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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
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: insulin levemir / aspart Drug: human insulin /insulin isophane Phase 4

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  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients
Study Start Date : May 2007
Primary Completion Date : November 2011
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Severe hypoglycaemia [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. asymptomatic hypoglycaemia [ Time Frame: 9 months ]
  2. hypoglycaemia during nighttime [ Time Frame: 9 months ]
  3. hypoglycaemia during daytime [ Time Frame: 9 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346996

Steno Diabetes Center
Gentofte, Denmark, DK-2820
Sponsors and Collaborators
Lise Tarnow
Novo Nordisk A/S
Principal Investigator: Lise Tarnow, MD Steno Diabetes Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lise Tarnow, professor, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT00346996     History of Changes
Other Study ID Numbers: HypoAna
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Lise Tarnow, Steno Diabetes Center:
insulin analogues
severe hypoglycaemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs