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
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: insulin levemir / aspart Drug: human insulin /insulin isophane||Phase 4|
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|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||August 2012|
Active Comparator: 1
Drug: human insulin /insulin isophane
for subcutaneous injection
Drug: insulin levemir / aspart
for subcutaneous injection
- Severe hypoglycaemia [ Time Frame: 9 months ]
- asymptomatic hypoglycaemia [ Time Frame: 9 months ]
- hypoglycaemia during nighttime [ Time Frame: 9 months ]
- hypoglycaemia during daytime [ Time Frame: 9 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Type 1 diabetes for 5 years.
- Age>18 years.
- Two or more episodes of hypoglycaemia during the last year,
- 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
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|
|Principal Investigator:||Lise Tarnow, MD||Steno Diabetes Center Copenhagen|
|Responsible Party:||Lise Tarnow, professor, Steno Diabetes Center Copenhagen|
|Other Study ID Numbers:||
|First Posted:||July 4, 2006 Key Record Dates|
|Last Update Posted:||September 3, 2012|
|Last Verified:||August 2012|
Glucose Metabolism Disorders
Insulin, Globin Zinc
Isophane Insulin, Human
Isophane insulin, beef
Physiological Effects of Drugs