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Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01697657
First received: September 28, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: insulin detemir
Drug: insulin NPH
Drug: insulin aspart
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open Label, Cross-over, Multi-centre, Multinational Trial Comparing the Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir and NPH Insulin in Well Controlled Subjects With Type 1 Diabetes on a Basal-bolus Regimen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Incidence of total self-recorded hypoglycaemic episodes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of total major hypoglycaemic episodes [ Designated as safety issue: No ]
  • HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • 8-point plasma glucose profiles [ Designated as safety issue: No ]
  • Serum glucose profiles [ Designated as safety issue: No ]
  • 72-hours glucose profile [ Designated as safety issue: No ]
  • Within-subject variation in home-measured fasting plasma glucose [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: September 2001
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Detemir Drug: insulin detemir
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Drug: insulin aspart
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Active Comparator: NPH Drug: insulin NPH
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
Drug: insulin aspart
Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2

  Eligibility

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

Inclusion Criteria:

  • Type 1 diabetes
  • Fasting c-peptide below lower limit of normal fasting range
  • Duration of type 1 diabetes for at least 12 months
  • Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections
  • HbA1c maximum 9.0% (using Biorad Variant method)
  • Able and willing to perform self-monitoring of blood glucose
  • Basal insulin requirement at least 30% of the total daily insulin dose
  • BMI (body Mass Index) maximum 35 kg/m^2

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Total daily insulin dose above 1.4 IU/kg/day
  • Known unawareness of hypoglycaemia
  • Impaired hepatic function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled, treated/untreated hypertension
  • Known or suspected allergy to trial product or related products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697657

Locations
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Croatia
Zagreb, Croatia, 10 000
Denmark
Århus C, Denmark, 8000
Italy
Perugia, Italy, 06126
South Africa
Cape Town, Western Cape, South Africa, 7925
Sweden
Linköping, Sweden, 581 85
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Bente Tronier Novo Nordisk
Study Director: Malene Bording Krüger Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01697657     History of Changes
Other Study ID Numbers: NN304-1375
Study First Received: September 28, 2012
Last Updated: September 28, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
Italy: National Institute of Health
South Africa: Medicines Control Council
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Hypoglycemic Agents
Insulin, NPH
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013