Trial Outcomes & Findings for Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD) (NCT NCT01825798)
NCT ID: NCT01825798
Last Updated: 2025-07-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Baseline, 16 Weeks
Results posted on
2025-07-16
Participant Flow
Participant milestones
| Measure |
Placebo Hydrochloride Oral Solution
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
28
|
|
Overall Study
COMPLETED
|
30
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Placebo Hydrochloride Oral Solution
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Treatment of Overweight Induced by Antipsychotic Medication in Young People With Autism Spectrum Disorders (ASD)
Baseline characteristics by cohort
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.7 years
STANDARD_DEVIATION 2.64 • n=5 Participants
|
12.9 years
STANDARD_DEVIATION 2.85 • n=7 Participants
|
12.8 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Change in Body Mass Index Z-score
|
0.02 16-wk change in BMI z-score
Interval -0.03 to 0.06
|
-0.08 16-wk change in BMI z-score
Interval -0.13 to -0.04
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Additional Body Composition Parameters (Absolute Change in Weight)
|
2.80 16-wk change in weight (kg)
Interval 1.9 to 3.7
|
0.07 16-wk change in weight (kg)
Interval -0.88 to 1.02
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Additional Body Composition Parameters (Relative Change in Weight)
|
0.04 16-wk change in weight (z-score)
Interval -0.01 to 0.08
|
-0.10 16-wk change in weight (z-score)
Interval -0.15 to -0.05
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Additional Body Composition Parameters (Absolute BMI)
|
0.52 16-wk change in BMI (kg/m2)
Interval 0.18 to 0.87
|
-0.43 16-wk change in BMI (kg/m2)
Interval -0.8 to -0.06
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Additional Body Composition Parameters (Abdominal Circumference)
|
1.45 centimetres
Interval 0.39 to 2.51
|
-0.21 centimetres
Interval -1.32 to 0.91
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Additional Body Composition Parameters (Hip Circumference)
|
1.06 centimetres
Interval -0.06 to 2.17
|
-0.63 centimetres
Interval -1.81 to 0.54
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Fasting Metabolic Parameters (Total Cholesterol)
|
-3.29 16-week change total cholesterol (mg/dL)
Interval -10.33 to 3.75
|
-1.05 16-week change total cholesterol (mg/dL)
Interval -8.76 to 6.67
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Fasting Metabolic Parameters (LDL)
|
-0.41 16-week change in LDL (mg/dL)
Interval -6.11 to 5.29
|
-4.41 16-week change in LDL (mg/dL)
Interval -10.47 to 1.64
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Fasting Metabolic Parameters (HDL)
|
-0.98 16-week change in HDL (mg/dL)
Interval -5.26 to 3.29
|
3.27 16-week change in HDL (mg/dL)
Interval -1.41 to 7.94
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Fasting Metabolic Parameters (Triglycerides)
|
6.18 16-week change in triglycerides (mg/dL)
Interval -19.62 to 31.98
|
5.74 16-week change in triglycerides (mg/dL)
Interval -22.34 to 33.81
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Fasting Metabolic Parameters (Glucose)
|
-2.41 16-week change in gluclose (mg/dL)
Interval -5.76 to 0.94
|
-3.06 16-week change in gluclose (mg/dL)
Interval -6.68 to 0.56
|
SECONDARY outcome
Timeframe: Baseline, 16 WeeksOutcome measures
| Measure |
Placebo Hydrochloride Oral Solution
n=32 Participants
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 Participants
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Changes in Fasting Metabolic Parameters (Insulin)
|
2.95 16-week change insulin fasting (µIU/mL)
Interval -8.44 to 14.35
|
1.97 16-week change insulin fasting (µIU/mL)
Interval -10.44 to 14.38
|
Adverse Events
Placebo Hydrochloride Oral Solution
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Hydrochloride Oral Solution
n=32 participants at risk
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 participants at risk
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Psychiatric disorders
Aggression
|
3.1%
1/32 • Number of events 1
|
0.00%
0/28
|
Other adverse events
| Measure |
Placebo Hydrochloride Oral Solution
n=32 participants at risk
Placebo: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
|
Metformin
n=28 participants at risk
Metformin: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
|
|---|---|---|
|
Ear and labyrinth disorders
Overall
|
9.4%
3/32 • Number of events 4
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
9.4%
3/32 • Number of events 4
|
7.1%
2/28 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.4%
3/32 • Number of events 3
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain, upper
|
12.5%
4/32 • Number of events 4
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Abnormal Feces
|
0.00%
0/32
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Chapped lips
|
6.2%
2/32 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
9.4%
3/32 • Number of events 4
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
40.6%
13/32 • Number of events 19
|
60.7%
17/28 • Number of events 26
|
|
Gastrointestinal disorders
Flatulence
|
9.4%
3/32 • Number of events 4
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 3
|
7.1%
2/28 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
4/32 • Number of events 8
|
28.6%
8/28 • Number of events 9
|
|
Gastrointestinal disorders
Overall
|
59.4%
19/32 • Number of events 55
|
85.7%
24/28 • Number of events 64
|
|
General disorders
Fatigue
|
18.8%
6/32 • Number of events 6
|
21.4%
6/28 • Number of events 8
|
|
General disorders
Irritability
|
21.9%
7/32 • Number of events 7
|
25.0%
7/28 • Number of events 9
|
|
General disorders
Product taste abnormal
|
0.00%
0/32
|
10.7%
3/28 • Number of events 3
|
|
General disorders
Pyrexia
|
3.1%
1/32 • Number of events 2
|
10.7%
3/28 • Number of events 4
|
|
General disorders
Overall
|
43.8%
14/32 • Number of events 18
|
46.4%
13/28 • Number of events 27
|
|
Infections and infestations
Ear Infection
|
3.1%
1/32 • Number of events 1
|
7.1%
2/28 • Number of events 4
|
|
Infections and infestations
Gastroenteritis
|
3.1%
1/32 • Number of events 1
|
10.7%
3/28 • Number of events 4
|
|
Infections and infestations
Otitis media
|
3.1%
1/32 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
34.4%
11/32 • Number of events 11
|
21.4%
6/28 • Number of events 6
|
|
Infections and infestations
Overall
|
59.4%
19/32 • Number of events 25
|
50.0%
14/28 • Number of events 24
|
|
Injury, poisoning and procedural complications
Overall
|
15.6%
5/32 • Number of events 5
|
14.3%
4/28 • Number of events 4
|
|
Investigations
Blood insulin level increased
|
6.2%
2/32 • Number of events 2
|
7.1%
2/28 • Number of events 2
|
|
Investigations
Blood triglyceride level increased
|
6.2%
2/32 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Overall
|
15.6%
5/32 • Number of events 7
|
14.3%
4/28 • Number of events 4
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
12.5%
4/32 • Number of events 4
|
28.6%
8/28 • Number of events 8
|
|
Metabolism and nutrition disorders
Increased Appetite
|
12.5%
4/32 • Number of events 4
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Overall
|
25.0%
8/32 • Number of events 8
|
28.6%
8/28 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
2/32 • Number of events 2
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.1%
1/32 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Overall
|
21.9%
7/32 • Number of events 9
|
14.3%
4/28 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Nervous system disorders
Headache
|
18.8%
6/32 • Number of events 9
|
17.9%
5/28 • Number of events 8
|
|
Nervous system disorders
Somnolence
|
9.4%
3/32 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
Nervous system disorders
Overall
|
31.2%
10/32 • Number of events 16
|
42.9%
12/28 • Number of events 20
|
|
Psychiatric disorders
Affect Lability
|
12.5%
4/32 • Number of events 4
|
0.00%
0/28
|
|
Psychiatric disorders
Aggression
|
6.2%
2/32 • Number of events 3
|
17.9%
5/28 • Number of events 6
|
|
Psychiatric disorders
Anger
|
3.1%
1/32 • Number of events 1
|
14.3%
4/28 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
9.4%
3/32 • Number of events 3
|
3.6%
1/28 • Number of events 1
|
|
Psychiatric disorders
Depressed Mood
|
6.2%
2/32 • Number of events 2
|
0.00%
0/28
|
|
Psychiatric disorders
Initial Insomnia
|
6.2%
2/32 • Number of events 3
|
10.7%
3/28 • Number of events 3
|
|
Psychiatric disorders
Middle Insomnia
|
3.1%
1/32 • Number of events 1
|
7.1%
2/28 • Number of events 2
|
|
Psychiatric disorders
Overall
|
40.6%
13/32 • Number of events 27
|
50.0%
14/28 • Number of events 27
|
|
Reproductive system and breast disorders
Overall
|
6.2%
2/32 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.2%
2/32 • Number of events 2
|
10.7%
3/28 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
12.5%
4/32 • Number of events 4
|
7.1%
2/28 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
9.4%
3/32 • Number of events 4
|
7.1%
2/28 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Overall
|
37.5%
12/32 • Number of events 19
|
28.6%
8/28 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • Number of events 2
|
14.3%
4/28 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Overall
|
25.0%
8/32 • Number of events 8
|
21.4%
6/28 • Number of events 7
|
Additional Information
Dr. Evdokia Anagnostou
Holland Bloorview Kids Rehabilition Hospital
Phone: 416-753-6005
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place