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

August 10, 2023 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c) at Month 4
Time Frame: week 0, month 4
week 0, month 4
Change in Mean Fasting Plasma Glucose (FPG) at Month 7
Time Frame: week 0, month 7
week 0, month 7
Change in Mean Fasting Plasma Glucose (FPG) at Month 4
Time Frame: week 0, month 4
week 0, month 4
Change in Mean Pre-lunch Plasma Glucose at Month 7
Time Frame: week 0, month 7
week 0, month 7
Change in Mean Pre-lunch Plasma Glucose at Month 4
Time Frame: week 0, month 4
week 0, month 4
Change in Mean Pre-dinner Plasma Glucose at Month 7
Time Frame: week 0, month 7
week 0, month 7
Change in Mean Pre-dinner Plasma Glucose at Month 4
Time Frame: week 0, month 4
week 0, month 4
Change in Body Weight at Month 7
Time Frame: week 0, month 7
week 0, month 7
Change in Body Weight at Month 4
Time Frame: week 0, month 4
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.
weeks -2-0, month 1
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.
weeks -2-0, months 2-4
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.
weeks -2-0, months 5-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 24, 2007

First Submitted That Met QC Criteria

July 24, 2007

First Posted (Estimated)

July 25, 2007

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-1808
  • 2006-006589-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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