Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes (3L)

This study has been terminated.
(See termination reason in detailed description)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00506662
First received: July 24, 2007
Last updated: June 26, 2012
Last verified: June 2012

July 24, 2007
June 26, 2012
July 2007
December 2008   (final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) at Month 7 [ Time Frame: week 0, month 7 ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 7 months of treatment ]
Complete list of historical versions of study NCT00506662 on ClinicalTrials.gov Archive Site
  • Change in Glycosylated Haemoglobin (HbA1c) at Month 4 [ Time Frame: week 0, month 4 ] [ Designated as safety issue: No ]
  • Change in Mean Fasting Plasma Glucose (FPG) at Month 7 [ Time Frame: week 0, month 7 ] [ Designated as safety issue: No ]
  • Change in Mean Fasting Plasma Glucose (FPG) at Month 4 [ Time Frame: week 0, month 4 ] [ Designated as safety issue: No ]
  • Change in Mean Pre-lunch Plasma Glucose at Month 7 [ Time Frame: week 0, month 7 ] [ Designated as safety issue: No ]
  • Change in Mean Pre-lunch Plasma Glucose at Month 4 [ Time Frame: week 0, month 4 ] [ Designated as safety issue: No ]
  • Change in Mean Pre-dinner Plasma Glucose at Month 7 [ Time Frame: week 0, month 7 ] [ Designated as safety issue: No ]
  • Change in Mean Pre-dinner Plasma Glucose at Month 4 [ Time Frame: week 0, month 4 ] [ Designated as safety issue: No ]
  • Change in Body Weight at Month 7 [ Time Frame: week 0, month 7 ] [ Designated as safety issue: No ]
  • Change in Body Weight at Month 4 [ Time Frame: week 0, month 4 ] [ Designated as safety issue: No ]
  • Mean Number of Total Hypoglycaemic Episodes, Month 1 [ Time Frame: weeks -2-0, month 1 ] [ Designated as safety issue: No ]
    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.
  • Mean Number of Total Hypoglycaemic Episodes, Months 2-4 [ Time Frame: weeks -2-0, months 2-4 ] [ Designated as safety issue: No ]
    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.
  • Mean Number of Total Hypoglycaemic Episodes, Months 5-7 [ Time Frame: weeks -2-0, months 5-7 ] [ Designated as safety issue: No ]
    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.
  • Plasma glucose profiles the last week at 7 months
  • HbA1c at 4 months
  • Plasma glucose profiles the last week at 4 months
Not Provided
Not Provided
 
Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes
The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
    Treat-to-target, s.c. (under the skin) injection, once daily
  • Drug: insulin NPH
    Treat-to-target, s.c. (under the skin) injection, once daily
  • Experimental: Insulin detemir
    Individually adjusted dose of insulin detemir once daily
    Intervention: Drug: insulin detemir
  • Active Comparator: Insulin NPH
    Individually adjusted dose of insulin NPH once daily
    Intervention: Drug: insulin NPH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
86
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   United Kingdom
 
NCT00506662
NN304-1808, 2006-006589-41
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Bertrand Alexandre Novo Nordisk Pharmaceutique S.A.S.
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP