Insulin Analogues and Severe Hypoglycaemia

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00346996
First received: June 30, 2006
Last updated: August 31, 2012
Last verified: August 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 179
Study Start Date: May 2007
Study Completion Date: August 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
HUman Insulin
Drug: human insulin /insulin isophane
for subcutaneous injection
Experimental: 2
Analogue insulin
Drug: insulin levemir / aspart
for subcutaneous injection
Other Name: n / A

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Steno Diabetes Center

Additional 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
Study First Received: June 30, 2006
Last Updated: August 31, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Steno Diabetes Center:
diabetes
insulin
insulin analogues
hypoglycaemia
severe hypoglycaemia

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

ClinicalTrials.gov processed this record on October 21, 2014