We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00506662
First Posted: July 25, 2007
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Change in Glycosylated Haemoglobin (HbA1c) at Month 4 [ Time Frame: week 0, month 4 ]
  • Change in Mean Fasting Plasma Glucose (FPG) at Month 7 [ Time Frame: week 0, month 7 ]
  • Change in Mean Fasting Plasma Glucose (FPG) at Month 4 [ Time Frame: week 0, month 4 ]
  • Change in Mean Pre-lunch Plasma Glucose at Month 7 [ Time Frame: week 0, month 7 ]
  • Change in Mean Pre-lunch Plasma Glucose at Month 4 [ Time Frame: week 0, month 4 ]
  • Change in Mean Pre-dinner Plasma Glucose at Month 7 [ Time Frame: week 0, month 7 ]
  • Change in Mean Pre-dinner Plasma Glucose at Month 4 [ Time Frame: week 0, month 4 ]
  • Change in Body Weight at Month 7 [ Time Frame: week 0, month 7 ]
  • Change in Body Weight at Month 4 [ Time Frame: week 0, month 4 ]
  • Mean Number of Total Hypoglycaemic Episodes, Month 1 [ Time Frame: weeks -2-0, 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.

  • Mean Number of Total Hypoglycaemic Episodes, Months 2-4 [ Time Frame: weeks -2-0, 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.

  • Mean Number of Total Hypoglycaemic Episodes, Months 5-7 [ Time Frame: weeks -2-0, 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.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00506662     History of Changes
Other Study ID Numbers: NN304-1808
2006-006589-41 ( EudraCT Number )
First Submitted: July 24, 2007
First Posted: July 25, 2007
Results First Submitted: October 19, 2010
Results First Posted: November 17, 2010
Last Update Posted: June 16, 2016
Last Verified: May 2016

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