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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01697657
First received: September 28, 2012
Last updated: January 26, 2017
Last verified: January 2017
  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
Intervention Model: Crossover Assignment
Masking: No masking
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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of total self-recorded hypoglycaemic episodes

Secondary Outcome Measures:
  • Incidence of total major hypoglycaemic episodes
  • HbA1c (glycosylated haemoglobin)
  • 8-point plasma glucose profiles
  • Serum glucose profiles
  • 72-hours glucose profile
  • Within-subject variation in home-measured fasting plasma glucose
  • Incidence of adverse events

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 to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01697657

Locations
Australia, New South Wales
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia
Novo Nordisk Investigational Site
Ashford, Australia, 5035
Novo Nordisk Investigational Site
Box Hill, Australia, 3128
Croatia
Novo Nordisk Investigational Site
Zagreb, Croatia, 10 000
Denmark
Novo Nordisk Investigational Site
Køge, Denmark, 4600
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Italy
Novo Nordisk Investigational Site
Citta' Di Castello, Italy, 06012
Novo Nordisk Investigational Site
Perugia, Italy, 06126
South Africa
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7925
Sweden
Novo Nordisk Investigational Site
Linköping, Sweden, 581 85
Novo Nordisk Investigational Site
Trelleborg, Sweden, 231 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: 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: January 26, 2017

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

ClinicalTrials.gov processed this record on March 28, 2017