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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
biphasic human insulin 30
biphasic insulin aspart 30
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment period 1

Treatment period 2

Arm Description

Outcomes

Primary Outcome Measures

Frequency of hypoglycaemic episodes

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2011
Last Updated
January 5, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01487798
Brief Title
Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment period 1
Arm Type
Experimental
Arm Title
Treatment period 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
biphasic human insulin 30
Intervention Description
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
Primary Outcome Measure Information:
Title
Frequency of hypoglycaemic episodes
Secondary Outcome Measure Information:
Title
Frequency of reported severe hypoglycaemic episodes
Title
Overall frequency of nocturnal hypoglycaemia
Title
HbA1c (glycosylated haemoglobin A1c)
Title
Diabetes Treatment Satisfaction Questionaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Bolton
ZIP/Postal Code
BL1 4QS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Derby
ZIP/Postal Code
DE7 1DY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Exeter
ZIP/Postal Code
EX2 5AX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Galway
ZIP/Postal Code
EIRE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
NW10 7NS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Upton
ZIP/Postal Code
L49 5PE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Wirral, Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
York
ZIP/Postal Code
YO3 7HE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17277042
Citation
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 study in individuals with type 2 diabetes. Diabetes Care. 2007 May;30(5):1044-8. doi: 10.2337/dc06-1328. Epub 2007 Feb 2.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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