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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
EUCTR2004-001461-18-ES |
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Date of registration:
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03/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to oral antidiabetic drug(s) in subjects with type 2 diabetes
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Scientific title:
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A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to oral antidiabetic drug(s) in subjects with type 2 diabetes |
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Date of first enrolment:
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07/03/2005 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001461-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
2. Type 2 diabetes according to clinical judgement.
3. Duration of type 2 diabetes =12 months.
4. Insulin naïve subjects. Previous short-term insulin treatment (seven days or less) is allowed.
5. Currently on any oral antidiabetic drug (OAD) = 3 months according to the following:
• Countries where the combination of insulin and TZD is not approved:
? OAD monotherapy, except TZD or alpha-glucosidase inhibitors
? OAD combination therapy, except the combination of TZD and alpha-glucosidase inhibitors
• Countries where the combination of insulin and TZD is approved:
? Any OAD treatment except monotherapy with alpha-glucosidase inhibitors
6. The dose of the individual OAD must be either highest tolerated dose or at least half maximum recommended dose according to local labelling = 3 months prior to screening.
7. The OAD dose(s) must be unchanged for the last month prior to screening.
8. Age = 18 years, females and males.
9. Body mass index (BMI) = 40.0 kg/m2.
10. HbA1c = 7.5 and =11.0% at screening based on analysis from the central laboratory.
11. Able and willing to use daily injections of insulin for the entire trial period.
12. Able and willing to perform self-monitoring of plasma glucose according to the protocol
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Previous participation in this trial. Participation is defined as screened.
2. Previous acute treatment with insulin > 7 days.
3. Treatment with TZD and/or other OAD(s) which does not adhere to the approved labelling for the respective country.
4. Anticipated change in concomitant medication known to interfere with glucose metabolism, such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
5. Proliferative retinopathy or maculopathy that has required acute treatment within the last six months.
6. Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator.
7. Any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial.
8. Uncontrolled hypertension (treated or untreated) as judged by the investigator.
9. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
10. Known or suspected allergy to trial product(s) or related products.
11. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures. Adequate contraceptive measures are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods. In Denmark and France barrier methods are not accepted as adequate contraceptives.
12. The receipt of any investigational drug within one month prior to this trial.
13. Any condition that the Investigator feels would interfere with trial participation or evaluation of results.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
MedDRA version: 7.0
Level: PT
Classification code 10049746
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Intervention(s)
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Trade Name: Levemir
Product Name: Levemir
Product Code: NN304
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
Current Sponsor code: NN304
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
Trade Name: Insulatard FlexPen
Product Name: Insulatard
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Isophane (NPH) Insulin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): Primary endpoint:
• HbA1c after 20 weeks of treatment.
Secondary endpoints:
Efficacy
• Proportion of subjects achieving HbA1c =7.0% after 20 weeks of treatment.
• Proportion of subjects achieving HbA1c =7.0% after 20 weeks of treatment without symptomatic hypoglycaemia with a plasma glucose value < 4.0 mmol/L (< 72 mg/dL) or any single plasma glucose value < 3.1 mmol/L (< 56 mg/dL), in the last four weeks of treatment.
• FPG (central laboratory analysis) after 12 and 20 weeks of treatment.
• Within-subject variation of SMPG before breakfast and dinner at baseline and after eight and 20 weeks of treatment.
• 9-point SMPG profiles during the trial.
Safety
• Incidence of hypoglycaemic episodes (all, minor, major and symptoms only) during the trial; nocturnal (11 pm–6 am) and over the entire day (24 hours).
• Incidence of adverse events during the trial.
• Laboratory assessments (haematology, biochemistry and lipids), fundoscopy/fundusphotography and vital signs after 20 weeks of treatment.
Others
• Body weight change after 20 weeks of treatment.
• Insulin doses during the trial.
• Level of serum insulin and C-peptide in insulin naïve subjects at baseline (Visit 2).
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Main Objective: The primary objective is to compare the glycaemic control, measured as HbA1c, of insulin detemir given once daily with that of NPH insulin given once daily as add-on to current OAD treatment, in subjects with type 2 diabetes after a 20 week treatment period
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Secondary Objective: The following is an abreviated version of the secondary objectives. For further details please refer to the protocol.
If both insulin detemir treatments, insulin detemir given in the morning and insulin detemir given in the evening, are shown to be non-inferior to NPH insulin given once daily with regard to HbA1c, the secondary objective is to compare the glycaemic control, measured as HbA1c, of insulin detemir given in the morning with that of insulin detemir given in the evening, as add-on to OAD(s) after a 20 week treatment period.
If both insulin detemir treatments are shown to be non-inferior to NPH insulin with regard to HbA1c, insulin detemir in the morning will be compared to insulin detemir in the evening in terms of the same parameters as mentioned above
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Secondary ID(s)
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2004-001461-18-IT
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NN304-1632
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 17/02/2005
Contact:
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