Effects of Metformin on Low Back Pain

NCT04055012 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: STUDY19010007
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the current study is to determine the effects of metformin in non-diabetic patients with low back pain, and identify novel targets for future treatments

Conditions

Low Back Pain

Keywords

Low Back Pain; Metformin; Placebo

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Numeric Pain Rating Scale

  Scores range from 0 to 10 with a higher score indicating more severe pain

  Up to 15 months

• Change From Baseline in Oswestry Disability Index (ODI)

  Scores range from 0% to 100% with higher scores indicating greater disability

  Up to 15 months

Secondary Outcomes (12)

• Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment

  Up to 15 months

• Change From Baseline in 10 Meter Walk Test

  Up to 15 months

• Change From Baseline in Fear Avoidance Questionnaire

  Up to 15 months

• Change From Baseline in STarT Back Tool

  Up to 15 months

• Change From Baseline in 6-item Pain Catastrophizing Scale

  Up to 15 months

Study Arms (4)

High Dose Metformin

EXPERIMENTAL

High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.

Drug: Metformin

Low Dose Metformin

EXPERIMENTAL

Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo Group (n=100). Subjects will receive placebo and will be instructed to take either 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months OR take 1 placebo tab for 6 months.

Drug: Placebo

Wait-List Control

OTHER

Control Group (n=100). Subjects will be told that they are in the wait-list control group. They will have a 3 month "waiting period" before they will be randomized again to a treatment group. They will be randomized to one of the previous groups.

Drug: Metformin; Drug: Placebo

Interventions

Metformin DRUG

500mg tabs of Metformin Extended Release

Also known as: Glucophage, Glucophage Extended Release, Metformin Extended Release, Metformin ER

High Dose Metformin; Low Dose Metformin; Wait-List Control

Placebo DRUG

Placebo Tabs

Placebo; Wait-List Control

Eligibility Criteria

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

You may qualify if:

• Age 18 and above
• Diagnosed with axial low back pain (low back pain more severe than pain in other parts of the body, without radiation of pain into the lower extremities).
• Women of child bearing potential must have a negative serum pregnancy test at baseline.

You may not qualify if:

• Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatory arthropathies
• Progressive lower extremity weakness or numbness
• Recent oral steroid use (within last 3 months)
• NSAID use
• Chronic kidney disease (eGFR \<60)
• Diagnosis of diabetes mellitus
• Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
• Unable to take an oral medication in a non crushable pill form
• Taking metformin presently or within the last 6 months
• History of allergy to metformin
• History of lactic acidosis
• Severe Hepatic dysfunction
• Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
• Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
• Currently taking cimetidine

Sponsors & Collaborators

• Gwendolyn Sowa: lead

Study Sites (2)

UPMC Kaufmann Medical Building

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Wexford Spine Center

Wexford, Pennsylvania, 15090, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Metformin

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

The study was halted early due to funding redirection. Due to limited sample size, formal statistical analysis for between group comparisons was not feasible, and no clear trends were established.

Results Point of Contact

• Title: Study Coordinator
• Organization: The University of Pittsburgh

kesslerl@upmc.edu

412-692-2084

Study Officials

• Gwendolyn Sowa, MD, PhD

  The University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: January 7, 2020
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)