Trial Outcomes & Findings for Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height) (NCT NCT00303602)
NCT ID: NCT00303602
Last Updated: 2009-06-10
Results Overview
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
149 participants
Primary outcome timeframe
Visit 2 (Baseline) to Visit 7 (16 Weeks)
Results posted on
2009-06-10
Participant Flow
Participant milestones
| Measure |
SODO
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
65
|
|
Overall Study
COMPLETED
|
65
|
50
|
|
Overall Study
NOT COMPLETED
|
19
|
15
|
Reasons for withdrawal
| Measure |
SODO
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Protocol entry criteria not met
|
2
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Noncompliance
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
Baseline characteristics by cohort
| Measure |
SODO
n=84 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=65 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
38.6 years
STANDARD_DEVIATION 13.13 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 12.23 • n=7 Participants
|
38.6 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
18 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
29 participants
n=5 Participants
|
21 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Presence of Metabolic Syndrome
No
|
64 participants
n=5 Participants
|
49 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Presence of Metabolic Syndrome
Yes
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Presence of Metabolic Syndrome
Unknown
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Psychiatric Illness
Schizophrenia
|
46 participants
n=5 Participants
|
36 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Psychiatric Illness
Schizophreniform
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Psychiatric Illness
Schizoaffective disorder
|
3 participants
n=5 Participants
|
12 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Psychiatric Illness
Other related psychiatric disorder
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Psychiatric Illness
Bipolar disorder
|
27 participants
n=5 Participants
|
14 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Race/Ethnicity
African Descent
|
11 participants
n=5 Participants
|
4 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
42 participants
n=5 Participants
|
36 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Race/Ethnicity
East/Southeast Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity
First Nations
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Race/Ethnicity
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Blood Pressure
Systolic Blood Pressure
|
120.3 mm Hg
STANDARD_DEVIATION 16.45 • n=5 Participants
|
119.0 mm Hg
STANDARD_DEVIATION 12.49 • n=7 Participants
|
119.7 mm Hg
STANDARD_DEVIATION 14.82 • n=5 Participants
|
|
Blood Pressure
Diastolic Blood Pressure
|
77.6 mm Hg
STANDARD_DEVIATION 9.62 • n=5 Participants
|
75.8 mm Hg
STANDARD_DEVIATION 9.15 • n=7 Participants
|
76.8 mm Hg
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Body Mass Index
|
28.0 kilograms/meters-squared
STANDARD_DEVIATION 5.63 • n=5 Participants
|
28.3 kilograms/meters-squared
STANDARD_DEVIATION 4.76 • n=7 Participants
|
28.1 kilograms/meters-squared
STANDARD_DEVIATION 5.26 • n=5 Participants
|
|
Clinical Global Impression-Severity Scale
|
3.0 units on a scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 0.85 • n=7 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.81 • n=5 Participants
|
|
Fasting Glucose
|
5.1 millimole/Liter
STANDARD_DEVIATION 0.77 • n=5 Participants
|
5.0 millimole/Liter
STANDARD_DEVIATION 0.46 • n=7 Participants
|
5.1 millimole/Liter
STANDARD_DEVIATION 0.65 • n=5 Participants
|
|
Fasting Insulin
|
13.5 micro International Unit/milliliter
STANDARD_DEVIATION 14.65 • n=5 Participants
|
10.0 micro International Unit/milliliter
STANDARD_DEVIATION 7.18 • n=7 Participants
|
11.9 micro International Unit/milliliter
STANDARD_DEVIATION 12.06 • n=5 Participants
|
|
Fasting Lipoproteins
Total Cholesterol
|
5.1 millimole/Liter
STANDARD_DEVIATION 1.01 • n=5 Participants
|
5.1 millimole/Liter
STANDARD_DEVIATION 1.01 • n=7 Participants
|
5.1 millimole/Liter
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Fasting Lipoproteins
High-Density Lipoprotein Cholesterol
|
1.2 millimole/Liter
STANDARD_DEVIATION 0.40 • n=5 Participants
|
1.3 millimole/Liter
STANDARD_DEVIATION 0.34 • n=7 Participants
|
1.3 millimole/Liter
STANDARD_DEVIATION 0.37 • n=5 Participants
|
|
Fasting Lipoproteins
Low-Density Lipoprotein Cholesterol
|
3.1 millimole/Liter
STANDARD_DEVIATION 0.81 • n=5 Participants
|
3.0 millimole/Liter
STANDARD_DEVIATION 0.88 • n=7 Participants
|
3.1 millimole/Liter
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
Fasting Lipoproteins
Triglycerides
|
1.7 millimole/Liter
STANDARD_DEVIATION 0.77 • n=5 Participants
|
1.7 millimole/Liter
STANDARD_DEVIATION 0.90 • n=7 Participants
|
1.7 millimole/Liter
STANDARD_DEVIATION 0.83 • n=5 Participants
|
|
Global Assessment of Functioning Scale
|
63.4 units on a scale
STANDARD_DEVIATION 12.82 • n=5 Participants
|
62.5 units on a scale
STANDARD_DEVIATION 12.39 • n=7 Participants
|
63.0 units on a scale
STANDARD_DEVIATION 12.60 • n=5 Participants
|
|
Glycosylated Hemoglobin
|
5.5 percent
STANDARD_DEVIATION 0.45 • n=5 Participants
|
5.5 percent
STANDARD_DEVIATION 0.38 • n=7 Participants
|
5.5 percent
STANDARD_DEVIATION 0.42 • n=5 Participants
|
|
Height
|
170.0 centimeters
STANDARD_DEVIATION 10.18 • n=5 Participants
|
168.9 centimeters
STANDARD_DEVIATION 10.23 • n=7 Participants
|
169.5 centimeters
STANDARD_DEVIATION 10.18 • n=5 Participants
|
|
Subjective Appetite (Visual Analog Scale)
|
62.5 units on a scale
STANDARD_DEVIATION 20.85 • n=5 Participants
|
65.7 units on a scale
STANDARD_DEVIATION 19.24 • n=7 Participants
|
63.9 units on a scale
STANDARD_DEVIATION 20.16 • n=5 Participants
|
|
Subjective Well-Being Under Neuroleptic Treatment - Short Form
Total Score
|
85.5 units on a scale
STANDARD_DEVIATION 15.59 • n=5 Participants
|
85.6 units on a scale
STANDARD_DEVIATION 15.00 • n=7 Participants
|
85.5 units on a scale
STANDARD_DEVIATION 15.28 • n=5 Participants
|
|
Subjective Well-Being Under Neuroleptic Treatment - Short Form
Social Integration Subscale
|
17.0 units on a scale
STANDARD_DEVIATION 4.38 • n=5 Participants
|
17.0 units on a scale
STANDARD_DEVIATION 3.97 • n=7 Participants
|
17.0 units on a scale
STANDARD_DEVIATION 4.19 • n=5 Participants
|
|
Subjective Well-Being Under Neuroleptic Treatment - Short Form
Physical Functioning Subscale
|
17.0 units on a scale
STANDARD_DEVIATION 3.53 • n=5 Participants
|
17.2 units on a scale
STANDARD_DEVIATION 3.26 • n=7 Participants
|
17.1 units on a scale
STANDARD_DEVIATION 3.41 • n=5 Participants
|
|
Subjective Well-Being Under Neuroleptic Treatment - Short Form
Mental Functioning Subscale
|
16.7 units on a scale
STANDARD_DEVIATION 4.02 • n=5 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 4.20 • n=7 Participants
|
16.7 units on a scale
STANDARD_DEVIATION 4.09 • n=5 Participants
|
|
Subjective Well-Being Under Neuroleptic Treatment - Short Form
Self-Control Subscale
|
17.0 units on a scale
STANDARD_DEVIATION 3.45 • n=5 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 4.15 • n=7 Participants
|
17.1 units on a scale
STANDARD_DEVIATION 3.76 • n=5 Participants
|
|
Subjective Well-Being Under Neuroleptic Treatment - Short Form
Emotional Regulation Subscale
|
17.6 units on a scale
STANDARD_DEVIATION 4.07 • n=5 Participants
|
17.4 units on a scale
STANDARD_DEVIATION 3.82 • n=7 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 3.95 • n=5 Participants
|
|
Waist Circumference
|
96.1 centimeters
STANDARD_DEVIATION 13.24 • n=5 Participants
|
97.2 centimeters
STANDARD_DEVIATION 12.97 • n=7 Participants
|
96.6 centimeters
STANDARD_DEVIATION 13.09 • n=5 Participants
|
|
Weight
|
81.1 kilograms
STANDARD_DEVIATION 18.97 • n=5 Participants
|
81.2 kilograms
STANDARD_DEVIATION 17.05 • n=7 Participants
|
81.1 kilograms
STANDARD_DEVIATION 18.10 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Baseline) to Visit 7 (16 Weeks)Population: Intention to treat
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.
Outcome measures
| Measure |
SODO
n=82 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=63 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Time Course of Change From Baseline in Body Mass Index (BMI)
Week 16 (N=67, N=51)
|
0.52 kilograms/square meters
Standard Error 0.18
|
0.72 kilograms/square meters
Standard Error 0.20
|
|
Time Course of Change From Baseline in Body Mass Index (BMI)
Week 2 (N=82, N=63)
|
0.09 kilograms/square meters
Standard Error 0.06
|
0.16 kilograms/square meters
Standard Error 0.07
|
|
Time Course of Change From Baseline in Body Mass Index (BMI)
Week 4 (N=79, N=63)
|
0.25 kilograms/square meters
Standard Error 0.08
|
0.27 kilograms/square meters
Standard Error 0.09
|
|
Time Course of Change From Baseline in Body Mass Index (BMI)
Week 8 (N=75, N=58)
|
0.34 kilograms/square meters
Standard Error 0.12
|
0.32 kilograms/square meters
Standard Error 0.13
|
|
Time Course of Change From Baseline in Body Mass Index (BMI)
Week 12 (N=70, N=54)
|
0.47 kilograms/square meters
Standard Error 0.16
|
0.54 kilograms/square meters
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Intention to treat with last observation carried forward
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)
Outcome measures
| Measure |
SODO
n=82 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=63 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)
|
0.52 kilograms/square meters
Standard Deviation 1.49
|
0.67 kilograms/square meters
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (16 Weeks)Population: Per protocol
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.
Outcome measures
| Measure |
SODO
n=60 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=47 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers
|
0.56 kilograms/square meters
Standard Deviation 1.59
|
0.79 kilograms/square meters
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (16 Weeks)Population: Intention to treat
Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.
Outcome measures
| Measure |
SODO
n=67 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=51 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Weight
|
1.42 kilograms
Standard Error 0.50
|
2.08 kilograms
Standard Error 0.57
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Intention to treat with last observation carried forward
Waist circumference is measured on a bare abodomen just above the hip bone.
Outcome measures
| Measure |
SODO
n=76 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=58 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Waist Circumference
|
1.13 centimeters
Standard Deviation 5.25
|
0.77 centimeters
Standard Deviation 5.30
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) to Visit 7 (Week 16)Population: Intention to treat
Percentage loss of body weight = 100\*(postbaseline weight - baseline weight)/baseline weight
Outcome measures
| Measure |
SODO
n=84 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=65 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Up to Week 4 (N=79, N=63)
|
0 participants
|
1 participants
|
|
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Up to Week 8 (N=75, N=58)
|
2 participants
|
2 participants
|
|
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Up to Week 12 (N=70, N=54)
|
3 participants
|
4 participants
|
|
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Up to Week 16 (N=67, N=51)
|
4 participants
|
6 participants
|
|
Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period
Up to Week 2 (N=82, N=63)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) to Visit 7 (Week 16)Population: Intention to treat
The number of participants who discontinued by visit (non-cumulative).
Outcome measures
| Measure |
SODO
n=84 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=65 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Number of Participants Discontinuing the Trial by Visit (Week)
Visit 3 (Week 2) Discontinuations
|
3 participants
|
1 participants
|
|
Number of Participants Discontinuing the Trial by Visit (Week)
Visit 4 (Week 4) Discontinuations
|
3 participants
|
1 participants
|
|
Number of Participants Discontinuing the Trial by Visit (Week)
Visit 5 (Week 8) Discontinuations
|
5 participants
|
6 participants
|
|
Number of Participants Discontinuing the Trial by Visit (Week)
Visit 6 (Week 12) Discontinuations
|
5 participants
|
6 participants
|
|
Number of Participants Discontinuing the Trial by Visit (Week)
Visit 7 (Week 16) Discontinuations
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Intention to treat
Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.
Outcome measures
| Measure |
SODO
n=82 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=63 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale
|
-8.21 units on a scale
Standard Error 2.26
|
-5.02 units on a scale
Standard Error 2.59
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Safety population with last observation carried forward
Sitting blood pressure, taken from the same arm.
Outcome measures
| Measure |
SODO
n=74 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=55 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
Systolic Blood Pressure
|
0.1 mm Hg
Standard Deviation 11.62
|
-0.1 mm Hg
Standard Deviation 10.83
|
|
Mean Change From Baseline to 16 Week Endpoint in Blood Pressure
Diastolic Blood Pressure
|
0.3 mm Hg
Standard Deviation 7.55
|
0.8 mm Hg
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Safety population with last observation carried forward
Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.
Outcome measures
| Measure |
SODO
n=74 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=57 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
Total Cholesterol
|
0.1 millimole/Liter
Standard Deviation 0.74
|
0.2 millimole/Liter
Standard Deviation 0.79
|
|
Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
High-Density Lipoprotein Cholesterol
|
-0.0 millimole/Liter
Standard Deviation 0.24
|
-0.0 millimole/Liter
Standard Deviation 0.24
|
|
Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
Low-Density Lipoprotein Cholesterol (N=73, N=57)
|
0.1 millimole/Liter
Standard Deviation 0.66
|
0.2 millimole/Liter
Standard Deviation 0.53
|
|
Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)
Triglycerides
|
0.1 millimole/Liter
Standard Deviation 0.84
|
0.0 millimole/Liter
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Safety population with last observation carried forward
Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.
Outcome measures
| Measure |
SODO
n=75 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=57 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose
|
0.2 millimole/Liter
Standard Deviation 0.79
|
0.1 millimole/Liter
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Safety population with last observation carried forward
Patients should be fasting a minimum of eight hours prior to serum insulin measurement.
Outcome measures
| Measure |
SODO
n=65 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=52 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin
|
2.4 microIU/milliliter
Standard Deviation 17.72
|
-0.1 microIU/milliliter
Standard Deviation 5.52
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Safety population with last observation carried forward
Outcome measures
| Measure |
SODO
n=75 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=57 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin
|
0.0 percent
Standard Deviation 0.24
|
0.0 percent
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Safety population with last observation carried forward.
HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.
Outcome measures
| Measure |
SODO
n=59 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=46 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)
|
-18.5 percent sensitivity
Standard Deviation 58.91
|
-9.8 percent sensitivity
Standard Deviation 62.61
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Intention to treat
Patient meets definition of metabolic syndrome if they have \>=3 risk factors: Waist circumference (men\>102cm, women\>88cm); triglycerides \>=1.7mmol/L; HDL cholesterol (men\<1.04mmol/L, women\<1.30mmol/L); blood pressure \>135/\>=85 mmHg; Fasting glucose \>=6.1mmol/L
Outcome measures
| Measure |
SODO
n=84 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=65 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint
Baseline - Metabolic Syndrome (N=82, N=65)
|
18 participants
|
16 participants
|
|
Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint
Endpoint - Metabolic Syndrome (N=70, N=52)
|
18 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Intention to treat
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Outcome measures
| Measure |
SODO
n=67 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=51 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale
|
-0.26 units on a scale
Standard Error 0.07
|
-0.09 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Intention to treat
Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.
Outcome measures
| Measure |
SODO
n=65 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=49 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale
|
4.79 units on a scale
Standard Error 1.52
|
1.60 units on a scale
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline) and Visit 7 (Week 16)Population: Intention to treat
Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).
Outcome measures
| Measure |
SODO
n=67 Participants
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
n=51 Participants
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale
|
4.61 units on a scale
Standard Error 1.05
|
2.72 units on a scale
Standard Error 1.20
|
Adverse Events
SODO
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
SOT
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SODO
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Psychiatric disorders
Suicide attempt
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
Other adverse events
| Measure |
SODO
Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
|
SOT
Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
|
|---|---|---|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Eye disorders
Dry eye
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.6%
3/84 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
1/84 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/84 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Tongue spasm
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Tooth fracture
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/84 • Number of events 2
|
0.00%
0/65
|
|
General disorders
Asthenia
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
General disorders
Fatigue
|
3.6%
3/84 • Number of events 4
|
7.7%
5/65 • Number of events 6
|
|
General disorders
Tenderness
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Eye infection
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Influenza
|
0.00%
0/84
|
3.1%
2/65 • Number of events 2
|
|
Infections and infestations
Localised infection
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/84 • Number of events 1
|
4.6%
3/65 • Number of events 3
|
|
Injury, poisoning and procedural complications
Sunburn
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Investigations
Blood potassium decreased
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Investigations
Blood triglycerides increased
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Investigations
Weight increased
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
3/84 • Number of events 3
|
0.00%
0/65
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Metabolism and nutrition disorders
Increased appetite
|
10.7%
9/84 • Number of events 9
|
15.4%
10/65 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/84
|
3.1%
2/65 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Akathisia
|
2.4%
2/84 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/84
|
6.2%
4/65 • Number of events 4
|
|
Nervous system disorders
Headache
|
6.0%
5/84 • Number of events 6
|
7.7%
5/65 • Number of events 5
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/84 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Sedation
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
6.0%
5/84 • Number of events 5
|
7.7%
5/65 • Number of events 6
|
|
Nervous system disorders
Syncope
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
Tongue paralysis
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Nervous system disorders
Tremor
|
1.2%
1/84 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
3.6%
3/84 • Number of events 3
|
3.1%
2/65 • Number of events 3
|
|
Psychiatric disorders
Depression
|
3.6%
3/84 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
2.4%
2/84 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
|
Psychiatric disorders
Irritability
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Psychiatric disorders
Libido decreased
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Psychiatric disorders
Psychomotor agitation
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Psychiatric disorders
Psychotic disorder
|
1.2%
1/84 • Number of events 1
|
0.00%
0/65
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Polyuria
|
1.2%
1/84 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
|
Vascular disorders
Haematoma
|
0.00%
0/84
|
1.5%
1/65 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60