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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
insulin detemir
insulin NPH
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin detemir

Insulin NPH

Arm Description

Individually adjusted dose of insulin detemir once daily

Individually adjusted dose of insulin NPH once daily

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) at Month 7

Secondary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c) at Month 4
Change in Mean Fasting Plasma Glucose (FPG) at Month 7
Change in Mean Fasting Plasma Glucose (FPG) at Month 4
Change in Mean Pre-lunch Plasma Glucose at Month 7
Change in Mean Pre-lunch Plasma Glucose at Month 4
Change in Mean Pre-dinner Plasma Glucose at Month 7
Change in Mean Pre-dinner Plasma Glucose at Month 4
Change in Body Weight at Month 7
Change in Body Weight at Month 4
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.
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.
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.

Full Information

First Posted
July 24, 2007
Last Updated
August 10, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00506662
Brief Title
Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes
Acronym
3L
Official Title
The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin detemir
Arm Type
Experimental
Arm Description
Individually adjusted dose of insulin detemir once daily
Arm Title
Insulin NPH
Arm Type
Active Comparator
Arm Description
Individually adjusted dose of insulin NPH once daily
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Treat-to-target, s.c. (under the skin) injection, once daily
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
Treat-to-target, s.c. (under the skin) injection, once daily
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c) at Month 7
Time Frame
week 0, month 7
Secondary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c) at Month 4
Time Frame
week 0, month 4
Title
Change in Mean Fasting Plasma Glucose (FPG) at Month 7
Time Frame
week 0, month 7
Title
Change in Mean Fasting Plasma Glucose (FPG) at Month 4
Time Frame
week 0, month 4
Title
Change in Mean Pre-lunch Plasma Glucose at Month 7
Time Frame
week 0, month 7
Title
Change in Mean Pre-lunch Plasma Glucose at Month 4
Time Frame
week 0, month 4
Title
Change in Mean Pre-dinner Plasma Glucose at Month 7
Time Frame
week 0, month 7
Title
Change in Mean Pre-dinner Plasma Glucose at Month 4
Time Frame
week 0, month 4
Title
Change in Body Weight at Month 7
Time Frame
week 0, month 7
Title
Change in Body Weight at Month 4
Time Frame
week 0, month 4
Title
Mean Number of Total Hypoglycaemic Episodes, Month 1
Description
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.
Time Frame
weeks -2-0, month 1
Title
Mean Number of Total Hypoglycaemic Episodes, Months 2-4
Description
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.
Time Frame
weeks -2-0, months 2-4
Title
Mean Number of Total Hypoglycaemic Episodes, Months 5-7
Description
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.
Time Frame
weeks -2-0, months 5-7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Paris La Défense
ZIP/Postal Code
92936
Country
France
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33166419
Citation
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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