- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01697657
Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes
January 26, 2017 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
131
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ashford, Australia, 5035
- Novo Nordisk Investigational Site
-
Box Hill, Australia, 3128
- Novo Nordisk Investigational Site
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Novo Nordisk Investigational Site
-
-
-
-
-
Zagreb, Croatia, 10 000
- Novo Nordisk Investigational Site
-
-
-
-
-
Køge, Denmark, 4600
- Novo Nordisk Investigational Site
-
Århus C, Denmark, 8000
- Novo Nordisk Investigational Site
-
-
-
-
-
Citta' Di Castello, Italy, 06012
- Novo Nordisk Investigational Site
-
Perugia, Italy, 06126
- Novo Nordisk Investigational Site
-
-
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7925
- Novo Nordisk Investigational Site
-
-
-
-
-
Linköping, Sweden, 581 85
- Novo Nordisk Investigational Site
-
Trelleborg, Sweden, 231 85
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NPH
|
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
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
|
Experimental: 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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Incidence of total self-recorded hypoglycaemic episodes
|
Secondary Outcome Measures
Outcome Measure |
---|
HbA1c (glycosylated haemoglobin)
|
Incidence of adverse events
|
8-point plasma glucose profiles
|
Incidence of total major hypoglycaemic episodes
|
Serum glucose profiles
|
72-hours glucose profile
|
Within-subject variation in home-measured fasting plasma glucose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
November 1, 2002
Study Completion (Actual)
November 1, 2002
Study Registration Dates
First Submitted
September 28, 2012
First Submitted That Met QC Criteria
September 28, 2012
First Posted (Estimate)
October 2, 2012
Study Record Updates
Last Update Posted (Estimate)
January 27, 2017
Last Update Submitted That Met QC Criteria
January 26, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin Detemir
- Insulin, Isophane
- Isophane Insulin, Human
- Isophane insulin, beef
Other Study ID Numbers
- NN304-1375
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
Clinical Trials on insulin detemir
-
Montefiore Medical CenterCompleted
-
University of AarhusCompletedDiabetes Mellitus, Type 1Denmark
-
Rigshospitalet, DenmarkCompletedWeight Gain | Diabetes Type 2Denmark
-
University of Texas Southwestern Medical CenterNovo Nordisk A/SWithdrawn
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesTaiwan
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2Denmark
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesIndia
-
Institut de Recherches Cliniques de MontrealNovo Nordisk A/S; McMaster UniversityCompleted
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, Puerto Rico