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

Diabetes Mellitus, Type 2 Clinical Trial

— 3L  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00506662
• Other study ID #: NN304-1808
• Secondary ID: 2006-006589-41
• Status: Terminated
• Phase: Phase 4
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Treat-to-target, s.c. (under the skin) injection, once daily
• insulin NPH
Treat-to-target, s.c. (under the skin) injection, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c) at Month 7		week 0, month 7
Secondary	Change in Glycosylated Haemoglobin (HbA1c) at Month 4		week 0, month 4
Secondary	Change in Mean Fasting Plasma Glucose (FPG) at Month 7		week 0, month 7
Secondary	Change in Mean Fasting Plasma Glucose (FPG) at Month 4		week 0, month 4
Secondary	Change in Mean Pre-lunch Plasma Glucose at Month 7		week 0, month 7
Secondary	Change in Mean Pre-lunch Plasma Glucose at Month 4		week 0, month 4
Secondary	Change in Mean Pre-dinner Plasma Glucose at Month 7		week 0, month 7
Secondary	Change in Mean Pre-dinner Plasma Glucose at Month 4		week 0, month 4
Secondary	Change in Body Weight at Month 7		week 0, month 7
Secondary	Change in Body Weight at Month 4		week 0, month 4
Secondary	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
Secondary	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
Secondary	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

External Links

•   Clinical Trials at Novo Nordisk