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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 is a Phase 4 study that was terminated before completion, run by Procter and Gamble. The registered enrollment target is 37 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01582282
The ClinicalTrials.gov registry entry for NCT01582282 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Procter and Gamble, which has 70 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01582282 reports 0 study locations.
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.
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