Trial Outcomes & Findings for BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in Subjects With Pre-Diabetes (NCT NCT02358668)
NCT ID: NCT02358668
Last Updated: 2017-04-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
From baseline to Week 4
Results posted on
2017-04-25
Participant Flow
The study was conducted at the Diabetes and Endocrine Research Centre, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR.
77 subjects were screened and 60 subjects met the eligibility criteria to be randomized.
Participant milestones
| Measure |
BTI320 4 Grams
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
12
|
|
Overall Study
COMPLETED
|
22
|
23
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
BTI320 4 Grams
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in Subjects With Pre-Diabetes
Baseline characteristics by cohort
| Measure |
BTI320 4 Grams
n=24 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=24 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Region of Enrollment
Hong Kong
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
12 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Body weight
|
74.2 kg
STANDARD_DEVIATION 16.9 • n=5 Participants
|
71.0 kg
STANDARD_DEVIATION 16.2 • n=7 Participants
|
63.9 kg
STANDARD_DEVIATION 20.0 • n=5 Participants
|
70.9 kg
STANDARD_DEVIATION 17.4 • n=4 Participants
|
|
Body mass index
|
28.0 kg/m2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
26.9 kg/m2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
25.1 kg/m2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
27.0 kg/m2
STANDARD_DEVIATION 5.0 • n=4 Participants
|
|
Waist circumference
|
95.0 cm
STANDARD_DEVIATION 15.6 • n=5 Participants
|
90.6 cm
STANDARD_DEVIATION 9.1 • n=7 Participants
|
88.0 cm
STANDARD_DEVIATION 15.7 • n=5 Participants
|
91.8 cm
STANDARD_DEVIATION 13.5 • n=4 Participants
|
|
Systolic blood pressure
|
121.7 mmHg
STANDARD_DEVIATION 13.2 • n=5 Participants
|
125.4 mmHg
STANDARD_DEVIATION 16.2 • n=7 Participants
|
127.8 mmHg
STANDARD_DEVIATION 8.7 • n=5 Participants
|
124.0 mmHg
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
Diastolic blood pressure
|
78.4 mmHg
STANDARD_DEVIATION 6.8 • n=5 Participants
|
78.7 mmHg
STANDARD_DEVIATION 7.2 • n=7 Participants
|
80.4 mmHg
STANDARD_DEVIATION 7.3 • n=5 Participants
|
78.9 mmHg
STANDARD_DEVIATION 7.0 • n=4 Participants
|
|
Fructosamine
|
268.5 umol/L
STANDARD_DEVIATION 18.3 • n=5 Participants
|
272.2 umol/L
STANDARD_DEVIATION 20.2 • n=7 Participants
|
278.9 umol/L
STANDARD_DEVIATION 22.0 • n=5 Participants
|
272.1 umol/L
STANDARD_DEVIATION 19.9 • n=4 Participants
|
|
HbA1c
|
6.0 %
STANDARD_DEVIATION 0.3 • n=5 Participants
|
6.0 %
STANDARD_DEVIATION 0.3 • n=7 Participants
|
6.1 %
STANDARD_DEVIATION 0.3 • n=5 Participants
|
6.0 %
STANDARD_DEVIATION 0.3 • n=4 Participants
|
|
Total cholesterol
|
4.9 mmol/L
STANDARD_DEVIATION 1.1 • n=5 Participants
|
4.9 mmol/L
STANDARD_DEVIATION 1.0 • n=7 Participants
|
5.3 mmol/L
STANDARD_DEVIATION 0.8 • n=5 Participants
|
5.0 mmol/L
STANDARD_DEVIATION 1.0 • n=4 Participants
|
|
Impaired fasting glucose
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Impaired glucose tolerance
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
5 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Impaired fasting glucose and impaired glucose tolerance
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Normal glucose tolerance
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
1-hour post-prandial glucose AUC
|
5.91 mmol/L*hour
STANDARD_DEVIATION 0.53 • n=5 Participants
|
6.22 mmol/L*hour
STANDARD_DEVIATION 0.72 • n=7 Participants
|
6.33 mmol/L*hour
STANDARD_DEVIATION 0.64 • n=5 Participants
|
6.12 mmol/L*hour
STANDARD_DEVIATION 0.65 • n=4 Participants
|
|
2-hour post-prandial glucose AUC
|
12.68 mmol/L*hour
STANDARD_DEVIATION 1.21 • n=5 Participants
|
13.64 mmol/L*hour
STANDARD_DEVIATION 1.87 • n=7 Participants
|
13.49 mmol/L*hour
STANDARD_DEVIATION 1.43 • n=5 Participants
|
13.22 mmol/L*hour
STANDARD_DEVIATION 1.59 • n=4 Participants
|
|
3-hour post-prandial glucose AUC
|
18.90 mmol/L*hour
STANDARD_DEVIATION 1.69 • n=5 Participants
|
20.20 mmol/L*hour
STANDARD_DEVIATION 2.59 • n=7 Participants
|
20.20 mmol/L*hour
STANDARD_DEVIATION 2.20 • n=5 Participants
|
19.68 mmol/L*hour
STANDARD_DEVIATION 2.25 • n=4 Participants
|
|
72 hour AUC-180
|
0.40 mmol/L*hour
STANDARD_DEVIATION 1.85 • n=5 Participants
|
1.71 mmol/L*hour
STANDARD_DEVIATION 3.35 • n=7 Participants
|
2.73 mmol/L*hour
STANDARD_DEVIATION 7.64 • n=5 Participants
|
1.39 mmol/L*hour
STANDARD_DEVIATION 4.17 • n=4 Participants
|
|
Mean blood glucose
|
6.01 mmol/L
STANDARD_DEVIATION 0.45 • n=5 Participants
|
6.20 mmol/L
STANDARD_DEVIATION 0.63 • n=7 Participants
|
6.45 mmol/L
STANDARD_DEVIATION 0.54 • n=5 Participants
|
6.18 mmol/L
STANDARD_DEVIATION 0.56 • n=4 Participants
|
|
Mean post-meal maximum glucose
|
7.45 mmol/L
STANDARD_DEVIATION 0.75 • n=5 Participants
|
8.20 mmol/L
STANDARD_DEVIATION 1.31 • n=7 Participants
|
8.07 mmol/L
STANDARD_DEVIATION 1.00 • n=5 Participants
|
7.88 mmol/L
STANDARD_DEVIATION 1.09 • n=4 Participants
|
|
Mean amplitude of glucose excursion
|
2.06 mmol/L
STANDARD_DEVIATION 0.69 • n=5 Participants
|
2.68 mmol/L
STANDARD_DEVIATION 1.01 • n=7 Participants
|
3.21 mmol/L
STANDARD_DEVIATION 3.16 • n=5 Participants
|
2.55 mmol/L
STANDARD_DEVIATION 1.63 • n=4 Participants
|
|
Percentage coefficient of variation
|
15.49 %
STANDARD_DEVIATION 4.43 • n=5 Participants
|
19.07 %
STANDARD_DEVIATION 6.61 • n=7 Participants
|
18.00 %
STANDARD_DEVIATION 7.60 • n=5 Participants
|
17.46 %
STANDARD_DEVIATION 6.20 • n=4 Participants
|
|
Standard deviation
|
0.93 mmol/L
STANDARD_DEVIATION 0.28 • n=5 Participants
|
1.19 mmol/L
STANDARD_DEVIATION 0.44 • n=7 Participants
|
1.18 mmol/L
STANDARD_DEVIATION 0.59 • n=5 Participants
|
1.09 mmol/L
STANDARD_DEVIATION 0.43 • n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 4Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320.
Outcome measures
| Measure |
BTI320 4 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=24 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
|
-5.2 umol/L
Standard Deviation 14.1
|
-9.4 umol/L
Standard Deviation 8.9
|
-8.8 umol/L
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in 3-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system from baseline to Week 16. Note that this is not a pharmacokinetic study and this is not pharmacokinetic data as we are not measuring drug levels. Here we are examining glucose levels after meals as one of the anticipated glycemic outcomes of using glucose-lowering therapy (BTI320 in this case). With data-analysis based on continuous glucose monitoring, it is conventional to present post-prandial (i.e. post-meal) glucose incremental area under curve at up to 3 hours. It is not meaningful to look at post-meal glucose changes at more than 3 hours after meal for the obvious reason that subject might have taken another meal by then.
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System
|
0.07 mmol/L*hour
Standard Deviation 1.99
|
-0.65 mmol/L*hour
Standard Deviation 1.93
|
-0.68 mmol/L*hour
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose BTI320 and High Dose BTI320 Compared With Placebo in Mean Post-meal Maximum Glucose on Continuous Glucose Monitoring System
|
0.13 mmol/L
Standard Deviation 0.99
|
-0.36 mmol/L
Standard Deviation 0.87
|
-0.14 mmol/L
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=20 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Amplitude of Glucose Excursion on Continuous Glucose Monitoring System
|
-0.04 mmol/L
Standard Deviation 0.77
|
-0.48 mmol/L
Standard Deviation 0.88
|
-0.92 mmol/L
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=16 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=11 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose on Continuous Glucose Monitoring System
|
-0.01 mmol/L
Standard Deviation 0.52
|
-0.06 mmol/L
Standard Deviation 0.50
|
-0.32 mmol/L
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Area under curve for glucose levels \>180 mg/dL over 72 hours
Outcome measures
| Measure |
BTI320 4 Grams
n=16 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=11 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve for Glucose Levels >180mg/dL on Continuous Glucose Monitoring System
|
-0.19 mmol/L*hour
Standard Deviation 2.58
|
-1.67 mmol/L*hour
Standard Deviation 3.51
|
-1.38 mmol/L*hour
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=16 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=11 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System
|
-0.09 mmol/L
Standard Deviation 0.32
|
-0.23 mmol/L
Standard Deviation 0.31
|
-0.14 mmol/L
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=16 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=11 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System
|
-1.6 % of coefficient of variation
Standard Deviation 4.4
|
-3.5 % of coefficient of variation
Standard Deviation 4.5
|
-1.1 % of coefficient of variation
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
|
-0.01 percent glycated hemoglobin
Standard Deviation 0.19
|
-0.02 percent glycated hemoglobin
Standard Deviation 0.16
|
-0.04 percent glycated hemoglobin
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
|
-5.0 umol/L
Standard Deviation 18.6
|
-6.8 umol/L
Standard Deviation 12.0
|
-9.8 umol/L
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in area under curve of glucose from 0 minute to 120 minutes from baseline to Week 16
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Glucose During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
|
-63.6 mmol/L*minute
Standard Deviation 103.9
|
-24.5 mmol/L*minute
Standard Deviation 132.2
|
-84.9 mmol/L*minute
Standard Deviation 150.4
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in area under curve of insulin from 0 minute to 120 minutes from baseline to Week 16
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Insulin During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
|
-1533.7 mIU/L*minute
Standard Deviation 3171.6
|
-382.8 mIU/L*minute
Standard Deviation 2781.6
|
-1225.8 mIU/L*minute
Standard Deviation 3922.9
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in area under curve of C-peptide from 0 minute to 120 minutes from baseline to Week 16
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of C-peptide During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
|
-56.2 ug/L*minute
Standard Deviation 193.1
|
-22.9 ug/L*minute
Standard Deviation 170.9
|
-120.8 ug/L*minute
Standard Deviation 257.8
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in area under curve of glucagon-like peptide-1 from 0 minute to 120 minutes from baseline to Week 16
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Glucagon-like Peptide 1 During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
|
117.0 pmol/L*minute
Standard Deviation 340.6
|
130.9 pmol/L*minute
Standard Deviation 514.1
|
107.9 pmol/L*minute
Standard Deviation 197.4
|
SECONDARY outcome
Timeframe: From baseline to 30 days post-treatmentPopulation: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Proportion of subjects with impaired fasting glucose, impaired glucose tolerance, both impaired fasting glucose and impaired glucose tolerance, HbA1c 5.7-6.4%, or type 2 diabetes at 30 days post-treatment
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group
|
100 percentage of subjects
|
95.7 percentage of subjects
|
100 percentage of subjects
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in systolic blood pressures from baseline to Week 16
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-0.5 mmHg
Standard Deviation 10.6
|
-0.7 mmHg
Standard Deviation 13.5
|
-3.5 mmHg
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-2.5 cm
Standard Deviation 3.4
|
-1.5 cm
Standard Deviation 3.4
|
-1.8 cm
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-1.7 kg
Standard Deviation 2.4
|
-0.5 kg
Standard Deviation 1.9
|
-0.1 kg
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in total cholesterol from baseline to Week 16.
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-0.0 mmol/L
Standard Deviation 0.75
|
-0.2 mmol/L
Standard Deviation 0.56
|
-0.15 mmol/L
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo
|
-0.85 mg/L
Standard Deviation 5.78
|
0.09 mg/L
Standard Deviation 2.00
|
-0.89 mg/L
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Urate in Subjects Treated With High Dose and Lose Dose BTI320 Compared to Placebo
|
-0.008 mmol/L
Standard Deviation 0.054
|
0.006 mmol/L
Standard Deviation 0.053
|
-0.015 mmol/L
Standard Deviation 0.036
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in WHOQOL-BREF physical health domain score from baseline to Week 16. This is a sub-scale of the WHOQOL-BREF. Possible scores range from minimal of 4 to maximum of 20. Higher score indicate better physical health domain.
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Quality of Life Measures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-0.6 units on a scale
Standard Deviation 1.4
|
0.0 units on a scale
Standard Deviation 1.3
|
0.1 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes to question of "how full do you feel" in the Appetite Questionnaire adopted from Hill and Blundell from baseline and Week 16. Scale score ranges from minimum of 0 to maximum of 10. 10 being the most full and 0 being the least full.
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-0.4 units on a scale
Standard Deviation 2.7
|
1.0 units on a scale
Standard Deviation 3.2
|
1.3 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in daily calories intake from baseline to Week 16
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Measures of Nutritional Intake in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-237.4 kcal
Standard Deviation 358.8
|
-75.0 kcal
Standard Deviation 486.2
|
-320.9 kcal
Standard Deviation 794.8
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Changes in the number of days per week that the subject spent walking for at least 10 minutes from baseline to Week 16
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Measures of Exercise in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-0.1 Days
Standard Deviation 1.7
|
-0.5 Days
Standard Deviation 2.1
|
0.2 Days
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 1 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.11 mmol/L*hour
Interval -0.18 to 0.41
|
-0.07 mmol/L*hour
Interval -0.33 to 0.19
|
-0.15 mmol/L*hour
Interval -0.49 to 0.2
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 2 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.08 mmol/L*hour
Interval -0.62 to 0.78
|
-0.51 mmol/L*hour
Interval -1.1 to 0.08
|
-0.31 mmol/L*hour
Interval -0.92 to 0.31
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 3 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.14 mmol/L*hour
Interval -0.85 to 1.14
|
-0.68 mmol/L*hour
Interval -1.51 to 0.14
|
-0.69 mmol/L*hour
Interval -1.59 to 0.21
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 1 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.12 mmol/L
Interval -0.2 to 0.44
|
-0.08 mmol/L
Interval -0.36 to 0.2
|
-0.16 mmol/L
Interval -0.53 to 0.22
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 2 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.12 mmol/L
Interval -0.24 to 0.48
|
-0.19 mmol/L
Interval -0.49 to 0.11
|
-0.08 mmol/L
Interval -0.42 to 0.26
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 3 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.15 mmol/L
Interval -0.19 to 0.48
|
-0.14 mmol/L
Interval -0.4 to 0.12
|
-0.04 mmol/L
Interval -0.34 to 0.25
|
SECONDARY outcome
Timeframe: From baseline to Week 16Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
|
-0.05 mmol/L
Interval -0.27 to 0.17
|
-0.05 mmol/L
Interval -0.26 to 0.16
|
-0.16 mmol/L
Interval -0.38 to 0.06
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Post-prandial Maximum Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.15 mmol/L
Interval -0.34 to 0.64
|
-0.38 mmol/L
Interval -0.75 to 0.0
|
-0.14 mmol/L
Interval -0.51 to 0.23
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Maximum Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.10 mmol/L
Interval -0.38 to 0.58
|
-0.52 mmol/L
Interval -0.91 to -0.12
|
-0.35 mmol/L
Interval -0.82 to 0.12
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.00 mmol/L
Interval -0.15 to 0.15
|
-0.18 mmol/L
Interval -0.31 to -0.05
|
-0.05 mmol/L
Interval -0.19 to 0.09
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.02 mmol/L
Interval -0.12 to 0.16
|
-0.13 mmol/L
Interval -0.25 to 0.0
|
-0.01 mmol/L
Interval -0.13 to 0.11
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
|
0.01 mmol/L
Interval -0.13 to 0.15
|
-0.12 mmol/L
Interval -0.23 to -0.01
|
-0.02 mmol/L
Interval -0.14 to 0.09
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
|
-0.05 mmol/L
Interval -0.2 to 0.1
|
-0.20 mmol/L
Interval -0.33 to -0.07
|
-0.18 mmol/L
Interval -0.61 to 0.25
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
|
-0.26 % of coefficient of variation
Interval -1.99 to 1.47
|
-2.46 % of coefficient of variation
Interval -4.03 to -0.9
|
-0.60 % of coefficient of variation
Interval -2.18 to 0.98
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
|
-0.06 % of coefficient of variation
Interval -1.54 to 1.42
|
-1.28 % of coefficient of variation
Interval -2.71 to 0.16
|
-0.01 % of coefficient of variation
Interval -1.67 to 1.65
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
|
-0.18 % of coefficient of variation
Interval -1.73 to 1.38
|
-1.37 % of coefficient of variation
Interval -2.67 to -0.08
|
-0.33 % of coefficient of variation
Interval -1.93 to 1.27
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=21 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
|
-0.84 % of coefficient of variation
Interval -2.99 to 1.31
|
-3.04 % of coefficient of variation
Interval -4.95 to -1.13
|
-2.68 % of coefficient of variation
Interval -10.09 to 4.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Serum Creatinine in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-4.3 umol/L
Standard Deviation 7.0
|
-3.5 umol/L
Standard Deviation 8.5
|
-7.0 umol/L
Standard Deviation 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 4, Week 8, Week 12, and Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320.
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Measures of Liver Function in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
2.6 IU/L
Standard Deviation 12.5
|
1.4 IU/L
Standard Deviation 8.5
|
-0.9 IU/L
Standard Deviation 10.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 4, Week 8, Week 12, and Week 16Population: Intention to treat, as defined by all subjects who have received at least one dose of BTI320
Outcome measures
| Measure |
BTI320 4 Grams
n=22 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=23 Participants
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 Participants
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Changes in Complete Blood Count in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
|
-0.3 g/dL
Standard Deviation 0.4
|
-0.4 g/dL
Standard Deviation 0.5
|
-0.4 g/dL
Standard Deviation 0.4
|
Adverse Events
BTI320 4 Grams
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
BTI320 8 Grams
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
BTI320 Matching Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BTI320 4 Grams
n=24 participants at risk
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=24 participants at risk
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 participants at risk
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
High grade osteosarcoma at left distal femur
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
Other adverse events
| Measure |
BTI320 4 Grams
n=24 participants at risk
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 8 Grams
n=24 participants at risk
three times daily, oral for 16 weeks
BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
|
BTI320 Matching Placebo
n=12 participants at risk
2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
6/24 • Number of events 8 • 16 weeks
|
16.7%
4/24 • Number of events 4 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
2/24 • Number of events 2 • 16 weeks
|
4.2%
1/24 • Number of events 4 • 16 weeks
|
16.7%
2/12 • Number of events 2 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
5/24 • Number of events 5 • 16 weeks
|
12.5%
3/24 • Number of events 6 • 16 weeks
|
16.7%
2/12 • Number of events 2 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Gastrointestinal disorders
Flatulence
|
29.2%
7/24 • Number of events 7 • 16 weeks
|
33.3%
8/24 • Number of events 8 • 16 weeks
|
16.7%
2/12 • Number of events 2 • 16 weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
16.7%
4/24 • Number of events 4 • 16 weeks
|
8.3%
2/24 • Number of events 2 • 16 weeks
|
41.7%
5/12 • Number of events 5 • 16 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
8.3%
2/24 • Number of events 2 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
1/24 • Number of events 1 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Tooth fracture
|
0.00%
0/24 • 16 weeks
|
0.00%
0/24 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
2/24 • Number of events 2 • 16 weeks
|
12.5%
3/24 • Number of events 3 • 16 weeks
|
8.3%
1/12 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place