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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01487798
First received: December 5, 2011
Last updated: December 7, 2011
Last verified: December 2011
  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
Endpoint Classification: Safety/Efficacy Study
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of reported severe hypoglycaemic episodes [ Designated as safety issue: No ]
  • Overall frequency of nocturnal hypoglycaemia [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]
  • Diabetes Treatment Satisfaction Questionaire [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487798

Locations
United Kingdom
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Stephen McDonough Novo Nordisk Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: December 7, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014