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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
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin NPH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) at Month 7 [ Time Frame: week 0, month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 86
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir
Individually adjusted dose of insulin detemir once daily
Drug: insulin detemir
Treat-to-target, s.c. (under the skin) injection, once daily
Active Comparator: Insulin NPH
Individually adjusted dose of insulin NPH once daily
Drug: insulin NPH
Treat-to-target, s.c. (under the skin) injection, once daily

Detailed 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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506662

Locations
France
Paris La Défense, France, 92936
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Bertrand Alexandre Novo Nordisk Pharmaceutique S.A.S.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00506662     History of Changes
Other Study ID Numbers: NN304-1808, 2006-006589-41
Study First Received: July 24, 2007
Results First Received: October 19, 2010
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Isophane insulin, beef
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014