Non-Insulin-dependent Diabetes MellitusPhase 4NCT01582282
Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects
A Phase 4 study testing 3.4 g psyllium BID and 6.8g psyllium BID in people with Non-Insulin-dependent Diabetes Mellitus, run by Procter and Gamble at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 80 years
- Conditions the study is for
- Non-Insulin-dependent Diabetes Mellitus
- What is being tested?
- 3.4 g psyllium BID and 6.8g psyllium BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- May 1988to Jan 1990
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have a condition that would interfere with evaluation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami, Diabetes Unit D-1
Miami, Florida, 33136
International Diabetes Center
Minneapolis, Minnesota, 55416
About this study
Official title: A Clinical Study to Determine the Ability of Metamucil to Reduce Fasting Blood Glucose and HbA1c Levels in Type II NIDDM
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
Read the 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.
- Conditions
- Non-Insulin-dependent Diabetes Mellitus
- Being tested
- placebo, 3.4 g psyllium BID, 6.8g psyllium BID
- Keywords
- Type II NIDDM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
fiber-free placebo
3.4 g psyllium BIDDietary supplement
Also called Metamucil
3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil)
6.8g psyllium BIDDietary supplement
Also called Metamucil
6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | matched placebo BID Receives: Dietary Supplement: placebo |
| psyllium 3.4g BID | Active comparator | 3.4g psyllium BID for a Total of 6.8g daily Receives: Dietary Supplement: 3.4 g psyllium BID |
| 6.8g psyllium BID | Active comparator | 6.8g psyllium BID for a total of 13.6 g/day Receives: Dietary Supplement: 6.8g psyllium BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fasting Glucose
Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value
Measured: 12 weeks
Change From Baseline in Fasting HbA1c
Change is defined as Post-Baseline minus Baseline
Measured: 12 weeks
Change From Baseline in Fasting HDL Cholesterol
Change is defined as Post-Baseline minus Baseline
Measured: 12 weeks
Change From Baseline in Fasting LDL Cholesterol
Change is defined as Post-Baseline minus Baseline
Measured: 12 weeks
Total Cholesterol Change From Baseline
Change is defined as Post-Baseline minus Baseline
Measured: 12 weeks
Triglyceride Change From Baseline
Change is defined as Post-Baseline minus Baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startMay 1988
- Primary completionJan 1990
- Study completionJan 1990
Why it stopped: due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Insulin-dependent Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Reeves, MD, Principal investigator, University of MiamiRichard Bergenstal, MD, Principal investigator, International Diabetes Center, Minneapolis, MN 55416
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582282
- Sponsor's protocol ID
- LX-105
- Status last verified
- Nov 2012
- First submitted
- 18 Apr 2012
- Last updated
- 15 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Determine the Ability of Metamucil to Reduce Fasting Blood Glucose and HbA1c Levels in Type II NIDDM
- ClinicalTrials.gov ID
- NCT01582282
- Acronym / sponsor ID
- LX-105
- Conditions
- Non-Insulin-dependent Diabetes Mellitus
- Keywords
- Type II NIDDM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow enrollment
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- May 1988
- Primary completion
- Jan 1990 (actual)
- Study completion
- Jan 1990 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 2 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placebomatched placebo BID |
| psyllium 3.4g BID | Active comparator | Dietary Supplement: 3.4 g psyllium BID3.4g psyllium BID for a Total of 6.8g daily |
| 6.8g psyllium BID | Active comparator | Dietary Supplement: 6.8g psyllium BID6.8g psyllium BID for a total of 13.6 g/day |
Who may qualify
- Ages
- 36 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Have a condition that would interfere with evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebofiber-free placebo | Dietary supplement | placebo |
| 3.4 g psyllium BIDAlso: Metamucil3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil) | Dietary supplement | psyllium 3.4g BID |
| 6.8g psyllium BIDAlso: Metamucil6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil) | Dietary supplement | 6.8g psyllium BID |
Primary outcome
Change From Baseline in Fasting Glucose
Time frame: 12 weeks
Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value
Change From Baseline in Fasting HbA1c
Time frame: 12 weeks
Change is defined as Post-Baseline minus Baseline
Change From Baseline in Fasting HDL Cholesterol
Time frame: 12 weeks
Change is defined as Post-Baseline minus Baseline
Change From Baseline in Fasting LDL Cholesterol
Time frame: 12 weeks
Change is defined as Post-Baseline minus Baseline
Total Cholesterol Change From Baseline
Time frame: 12 weeks
Change is defined as Post-Baseline minus Baseline
Triglyceride Change From Baseline
Time frame: 12 weeks
Change is defined as Post-Baseline minus Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Reeves, MD principal investigator
University of Miami
Richard Bergenstal, MD principal investigator
International Diabetes Center, Minneapolis, MN 55416
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3.4 g psyllium BID and 6.8g psyllium BID in people with Non-Insulin-dependent Diabetes Mellitus, run by Procter and Gamble at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Fasting Glucose (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2012.