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NCT01750567 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL) and Untreated CLL
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT01750567: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT01750567 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01750567, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated medication. More recently metformin has been shown to act against carcinomas by two mechanisms: 1) an indirect, insulin-dependent mechanism which sensitizes tissues to insulin, inhibits hepatic gluconeogenesis, and stimulates uptake of glucose in muscle, thereby reducing fasting blood glucose and circulating levels of insulin, lowering the pro survival activity of the insulin/INSR axis, and 2) a direct, insulin-independent mechanism which activates the AMP-activated protein kinase (AMPK) pathway and leads to inhibition of the mTOR pathway. Given the investigators preliminary published data on insulin and mTOR inhibition\[1\] metformin is an attractive candidate for a pilot clinical trial in CLL patients.
Primary Outcome
While patients are on metformin therapy, time to treatment failure will be defined as one or all of the following criteria: 1. ALC \> 5000 on 3 occasions after start of metformin treatment and increasing by 25% or more on each occasion, which will be measured every 3 months. 2. An increase of Rai Stage (0-3) by one stage. 3. An increase in any lymph node by \>50% as assessed by either physical exam (all patients) or CT scanning (only if ordered as part of routine clinical management). 4. Worsen
Interventions
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2012-11 |
| Est. Completion | 2025-02-28 |
| Phase | Phase 2 |
What the finished NCT01750567 record still lists
NCT01750567 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Metformin is the first listed.
NCT01750567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01750567 about?
NCT01750567 is a clinical study titled "A Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL) and Untreated CLL". Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated medication. More recently metformin has been shown to act against carcinomas by two mechanisms: 1) an indirect, insulin-dependent mechanism which sensitizes tissues to insulin, inhibits hepatic gluconeogenesis, an...
What is the current status of trial NCT01750567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2012-11. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT01750567?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT01750567?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01750567's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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