Non-Insulin-dependent Diabetes Mellitus
Conditions
Keywords
Type II NIDDM
Brief summary
A double-blind, randomized, placebo-controlled, multi-dose clinical study consisting of 2 phases; 1) an 8-week lead-in period during which patients followed a diet judged to be within the acceptable guidelines of the ADA, and 2) a 12-week treatment period, at the beginning of which, Subjects are randomly assigned to 1 of the 3 treatment groups: placebo, 3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil) or 6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil). For 12 weeks, Subjects took Metamucil or the fiber-free placebo BID, just prior to breakfast and dinner. Patients visited the clinic 10 times during the 20-week period at Screening, Weeks -8, -6, -4, 0, Day 3, and Weeks 2, 4, 8 and 12, fasting at least 12 hours prior to each visit where a blood sample was taken (all visits except Week -6 and Day 3) for analysis of fasting serum glucose and lipid levels, and HbA1c. Clinical chemistry, hematology and urinalysis were done at Weeks -8, 0 and 12. The completed 7-day food diaries were reviewed by the study dietician at each visit and discussed with the patient to ensure compliance with the recommended diet and the patients' body weights were recorded
Detailed description
During the first phase, lead-in period during Subjects followed a diet judged to be within the acceptable guidelines of the ADA, with compliance assessed by a study dietician using 7-day food diaries completed by the patients. Subject body weight, serum glucose and serum HbA1c, and lipid levels were allowed to stabilize during this period. During the 12-week treatment period, Subjects were stratified by either diet alone or diet and oral hypoglycemic medication and randomly assigned to 1 of the 3 treatment groups: placebo, 3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil) or 6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil). For 12 weeks, patients took Metamucil or the fiber-free placebo BID, just prior to breakfast and dinner. Patients visited the clinic 10 times during the 20-week period at Screening, Weeks -8, -6, -4, 0, Day 3, and Weeks 2, 4, 8 and 12, fasting at least 12 hours prior to each visit where a blood sample was taken (all visits except Week -6 and Day 3) for analysis of fasting serum glucose and lipid levels, and HbA1c. Clinical chemistry, hematology and urinalysis were done at Weeks -8, 0 and 12. The completed 7-day food diaries were reviewed by the study dietician at each visit and discussed with the patient to ensure compliance with the recommended diet and the patients' body weights were recorded.
Interventions
DIETARY_SUPPLEMENT3.4 g psyllium BID
3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil)
DIETARY_SUPPLEMENTplacebo
fiber-free placebo
DIETARY_SUPPLEMENT6.8g psyllium BID
6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil)
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
36 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Have a clinical diagnosis of Type II diabetes mellitus, controlled by diet and/or second generation oral hypoglycemic drugs, with the onset of the disease after age 35. * Are between 0 and 50% above normal body weight (adjusted by frame) according to the Metropolitan Life Insurance Tables. * Are male or female, aged 36-80 years with a diagnosis made at least 1 year prior to enrollment. * Have an HbA1c level between 6 and 10% * Have a fasting serum glucose level between 120-220 mg/dL and not vary by more than ±20% during the month prior to entering the treatment phase and HbA1c levels not vary by more than ±10% during the month prior to entering the treatment phase. Serum glucose level must have been between 120-220mg/dl and the subject's HbA1c between 6 and 10% at Week 0. * Have been on a stable diet consistent with ADA-recommended dietary guidelines with intake of total dietary fiber \< 15g/1000 calories and were willing to maintain this diet during the 20-week study. * Have maintained a constant body weight (±5%) during the month prior to entering the treatment phase
Exclusion criteria
* Have a condition that would interfere with evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Glucose | 12 weeks | Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value |
| Change From Baseline in Fasting HbA1c | 12 weeks | Change is defined as Post-Baseline minus Baseline |
| Change From Baseline in Fasting HDL Cholesterol | 12 weeks | Change is defined as Post-Baseline minus Baseline |
| Change From Baseline in Fasting LDL Cholesterol | 12 weeks | Change is defined as Post-Baseline minus Baseline |
| Total Cholesterol Change From Baseline | 12 weeks | Change is defined as Post-Baseline minus Baseline |
| Triglyceride Change From Baseline | 12 weeks | Change is defined as Post-Baseline minus Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psyllium 3.4g BID Metamucil, psyllium 3.4g BID (6.8g/day) | 15 |
| 6.8g Psyllium BID Metamucil, psyllium 6.8g BID (13.6g/day) | 14 |
| Placebo Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID | 8 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | fasting blood glucose outside Protocol | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 6.8g Psyllium BID | Placebo | Psyllium 3.4g BID | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 8 Participants | 15 Participants | 37 Participants |
| Age Continuous | 64.8 years STANDARD_DEVIATION 8.42 | 56.5 years STANDARD_DEVIATION 9.99 | 61.8 years STANDARD_DEVIATION 9.39 | 61.8 years STANDARD_DEVIATION 9.43 |
| Region of Enrollment United States | 14 participants | 8 participants | 15 participants | 37 participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 15 | 12 / 14 | 7 / 8 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 | 0 / 8 |
Outcome results
Primary
Change From Baseline in Fasting Glucose
Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value
Time frame: 12 weeks
Population: Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psyllium 3.4g BID | Change From Baseline in Fasting Glucose | -7.73 mg/dL | Standard Error 8.02 |
| 6.8g Psyllium BID | Change From Baseline in Fasting Glucose | -17.81 mg/dL | Standard Error 8.81 |
| Placebo | Change From Baseline in Fasting Glucose | 22.91 mg/dL | Standard Error 10.71 |
p-value: 0.028ANCOVA
p-value: 0.009ANCOVA
Primary
Change From Baseline in Fasting HbA1c
Change is defined as Post-Baseline minus Baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psyllium 3.4g BID | Change From Baseline in Fasting HbA1c | -0.27 percentage of total hemoglobin | Standard Error 0.12 |
| 6.8g Psyllium BID | Change From Baseline in Fasting HbA1c | -0.39 percentage of total hemoglobin | Standard Error 0.13 |
| Placebo | Change From Baseline in Fasting HbA1c | 0.26 percentage of total hemoglobin | Standard Error 0.16 |
p-value: 0.013ANCOVA
p-value: 0.003ANCOVA
Primary
Change From Baseline in Fasting HDL Cholesterol
Change is defined as Post-Baseline minus Baseline
Time frame: 12 weeks
Population: Analysis of Covariance of Cholesterol Measures Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psyllium 3.4g BID | Change From Baseline in Fasting HDL Cholesterol | -0.90 mg/dL | Standard Error 1.21 |
| 6.8g Psyllium BID | Change From Baseline in Fasting HDL Cholesterol | 1.58 mg/dL | Standard Error 1.27 |
| Placebo | Change From Baseline in Fasting HDL Cholesterol | -0.42 mg/dL | Standard Error 1.54 |
p-value: 0.808ANCOVA
p-value: 0.328ANCOVA
Primary
Change From Baseline in Fasting LDL Cholesterol
Change is defined as Post-Baseline minus Baseline
Time frame: 12 weeks
Population: The LDL cholesterol values for two subjects at week 12 were unreportable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psyllium 3.4g BID | Change From Baseline in Fasting LDL Cholesterol | -11.51 mg/dL | Standard Error 5.86 |
| 6.8g Psyllium BID | Change From Baseline in Fasting LDL Cholesterol | -5.84 mg/dL | Standard Error 5.59 |
| Placebo | Change From Baseline in Fasting LDL Cholesterol | -5.41 mg/dL | Standard Error 6.89 |
p-value: 0.508ANCOVA
p-value: 0.962ANCOVA
Primary
Total Cholesterol Change From Baseline
Change is defined as Post-Baseline minus Baseline
Time frame: 12 weeks
Population: Analysis of Covariance of Cholesterol Measures Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psyllium 3.4g BID | Total Cholesterol Change From Baseline | -12.96 mg/dL | Standard Error 5.22 |
| 6.8g Psyllium BID | Total Cholesterol Change From Baseline | -4.88 mg/dL | Standard Error 5.43 |
| Placebo | Total Cholesterol Change From Baseline | -5.12 mg/dL | Standard Error 6.66 |
p-value: 0.363ANCOVA
p-value: 0.978ANCOVA
Primary
Triglyceride Change From Baseline
Change is defined as Post-Baseline minus Baseline
Time frame: 12 weeks
Population: Analysis of Covariance of Cholesterol Measures Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psyllium 3.4g BID | Triglyceride Change From Baseline | -8.95 mg/dL | Standard Error 16.22 |
| 6.8g Psyllium BID | Triglyceride Change From Baseline | -8.26 mg/dL | Standard Error 17.03 |
| Placebo | Triglyceride Change From Baseline | -1.81 mg/dL | Standard Error 20.41 |
p-value: 0.785ANCOVA
p-value: 0.811ANCOVA