Trial Outcomes & Findings for Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects (NCT NCT01582282)
NCT ID: NCT01582282
Last Updated: 2012-11-15
Results Overview
Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
12 weeks
Results posted on
2012-11-15
Participant Flow
Participant milestones
| Measure |
Psyllium 3.4g BID
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
8
|
|
Overall Study
COMPLETED
|
13
|
12
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Psyllium 3.4g BID
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
fasting blood glucose outside Protocol
|
0
|
1
|
0
|
Baseline Characteristics
Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects
Baseline characteristics by cohort
| Measure |
Psyllium 3.4g BID
n=15 Participants
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=14 Participants
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 Participants
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
37 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age Continuous
|
61.8 years
STANDARD_DEVIATION 9.39 • n=93 Participants
|
64.8 years
STANDARD_DEVIATION 8.42 • n=4 Participants
|
56.5 years
STANDARD_DEVIATION 9.99 • n=27 Participants
|
61.8 years
STANDARD_DEVIATION 9.43 • n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
14 participants
n=4 Participants
|
8 participants
n=27 Participants
|
37 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-Treat
Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value
Outcome measures
| Measure |
Psyllium 3.4g BID
n=13 Participants
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=12 Participants
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 Participants
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Change From Baseline in Fasting Glucose
|
-7.73 mg/dL
Standard Error 8.02
|
-17.81 mg/dL
Standard Error 8.81
|
22.91 mg/dL
Standard Error 10.71
|
PRIMARY outcome
Timeframe: 12 weeksChange is defined as Post-Baseline minus Baseline
Outcome measures
| Measure |
Psyllium 3.4g BID
n=13 Participants
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=12 Participants
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 Participants
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Change From Baseline in Fasting HbA1c
|
-0.27 percentage of total hemoglobin
Standard Error 0.12
|
-0.39 percentage of total hemoglobin
Standard Error 0.13
|
0.26 percentage of total hemoglobin
Standard Error 0.16
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analysis of Covariance of Cholesterol Measures Intent-to-Treat
Change is defined as Post-Baseline minus Baseline
Outcome measures
| Measure |
Psyllium 3.4g BID
n=13 Participants
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=12 Participants
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 Participants
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Change From Baseline in Fasting HDL Cholesterol
|
-0.90 mg/dL
Standard Error 1.21
|
1.58 mg/dL
Standard Error 1.27
|
-0.42 mg/dL
Standard Error 1.54
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The LDL cholesterol values for two subjects at week 12 were unreportable.
Change is defined as Post-Baseline minus Baseline
Outcome measures
| Measure |
Psyllium 3.4g BID
n=11 Participants
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=12 Participants
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 Participants
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Change From Baseline in Fasting LDL Cholesterol
|
-11.51 mg/dL
Standard Error 5.86
|
-5.84 mg/dL
Standard Error 5.59
|
-5.41 mg/dL
Standard Error 6.89
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analysis of Covariance of Cholesterol Measures Intent-to-Treat
Change is defined as Post-Baseline minus Baseline
Outcome measures
| Measure |
Psyllium 3.4g BID
n=13 Participants
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=12 Participants
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 Participants
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Total Cholesterol Change From Baseline
|
-12.96 mg/dL
Standard Error 5.22
|
-4.88 mg/dL
Standard Error 5.43
|
-5.12 mg/dL
Standard Error 6.66
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analysis of Covariance of Cholesterol Measures Intent-to-Treat
Change is defined as Post-Baseline minus Baseline
Outcome measures
| Measure |
Psyllium 3.4g BID
n=13 Participants
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=12 Participants
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 Participants
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Triglyceride Change From Baseline
|
-8.95 mg/dL
Standard Error 16.22
|
-8.26 mg/dL
Standard Error 17.03
|
-1.81 mg/dL
Standard Error 20.41
|
Adverse Events
Psyllium 3.4g BID
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
6.8g Psyllium BID
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Psyllium 3.4g BID
n=15 participants at risk
Metamucil, psyllium 3.4g BID (6.8g/day)
|
6.8g Psyllium BID
n=14 participants at risk
Metamucil, psyllium 6.8g BID (13.6g/day)
|
Placebo
n=8 participants at risk
Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Abnormal faeces
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
25.0%
2/8 • Number of events 2 • through 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
26.7%
4/15 • Number of events 4 • through 12 weeks
|
28.6%
4/14 • Number of events 4 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Faecal volume increased
|
0.00%
0/15 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
5/15 • Number of events 6 • through 12 weeks
|
35.7%
5/14 • Number of events 6 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Gastrointestinal disorders
Stools abnormal
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
General disorders
Chest pain
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
General disorders
Malaise
|
0.00%
0/15 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Infections and infestations
Influenza
|
13.3%
2/15 • Number of events 2 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/15 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Investigations
Stool analysis abnormal
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/15 • through 12 weeks
|
14.3%
2/14 • Number of events 2 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/15 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
12.5%
1/8 • Number of events 1 • through 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/15 • through 12 weeks
|
7.1%
1/14 • Number of events 1 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Number of events 1 • through 12 weeks
|
0.00%
0/14 • through 12 weeks
|
0.00%
0/8 • through 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data, calculations, interpretations, opinions, and recommendations are the property of P\&GP
- Publication restrictions are in place
Restriction type: OTHER