin 30: a double-blind crossover — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of hypoglycaemic episodes No
Secondary Frequency of reported severe hypoglycaemic episodes No
Secondary Overall frequency of nocturnal hypoglycaemia No
Secondary HbA1c (glycosylated haemoglobin A1c) No
Secondary Diabetes Treatment Satisfaction Questionaire No
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