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Insulin Analogues and Severe Hypoglycaemia

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ClinicalTrials.gov Identifier: NCT00346996
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center Copenhagen

Tracking Information
First Submitted Date  ICMJE June 30, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date September 3, 2012
Study Start Date  ICMJE May 2007
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
Severe hypoglycaemia [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
Severe hypoglycaemia
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
  • asymptomatic hypoglycaemia [ Time Frame: 9 months ]
  • hypoglycaemia during nighttime [ Time Frame: 9 months ]
  • hypoglycaemia during daytime [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • symptomatic hypoglycaemia
  • asymptomatic hypoglycaemia
  • hypoglycaemia during nighttime
  • hypoglycaemia during daytime
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin Analogues and Severe Hypoglycaemia
Official Title  ICMJE The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients
Brief Summary 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Drug: insulin levemir / aspart
    for subcutaneous injection
  • Drug: human insulin /insulin isophane
    for subcutaneous injection
Study Arms  ICMJE
  • Active Comparator: 1
    HUman Insulin
    Intervention: Drug: human insulin /insulin isophane
  • Experimental: 2
    Analogue insulin
    Intervention: Drug: insulin levemir / aspart
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2012)
179
Original Enrollment  ICMJE
 (submitted: June 30, 2006)
250
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00346996
Other Study ID Numbers  ICMJE HypoAna
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lise Tarnow, Steno Diabetes Center Copenhagen
Study Sponsor  ICMJE Lise Tarnow
Collaborators  ICMJE Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Lise Tarnow, MD Steno Diabetes Center Copenhagen
PRS Account Steno Diabetes Center Copenhagen
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP