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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01487798
First received: December 5, 2011
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic human insulin 30
Drug: biphasic insulin aspart 30
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Enrollment: 170
Study Start Date: June 2002
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment period 1 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
Drug: 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
Active Comparator: Treatment period 2 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
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487798

Locations
United Kingdom
Novo Nordisk Investigational Site
Bolton, United Kingdom, BL1 4QS
Novo Nordisk Investigational Site
Cardiff, United Kingdom, CF14 4XW
Novo Nordisk Investigational Site
Derby, United Kingdom, DE7 1DY
Novo Nordisk Investigational Site
Dundee, United Kingdom, DD1 9SY
Novo Nordisk Investigational Site
Exeter, United Kingdom, EX2 5AX
Novo Nordisk Investigational Site
Galway, United Kingdom, EIRE
Novo Nordisk Investigational Site
Glasgow, United Kingdom, G4 0SF
Novo Nordisk Investigational Site
Leicester, United Kingdom, LE1 5WW
Novo Nordisk Investigational Site
Liverpool, United Kingdom, L7 8XP
Novo Nordisk Investigational Site
London, United Kingdom, NW10 7NS
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Novo Nordisk Investigational Site
Newcastle, United Kingdom, NE7 7DN
Novo Nordisk Investigational Site
Nottingham, United Kingdom, NG7 2UH
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S5 7AU
Novo Nordisk Investigational Site
Upton, United Kingdom, L49 5PE
Novo Nordisk Investigational Site
Wirral, Merseyside, United Kingdom, CH63 4JY
Novo Nordisk Investigational Site
York, United Kingdom, YO3 7HE
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01487798     History of Changes
Other Study ID Numbers: BIASP-1466 
Study First Received: December 5, 2011
Last Updated: January 5, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Insulin
Insulin, Isophane
Biphasic Insulins
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 23, 2017