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Diabetes drug metformin tested as possible CLL treatment

NCT ID NCT01750567

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This phase 2 pilot study tested the diabetes drug metformin in 37 people with chronic lymphocytic leukemia (CLL) that had come back after treatment, or in untreated CLL with a specific genetic change (11q deletion). The goal was to see if metformin could slow the cancer's growth. Metformin is cheap and generally safe, but this was a small, early study, so results are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin (Glucophage), a diabetes drug
What this could lead to
If it works, this could point toward a new, inexpensive, and well-tolerated treatment option for certain types of chronic lymphocytic leukemia.
What could go wrong
This is a small, early-phase pilot study with only 37 participants. Metformin is not a standard cancer treatment, and it may not slow the disease or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

37 people

The number who actually took part.

Started

Nov 2012

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients should have a confirmed diagnosis of chronic lymphocytic leukemia defined as all of the following: * ALC \> 5000 * Positive for either CD19 or CD 20 together with CD23 and CD5. * Less than 55% atypical cells 2. Patients who relapse after receiving a one or more courses of fludarabine, bendamustine, cytoxan, rituxan, chlorambucil, or campath based therapy. 3. Patients should have findings of relapse by one or both of the following: * ALC \> 5000 on 2 consecutive occasions and increasing * Any increase in lymphadenopathy over best response that has persisted for more than 3 months 4. Patient with confirmed del11q mutation may be included if untreated. 5. Age \> or equal to 18 years old and \< 80 years of age during the course of therapy 6. ECOG performance 0-2 7. Life expectancy \> 12 months 8. Patients must have normal organ function as defined as below: * AST and ALT \< 2 times the upper limit of normal * alkaline phosphatase \< 2 ULN * serum conjugated bilirubin \< 1.5 ULN (exception of Gilbert disease) * serum creatinine less than or equal to 1.5 in males, or 1.4 in females * GFR \> 59 9. Ability to understand and the willingness to sign a written informed consent document 10. Patient must be able to drink and eat more than 75% of their usual daily meals. Exclusion Criteria: 1. Patients with active CLL disease requiring urgent chemotherapy 2. Patients may not be receiving any other investigational agents. 3. Patients less than 30 days from last treatment for CLL. 4. History of allergic reactions attributed to metformin or other biguanides. 5. Known diabetes (type 1 or 2), fasting glucose \> or equal to 7.0 mmol/L (126 mg/dL), or HgbA1C \> 6.5 6. Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason 7. Current or planned pregnancy or lactation in women of child bearing age (confirmed by negative pregnancy test prior to start of therapy). 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and sepsis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 9. Conditions which would increase risk of lactic acidosis including: * Known alcoholism or ingestion of more than 3 alcoholic beverages per day * History of congestive heart failure defined as NYHA class III or IV * History of metabolic acidosis * Ongoing or active infection concerning for sepsis or SIRS

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.