Trial Outcomes & Findings for Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients (NCT NCT01589653)
NCT ID: NCT01589653
Last Updated: 2017-07-11
Results Overview
Change in HbA1c (%) from baseline to the end of the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
155 participants
Primary outcome timeframe
Week 0, week 20
Results posted on
2017-07-11
Participant Flow
The trial was conducted at 18 sites in 5 countries as follows: Egypt: 4 sites, Indonesia: 2 sites, Morocco: 4 sites, Saudi Arabia: 4 sites, Vietnam: 4 sites.
The subjects continued on their previous NPH insulin and OADs upto randomisation (visit 2). At randomisation, the subjects discontinued these treatments except metformin.
Participant milestones
| Measure |
Subject-driven Titration
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
79
|
|
Overall Study
Exposed
|
76
|
78
|
|
Overall Study
COMPLETED
|
69
|
68
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
Subject-driven Titration
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal criteria
|
4
|
7
|
|
Overall Study
Unclassified
|
0
|
3
|
Baseline Characteristics
Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
Baseline characteristics by cohort
| Measure |
Subject-driven Titration
n=76 Participants
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=79 Participants
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 10.22 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
HbA1c (%)
|
8.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.88 • n=5 Participants
|
8.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.78 • n=7 Participants
|
8.6 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.83 • n=5 Participants
|
|
Fasting plasma glucose (mg/dL)
|
156.8 mg/dL
STANDARD_DEVIATION 59.03 • n=5 Participants
|
148.5 mg/dL
STANDARD_DEVIATION 54.24 • n=7 Participants
|
152.6 mg/dL
STANDARD_DEVIATION 56.64 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) included all randomised subjects.
Change in HbA1c (%) from baseline to the end of the treatment period.
Outcome measures
| Measure |
Subject-driven Titration
n=76 Participants
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=79 Participants
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Change in HbA1c From Baseline
|
-1.27 percentage change in HbA1c
Standard Error 0.11
|
-1.04 percentage change in HbA1c
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). A total of 150 subjects contributed to the analysis.
Change in FPG (laboratory values) from baseline to the end of the treatment period
Outcome measures
| Measure |
Subject-driven Titration
n=75 Participants
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=75 Participants
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline
|
-20.0 mg/dL
Standard Deviation 67.23
|
-9.1 mg/dL
Standard Deviation 62.99
|
SECONDARY outcome
Timeframe: Week 20Population: Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). 154 subjects contributed to the analysis.
The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L \[50 mg/dL\] or plasma glucose level 3.1 mmol/L \[56 mg/dL\]) during the trial.
Outcome measures
| Measure |
Subject-driven Titration
n=76 Participants
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=78 Participants
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Number of Hypoglycaemic Episodes During the Trial From Baseline
|
167 episodes
|
222 episodes
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) included all randomised subjects.
Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0-100 scale with higher scores indicating a better health state.
Outcome measures
| Measure |
Subject-driven Titration
n=74 Participants
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=78 Participants
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Daily life
|
1.9 scores on a scale
Standard Deviation 21.84
|
3.6 scores on a scale
Standard Deviation 20.04
|
|
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Diabetes management
|
12.7 scores on a scale
Standard Deviation 22.79
|
6.9 scores on a scale
Standard Deviation 22.77
|
|
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Compliance
|
7.2 scores on a scale
Standard Deviation 27.69
|
8.9 scores on a scale
Standard Deviation 19.54
|
|
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Psychological health
|
8.4 scores on a scale
Standard Deviation 23.97
|
6.1 scores on a scale
Standard Deviation 21.82
|
|
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Total score
|
8.2 scores on a scale
Standard Deviation 16.52
|
6.6 scores on a scale
Standard Deviation 15.14
|
SECONDARY outcome
Timeframe: Week 0, week 20Population: Full analysis set (FAS) included all randomised subjects.
Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0-100 scale with higher scores indicating a better health state.
Outcome measures
| Measure |
Subject-driven Titration
n=73 Participants
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=78 Participants
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden
|
10.4 scores on a scale
Standard Deviation 21.00
|
8.0 scores on a scale
Standard Deviation 22.90
|
Adverse Events
Subject-driven Titration
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Investigator-driven Titration
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subject-driven Titration
n=76 participants at risk
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=78 participants at risk
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/76 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
1.3%
1/78 • Number of events 1 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/76 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
1.3%
1/78 • Number of events 1 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Infections and infestations
Localised infection
|
0.00%
0/76 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
1.3%
1/78 • Number of events 1 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/76 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
1.3%
1/78 • Number of events 1 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/76 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
1.3%
1/78 • Number of events 1 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
Other adverse events
| Measure |
Subject-driven Titration
n=76 participants at risk
The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
Investigator-driven Titration
n=78 participants at risk
The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
4/76 • Number of events 4 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
6.4%
5/78 • Number of events 5 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
4/76 • Number of events 4 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
2.6%
2/78 • Number of events 2 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
6/76 • Number of events 6 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
6.4%
5/78 • Number of events 7 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Infections and infestations
Influenza
|
7.9%
6/76 • Number of events 6 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
5.1%
4/78 • Number of events 4 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Nervous system disorders
Headache
|
10.5%
8/76 • Number of events 10 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
7.7%
6/78 • Number of events 6 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
2/76 • Number of events 3 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
6.4%
5/78 • Number of events 5 • Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.
Safety analysis set - included all subjects receiving at least one dose of BIAsp 30. Subjects in the safety set will contribute to the evaluation "as treated". Safety analysis set included 154 subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Individual reports by the investigator should not precede the primary manuscript and should always reference the primary manuscript of the trial. Novo Nordisk reserves the right to prior review of such publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.
- Publication restrictions are in place
Restriction type: OTHER