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Completed

NCT Number: NCT01487798

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Bolton, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic human insulin 30

Drug

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

Drug

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

Primary outcomes

  1. Frequency of hypoglycaemic episodes

Secondary outcomes

  1. Frequency of reported severe hypoglycaemic episodes

  2. Overall frequency of nocturnal hypoglycaemia

  3. HbA1c (glycosylated haemoglobin A1c)

  4. Diabetes Treatment Satisfaction Questionaire

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: REACH

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Dec 7, 2011
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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