Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.

Detailed Description
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Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.

Official Title
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The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin detemir
* Drug: insulin NPH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes Insulin naive Treatment with oral anti-diabetic drugs (OADs) for at least 3 months and not achieving therapeutic targets HbA1c between 8% - 10.5% Exclusion Criteria: Secondary diabetes, MODY (Maturity Onset Diabetes of the Young) Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator) Proliferative retinopathy, maculopathy requiring treatment, Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD (Modification of Diet in Renal Disease) less than 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months Acute disease with poor prognosis History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE (Mini-Mental State Examination) in the last six months) and any conditions as judged by the investigator Legal incapacity or limited legal capacity (patients under guardianship or curatorship) Concomitant medication for Alzheimers treatment (Memantine, Anticholinesterasique treatment) Participation in another clinical trial less than one month before inclusion in this trial Illness requiring repeated hospitalisation Known or suspected allergy to the insulin or any compositional component Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone) Any other condition that the Investigator feels would interfere with trial participation or evaluation of results Terminal illness

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin detemir<br>Individually adjusted dose of insulin detemir once daily | Drug: insulin detemir<br>* Treat-to-target, s.c. (under the skin) injection, once daily<br>|
| Active Comparator: Insulin NPH<br>Individually adjusted dose of insulin NPH once daily | Drug: insulin NPH<br>* Treat-to-target, s.c. (under the skin) injection, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin (HbA1c) at Month 7 |  | week 0, month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin (HbA1c) at Month 4 |  | week 0, month 4 | 
| Change in Mean Fasting Plasma Glucose (FPG) at Month 7 |  | week 0, month 7 | 
| Change in Mean Fasting Plasma Glucose (FPG) at Month 4 |  | week 0, month 4 | 
| Change in Mean Pre-lunch Plasma Glucose at Month 7 |  | week 0, month 7 | 
| Change in Mean Pre-lunch Plasma Glucose at Month 4 |  | week 0, month 4 | 
| Change in Mean Pre-dinner Plasma Glucose at Month 7 |  | week 0, month 7 | 
| Change in Mean Pre-dinner Plasma Glucose at Month 4 |  | week 0, month 4 | 
| Change in Body Weight at Month 7 |  | week 0, month 7 | 
| Change in Body Weight at Month 4 |  | week 0, month 4 | 
| Mean Number of Total Hypoglycaemic Episodes, Month 1 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | weeks -2-0, month 1 | 
| Mean Number of Total Hypoglycaemic Episodes, Months 2-4 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | weeks -2-0, months 2-4 | 
| Mean Number of Total Hypoglycaemic Episodes, Months 5-7 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | weeks -2-0, months 5-7 |