Insulin Analogues and Severe Hypoglycaemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346996
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : September 3, 2012
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center

June 30, 2006
July 4, 2006
September 3, 2012
May 2007
November 2011   (Final data collection date for primary outcome measure)
Severe hypoglycaemia [ Time Frame: 9 months ]
Severe hypoglycaemia
Complete list of historical versions of study NCT00346996 on Archive Site
  • asymptomatic hypoglycaemia [ Time Frame: 9 months ]
  • hypoglycaemia during nighttime [ Time Frame: 9 months ]
  • hypoglycaemia during daytime [ Time Frame: 9 months ]
  • symptomatic hypoglycaemia
  • asymptomatic hypoglycaemia
  • hypoglycaemia during nighttime
  • hypoglycaemia during daytime
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Insulin Analogues and Severe Hypoglycaemia
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

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

Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: insulin levemir / aspart
    for subcutaneous injection
  • Drug: human insulin /insulin isophane
    for subcutaneous injection
  • Active Comparator: 1
    HUman Insulin
    Intervention: Drug: human insulin /insulin isophane
  • Experimental: 2
    Analogue insulin
    Intervention: Drug: insulin levemir / aspart

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2012
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Lise Tarnow, Steno Diabetes Center
Lise Tarnow
Novo Nordisk A/S
Principal Investigator: Lise Tarnow, MD Steno Diabetes Center
Steno Diabetes Center
August 2012

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