Insulin Analogues and Severe Hypoglycaemia - Full Text View

Sponsors and Collaborators:	Steno Diabetes Center Novo Nordisk
Information provided by:	Steno Diabetes Center
ClinicalTrials.gov Identifier:	NCT00346996

Purpose

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	Intervention	Phase
Type 1 Diabetes	Drug: insulin levemir / aspart Drug: human insulin /insulin isophane	Phase IV

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin Detemir Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	The Effect of Insulin Analogues and Human Insulin on the Incidence of Severe Hypoglycaemia in Hypoglycaemia Prone Type 1 Diabetic Patients

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:

Severe hypoglycaemia [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

asymptomatic hypoglycaemia [ Time Frame: 9 months ] [ Designated as safety issue: No ]
hypoglycaemia during nighttime [ Time Frame: 9 months ] [ Designated as safety issue: No ]
hypoglycaemia during daytime [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	370
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator HUman Insulin	Drug: human insulin /insulin isophane for subcutaneous injection
2: Experimental Analogue insulin	Drug: insulin levemir / aspart for subcutaneous injection

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346996

Contacts

Contact: Lise Tarnow, md	+45 44 43 99 52	ltar@steno.dk
Contact: Hans-Henrik Parving, MD	+45 22 17 81 60	hhparving@dadlnet.dk

Locations

Denmark
Steno Diabetes Center	Recruiting
Gentofte, Denmark, DK-2820
Contact: lise Tarnow, md
Principal Investigator: Lise Tarnow, MD

Sponsors and Collaborators

Steno Diabetes Center

Novo Nordisk

Investigators

Principal Investigator:

Lise Tarnow, MD

Steno Diabetes Center

More Information

Responsible Party:	Steno Diabetes Center ( Lise Tarnow )
Study ID Numbers:	HypoAna
Study First Received:	June 30, 2006
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00346996
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Steno Diabetes Center:

diabetes
insulin
insulin analogues
hypoglycaemia
severe hypoglycaemia

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009