Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients

NCT05515978 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 19-1536NCI-2021-05911
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

Metformin is used widely in the treatment of type 2 diabetes. It has off-label indications for use in the prevention of diabetes and in hyperinsulinar obesity. In medical practices, the implementation of metformin for these off-label indications is variable, often at the level of the provider. Multiple retrospective investigations have also shown a clinical benefit in men with prostate cancer who are incidentally treated with metformin. This pragmatic study will test the feasibility of enrolling patients who have glucose intolerance (as defined by HbA1c of 5.7-6.4%) and/or who have increased BMI (BMI greater than or equal to 25 kg/m2) to a randomized pragmatic study of metformin plus lifestyle modification information versus lifestyle modification information only. For purposes of the scope of this project and the study's feasibility, this will be implemented in a group of prostate cancer patients, who may have additional benefits from metformin.

Conditions

Prostate Cancer

Keywords

Pragmatic; Prostate; Cancer; Prostate Cancer; Metformin; Lifestyle; Lifestyle changes; Lifestyle Modifications

Outcome Measures

Primary Outcomes (1)

• Successful accrual of 100 patients to the pragmatic trial in the first four years

  Once there are 6 months of follow-up data on the first 100 patients, a formal analysis will be done to determine the completeness of data and the potential for a powered study. Outcome measure was amended January 2025.

  4 years

Secondary Outcomes (26)

• Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Body Mass Index

  2 years

• Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Weight

  2 years

• Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on HbA1C

  2 years

• Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Blood Pressure

  2 years

• Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Glucose Levels

  2 years

Study Arms (2)

Metformin and Lifestyle Modification Arm

ACTIVE COMPARATOR

For the metformin arm: metformin will be obtained as a standard of care medication from the patient's general pharmacy. This will be given for a clinical indication (e.g. prediabetes or overweight/obese). It will not be supplied by the study, but billed to Medicare, self pay or 3rd party payer. Lifestyle modification and prediabetes information will be provided via MHC or other electronic means on a quarterly basis.

Drug: Metformin; Behavioral: Lifestyle Modification

Lifestyle Modification Only Arm

PLACEBO COMPARATOR

Patients randomized to this arm will receive standard lifestyle modification recommendations. This will include the general recommendation to increase exercise level mildly, after discussing with the medical provider. There is a potential low-level risk in increasing one's exercise levels.

Behavioral: Lifestyle Modification

Interventions

Metformin DRUG

Metformin is a medication used to treat type 2 diabetes, gestational diabetes, and prediabetes. In this study, patients on the Metformin arm will be started on 850 mg daily for 2 weeks, then escalated to a final dose of 850 mg twice daily, which is lower than the maximum recommended dose of 2550 mg total daily.

Also known as: Glucophage, Riomet, Glumetza

Metformin and Lifestyle Modification Arm

Lifestyle Modification BEHAVIORAL

Patients randomized to this arm will receive standard lifestyle modification recommendations. This will include the general recommendation to increase exercise level mildly, after discussing with the medical provider. There is a potential low-level risk in increasing one's exercise levels. Here are some examples of the educational material from the American Diabetes Association website, and topics will be rotated on quarterly basis: Healthy eating: https://www.diabetes.org/nutrition/healthy-food-choices-made-easy Prediabetes: https://www.diabetes.org/diabetes-risk/prediabetes Fitness: https://www.diabetes.org/fitness/get-and-stay-fit Weight loss: https://www.diabetes.org/fitness/weight-loss

Lifestyle Modification Only Arm; Metformin and Lifestyle Modification Arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria. The patients will be screening for eligibility and offered an electronic consent via the Epic medical record and the patient portal (My Health Connection - MHC) or otherwise through Epic:
• Provision to sign and date the consent form in MHC or otherwise via Epic.
• Subjects must have an MHC Account to participate in the study
• Be a male aged ≥18 years of age on day of signing the informed consent.
• Impaired glucose tolerance and/or overweight, and appropriate to receive metformin, meeting at least one of the following in the last year (timing relative to the consent presentation not start of therapy):
• HbA1c of 5.7 - 6.4 %
• BMI≥25 kg/m\^2
• Have a prostate cancer diagnosis
• Have a clinical relationship with a participating provider at a UCHealth facility.

You may not qualify if:

• On therapy for diabetes including any of the following alone or in combination medications (diet controlled or managed diabetes is allowed - e.g.
• diagnosis of Diabetes, but without an active prescription for anti-glycemic medication):
• Metformin
• Insulin
• Glipizide
• Glyburide
• Glimepiride
• Pioglitazone
• Rosiglitazone
• Sitagliptin
• Saxagliptin
• Linagliptin
• Alogliptin
• Canagliflozin
• Dapagliflozin

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (4)

Colorado Research Center

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth-Southern Colorado

Colorado Springs, Colorado, 80863, United States

RECRUITING

UCHealth-Metro Denver

Denver, Colorado, 80217-3364, United States

RECRUITING

UCHealth-Northern Colorado

Fort Collins, Colorado, 80521, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Thomas Flaig, MD

  Colorado Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Buchanan

CONTACT

303-724-5912; emily.buchanan@cuanschutz.edu

Marjorie McIntyre

CONTACT

303-724-5868; marjorie.mcintyre@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this pragmatic trial, a 2-step electronic consent approach to enroll patients in the metformin + lifestyle modification or lifestyle modification arms will be used. The initial consent will invite patients to join a cohort to study prostate cancer and it will describe the general pragmatic framework under which this protocol will take place with the opportunity for additional trial opportunities. Subsequent consents will be limited to those who consented to the initial project and are found to be eligible for a specific trial (e.g. this metformin/lifestyle intervention trial). Within the framework of this pragmatic trial and electronic self-consent, these subsequent consents will be more focused and limited to the specific involvement in the arm in which they have been randomized. This general approach will follow the trials within cohorts paradigm.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: August 25, 2022
• Study Start: October 10, 2022
• Primary Completion (Estimated): October 20, 2035
• Study Completion (Estimated): November 6, 2036
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)