Trial Outcomes & Findings for A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin (NCT NCT02131272)
NCT ID: NCT02131272
Last Updated: 2018-09-10
Results Overview
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
42 participants
Primary outcome timeframe
week 0, week 26
Results posted on
2018-09-10
Participant Flow
The following 12 countries screened subjects (no. of sites that randomised subjects within parentheses): Brazil (1), Germany (1), India (3), Israel (1), South Korea (1), Malaysia (3), Mexico (1), Russian Federation (1) Taiwan (3), Turkey (3), United States (6), Hungary (0). A total of 24 sites in 11 countries randomised subjects to treatment.
Subjects continued treatment with metformin on their pre-study dose(s) throughout the trial.
Participant milestones
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Overall Study
Withdrawal by parent
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Withdrawal Criteria
|
1
|
0
|
Baseline Characteristics
A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
Baseline characteristics by cohort
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.0 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
15.0 Years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
15.0 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.72 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.86 • n=5 Participants
|
8.95 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.05 • n=7 Participants
|
8.84 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
Body weight standard deviation score
|
1.532 standard deviation score
STANDARD_DEVIATION 0.685 • n=5 Participants
|
1.260 standard deviation score
STANDARD_DEVIATION 0.835 • n=7 Participants
|
1.390 standard deviation score
STANDARD_DEVIATION 0.771 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 0, week 26Population: Full analysis set included all the randomised subjects.
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
Outcome measures
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Change in HbA1c (Glycosylated Haemoglobin)
|
-0.64 Percentage of glycosylated haemoglobin
Standard Error 0.32
|
-0.81 Percentage of glycosylated haemoglobin
Standard Error 0.31
|
SECONDARY outcome
Timeframe: week 0, week 26Population: Full analysis set included all the randomised subjects.
Change in body weight standard deviation score (SDS) from baseline to week 26. In order to reduce the variability in body weight measurements, SDS were calculated. SDS for weight was derived by comparing the actual measurements with standard growth charts for the United States. Standard values provided by the standard growth charts according to the subject's sex and age at the time of the measurement were used to calculate the SDS.
Outcome measures
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Change in Body Weight Standard Deviation Score (SDS)
|
0.006 standard deviation score
Standard Deviation 0.192
|
0.098 standard deviation score
Standard Deviation 0.139
|
SECONDARY outcome
Timeframe: At week 26Population: Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).
Proportion of subjects achieving HbA1c \<7.0% is presented as percentage of subjects achieving HbA1c \<7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.
Outcome measures
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=21 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.
|
25.0 Percentage of subjects
|
33.3 Percentage of subjects
|
SECONDARY outcome
Timeframe: At week 26Population: Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).
Proportion of subjects achieving HbA1c below 7.5% is presented as percentage of subjects achieving HbA1c \<7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.
Outcome measures
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=21 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment
|
30.0 Percentage of subjects
|
38.1 Percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 0 - 26Population: Safety analysis set included all subjects receiving at least one dose of randomised treatment.
The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value \<3.1 mmol/L \[56 mg/dL\] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.
Outcome measures
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Severe
|
0 Number of episodes
|
0 Number of episodes
|
|
Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Blood glucose confirmed symptomatic
|
0 Number of episodes
|
1 Number of episodes
|
SECONDARY outcome
Timeframe: Weeks 0 - 26Population: Safety analysis set included all subjects receiving at least one dose of randomised treatment.
Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value \<3.1 mmol/L \[56 mg/dL\] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.
Outcome measures
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Severe
|
0 Number of episodes
|
0 Number of episodes
|
|
Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Blood glucose confirmed symptomatic
|
4 Number of episodes
|
12 Number of episodes
|
SECONDARY outcome
Timeframe: weeks 0 - 26Population: Safety analysis set included all subjects receiving at least one dose of randomised treatment.
The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment.
Outcome measures
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 Participants
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 Participants
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Incidence of Adverse Events (AEs)
|
30 Number of events
|
41 Number of events
|
Adverse Events
Insulin Detemir + Metformin + Diet/Exercise
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Insulin NPH + Metformin + Diet/Exercise
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 participants at risk
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 participants at risk
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Nervous system disorders
Migraine
|
0.00%
0/20 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
4.5%
1/22 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
Other adverse events
| Measure |
Insulin Detemir + Metformin + Diet/Exercise
n=20 participants at risk
Subjects were treated with insulin detemir 100 U/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin detemir was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin detemir unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
Insulin NPH + Metformin + Diet/Exercise
n=22 participants at risk
Subjects were treated with NPH 100 IU/mL administered subcutaneously in the thigh region once or twice daily for a period of 26 weeks. For insulin naïve subjects, insulin NPH was initiated at a dose of 0.1-0.2 U/kg with a maximum dose of 10 U at the investigators discretion. Subjects who were already on basal insulin were switched to insulin NPH unit-to-unit once or twice daily, depending on previous injection frequency. Subjects were dosed according to individual requirements during the trial period. All subjects continued treatment with metformin on their pre-study dose(s) throughout the trial. The diet/exercise intervention was performed through changes in eating and activity behaviours.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
4.5%
1/22 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Infections and infestations
Gastroenteritis
|
10.0%
2/20 • Number of events 2 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Infections and infestations
Gastroenteritis viral
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • Number of events 4 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
4.5%
1/22 • Number of events 4 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Infections and infestations
Impetigo
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
9.1%
2/22 • Number of events 3 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
General disorders
Injection site erythema
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Gastrointestinal disorders
Lip dry
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
9.1%
2/22 • Number of events 2 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
13.6%
3/22 • Number of events 3 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 4 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
General disorders
Pyrexia
|
10.0%
2/20 • Number of events 2 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
9.1%
2/22 • Number of events 2 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
4.5%
1/22 • Number of events 2 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 2 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Infections and infestations
Viral infection
|
5.0%
1/20 • Number of events 1 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 4 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
0.00%
0/22 • Adverse events from the first trial-related activity (week -2) after the subject and/or his/her legally acceptable representative has signed the informed consent until the end of the trial (week 26).
Safety analysis set included all subjects receiving at least one dose of randomised treatment. A treatment emergent adverse event was defined as an event that had the onset date on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER