Insulin Analogues and Severe Hypoglycaemia

August 31, 2012 updated by: Lise Tarnow

The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients

Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.Secondary endpoints are effect on incidence of symptomatic and asymptomatic documented hypoglycaemia.

Study Design: An open, randomised, controlled, cross-over multi-centre study. Each treatment period lasts for one year. Patients will be randomised to treatment with basal bolus therapy with insulin detemir / aspart and insulatard / actrapid in random order. Endpoints will be assessed during the last 9 months of each treatment arm.

Patient population: 250 type 1 diabetic patients with a history of two or more episodes of severe hypoglycaemia during the preceding year.

Interventions: Basal bolus therapy with insulin detemir / aspart and insulatard / human actrapid in random order. Each treatment period lasts 12 months.

Methods: Patients will record all events of severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia in a diary and report all events of severe hypoglycaemia by telephone within 24 hours. All patients will be instructed to do and record home blood glucose monitoring (SMBG) i.e. 7 point profiles twice per week and nocturnal measurements once every month.

Outcomes: Severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia Efficacy: Number of reported episodes of severe, documented symptomatic and asymptomatic hypoglycaemia during the last 9 months of treatment - during daytime and night time.

Safety: Adverse reactions

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, DK-2820
        • Steno Diabetes center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes for 5 years.
  • Age>18 years.
  • Two or more episodes of hypoglycaemia during the last year,

Exclusion Criteria:

  • History of Addisons disease
  • Growth hormone deficiency or untreated myxoedema
  • CVD within 6 months
  • Cancer within 5 years
  • Alcohol or drug abuse
  • Pregnant or lactating women
  • Fertile women without effective contraception
  • Participation in another trial within 30 days
  • Inability to understand the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
HUman Insulin
Drug: human insulin /insulin isophane
for subcutaneous injection
Experimental: 2
Analogue insulin
Drug: insulin levemir / aspart
for subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severe hypoglycaemia
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
asymptomatic hypoglycaemia
Time Frame: 9 months
9 months
hypoglycaemia during nighttime
Time Frame: 9 months
9 months
hypoglycaemia during daytime
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lise Tarnow

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: LIse Tarnow, md, Steno Diabetes Center Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HypoAna

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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