Trial Outcomes & Findings for Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes (NCT NCT00506662)
NCT ID: NCT00506662
Last Updated: 2023-08-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
week 0, month 7
Results posted on
2023-08-14
Participant Flow
A total of 57 centres in 2 countries: France (35) and United Kingdom (22)
Subjects in the trial were patients with type 2 diabetes being treated with oral anti-diabetic drug (OAD) therapy(ies) for at least 3 months prior to the trial and considered to benefit from insulin treatment. The randomisation target for this trial was 286.
Participant milestones
| Measure |
Insulin Detemir
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
Individually adjusted dose of insulin NPH once daily
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
48
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
17
|
28
|
Reasons for withdrawal
| Measure |
Insulin Detemir
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
Individually adjusted dose of insulin NPH once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
4
|
|
Overall Study
Trial terminated
|
10
|
16
|
|
Overall Study
Not recorded
|
4
|
6
|
Baseline Characteristics
Comparison of Insulin Detemir and NPH Insulin Given Once Daily in Ageing Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Insulin Detemir
n=38 Participants
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
n=48 Participants
Individually adjusted dose of insulin NPH once daily
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Continuous
|
77.6 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
76.1 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
76.8 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.1 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Duration of diabetes
|
13.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
15.2 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Glycosylated Haemoglobin (HbA1c)
|
9.26 percentage of total haemoglobin
STANDARD_DEVIATION 0.87 • n=5 Participants
|
9.12 percentage of total haemoglobin
STANDARD_DEVIATION 0.78 • n=7 Participants
|
9.19 percentage of total haemoglobin
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Weight
|
77.4 kg
STANDARD_DEVIATION 15.9 • n=5 Participants
|
80.4 kg
STANDARD_DEVIATION 16.4 • n=7 Participants
|
79.0 kg
STANDARD_DEVIATION 16.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 0, month 7Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 4Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 7Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 4Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 7Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 4Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 7Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 4Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 7Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, month 4Population: Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: weeks -2-0, month 1Population: The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.
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.
Outcome measures
| Measure |
Insulin Detemir
n=38 Participants
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
n=48 Participants
Individually adjusted dose of insulin NPH once daily
|
|---|---|---|
|
Mean Number of Total Hypoglycaemic Episodes, Month 1
Screening (week -2 to week 0)
|
0.039 episodes per week by visit
Standard Deviation 0.179
|
0.073 episodes per week by visit
Standard Deviation 0.372
|
|
Mean Number of Total Hypoglycaemic Episodes, Month 1
Month 1 (weeks 1-4)
|
0.026 episodes per week by visit
Standard Deviation 0.097
|
0.120 episodes per week by visit
Standard Deviation 0.282
|
|
Mean Number of Total Hypoglycaemic Episodes, Month 1
Difference (month 1-screening)
|
-0.013 episodes per week by visit
Standard Deviation 0.209
|
0.047 episodes per week by visit
Standard Deviation 0.446
|
SECONDARY outcome
Timeframe: weeks -2-0, months 2-4Population: The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.
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.
Outcome measures
| Measure |
Insulin Detemir
n=38 Participants
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
n=46 Participants
Individually adjusted dose of insulin NPH once daily
|
|---|---|---|
|
Mean Number of Total Hypoglycaemic Episodes, Months 2-4
Screening (week -2 to week 0)
|
0.039 episodes per week by visit
Standard Deviation 0.179
|
0.076 episodes per week by visit
Standard Deviation 0.380
|
|
Mean Number of Total Hypoglycaemic Episodes, Months 2-4
Months 2-4 (weeks 5-16)
|
0.015 episodes per week by visit
Standard Deviation 0.051
|
0.072 episodes per week by visit
Standard Deviation 0.167
|
|
Mean Number of Total Hypoglycaemic Episodes, Months 2-4
Difference (months 2-4 - screening)
|
-0.024 episodes per week by visit
Standard Deviation 0.177
|
-0.004 episodes per week by visit
Standard Deviation 0.394
|
SECONDARY outcome
Timeframe: weeks -2-0, months 5-7Population: The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints.
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.
Outcome measures
| Measure |
Insulin Detemir
n=38 Participants
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
n=43 Participants
Individually adjusted dose of insulin NPH once daily
|
|---|---|---|
|
Mean Number of Total Hypoglycaemic Episodes, Months 5-7
Screening (week -2 to week 0)
|
0.039 episodes per week by visit
Standard Deviation 0.179
|
0.058 episodes per week by visit
Standard Deviation 0.381
|
|
Mean Number of Total Hypoglycaemic Episodes, Months 5-7
Months 5-7 (weeks 17-28)
|
0.018 episodes per week by visit
Standard Deviation 0.078
|
0.041 episodes per week by visit
Standard Deviation 0.099
|
|
Mean Number of Total Hypoglycaemic Episodes, Months 5-7
Difference (months 5-7 - screening)
|
-0.022 episodes per week by visit
Standard Deviation 0.131
|
-0.017 episodes per week by visit
Standard Deviation 0.400
|
Adverse Events
Insulin Detemir
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Insulin NPH
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Detemir
n=38 participants at risk
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
n=48 participants at risk
Individually adjusted dose of insulin NPH once daily
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
2.6%
1/38 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
0.00%
0/48 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
2.6%
1/38 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
0.00%
0/48 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Gastrointestinal disorders
Hiatus hernia
|
2.6%
1/38 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
0.00%
0/48 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
0.00%
0/48 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 1 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
Other adverse events
| Measure |
Insulin Detemir
n=38 participants at risk
Individually adjusted dose of insulin detemir once daily
|
Insulin NPH
n=48 participants at risk
Individually adjusted dose of insulin NPH once daily
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
7.9%
3/38 • Number of events 3 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
0.00%
0/48 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
4/38 • Number of events 5 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
8.3%
4/48 • Number of events 6 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
2/38 • Number of events 2 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
2.1%
1/48 • Number of events 2 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/38 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
6.2%
3/48 • Number of events 3 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Number of events 4 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
6.2%
3/48 • Number of events 3 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
2/38 • Number of events 2 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
0.00%
0/48 • The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Steering Committee has the right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be approved by the Steering Committee, and copies submitted in writing to Novo Nordisk prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER