Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01582282 · ClinicalTrials.gov registry record · Phase 4
Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects
A Phase 4 study, sponsored by Procter and Gamble.
- Terminated
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT01582282: Clinical Trial Phase 4 study, sponsored by Procter and Gamble.
NCT01582282 is a Phase 4 study that was terminated before completion, run by Procter and Gamble. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01582282, a Phase 4 study, was terminated before completion, sponsored by Procter and Gamble.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study 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
Primary Outcome
Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value
Interventions
- DIETARY_SUPPLEMENT placebo
- DIETARY_SUPPLEMENT 3.4 g psyllium BID
- DIETARY_SUPPLEMENT 6.8g psyllium BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 1988-05 |
| Est. Completion | 1990-01 |
| Phase | Phase 4 |
Why NCT01582282 stopped before completion
NCT01582282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01582282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01582282 about?
NCT01582282 is a clinical study titled "Study of Metamucil on Blood Glucose and HbA1c in Type II NIDDM Subjects". 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 ran...
What is the current status of trial NCT01582282?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 1988-05. Estimated completion is 1990-01.
What interventions are being tested in trial NCT01582282?
The interventions under investigation include: placebo (DIETARY_SUPPLEMENT), 3.4 g psyllium BID (DIETARY_SUPPLEMENT), 6.8g psyllium BID (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01582282?
This trial is sponsored by Procter and Gamble, which has 70 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01582282's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02800486 · 37 participants · Phase 2
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
- NCT03173937 · 37 participants · Phase 1
Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn(TM), Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome
- NCT03295227 · 37 participants · Phase 1
Pembrolizumab in Treating Participants With Unresectable Thymoma or Thymic Cancer
- NCT03401047 · 37 participants · Early Phase 1
Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia