Insulin SensitivityPhase 2/3NCT03452267
Insulin Signaling in Skeletal Muscle
A Phase 2/3 study testing Metformin and Pioglitazone in people with Insulin Sensitivity, run by Wayne State University.
Trial summary
The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Insulin Sensitivity
- What is being tested?
- Metformin and Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL
- General Inclusion Criteria:
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
- Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.
Who cannot join
- Oral glucose tolerance test <140 or >200mg/dL
- Treated with any of the following medications:
- Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening
- Start or change of hormonal replacement therapy within 3 months prior to screening
- Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening
- History or presence of any of the following conditions:
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- Clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG)
- Peripheral vascular disease (history of claudication)
- Clinically significant pulmonary disease.
- Current uncontrolled hypertension (systolic BP>160 mmHg, diastolic BP>100 mmHg)
- History or presence of malignancy other than basal cell or squamous cell skin cancer
- Autonomic neuropathy
- Clinically significant hematologic disease
- Any of the following abnormal laboratory values:
- Hematocrit < 35 vol%
- Serum creatinine > 1.6 mg/dl
- AST, ALT or Alkaline phosphatase > 2.5 times the upper limit of normal
- PT, PTT outside the normal reference range
- TSH outside the normal reference range
- Triglycerides > 400 mg/dl
- Platelet count < 50,000
- Current or history of drug abuse or alcohol abuse
- Blood donation within 2 months prior to screening
- Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.
- Diagnosed with Type 1 diabetes
About this study
Official title: Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle
The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.
- Conditions
- Insulin Sensitivity
- Being tested
- Metformin, Pioglitazone, Placebo
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
oral, 850 mg twice daily
PioglitazoneDrug
oral, 45 mg daily
PlaceboDrug
oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin |
| Pioglitazone | Experimental | Not described Receives: Drug: Pioglitazone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic
Changes in global protein abundance levels
Measured: 3 months
Proteomic 2
Changes in global protein phosphorylation levels
Measured: 3 months
Secondary outcomes (1)
Epigenomic
Change in global DNA percent methylation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Sep 2019 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Jon Burghardt, Pharm.D., Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452267
- Sponsor's protocol ID
- MetPioMuscle
- Status last verified
- Oct 2020
- First submitted
- 12 Feb 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle
- ClinicalTrials.gov ID
- NCT03452267
- Acronym / sponsor ID
- MetPioMuscle
- Conditions
- Insulin Sensitivity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin |
| Pioglitazone | Experimental | Drug: Pioglitazone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
- Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.
Key exclusion criteria (25 listed)
- Oral glucose tolerance test <140 or >200mg/dL
- Treated with any of the following medications:
- History or presence of any of the following conditions:
- Any of the following abnormal laboratory values:
- Current or history of drug abuse or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metforminoral, 850 mg twice daily | Drug | Metformin |
| Pioglitazoneoral, 45 mg daily | Drug | Pioglitazone |
| Placebooral, once daily | Drug | Placebo |
Primary outcome
Proteomic
Time frame: 3 months
Changes in global protein abundance levels
Proteomic 2
Time frame: 3 months
Changes in global protein phosphorylation levels
1 secondary outcome
Epigenomic
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Metformin and Pioglitazone in people with Insulin Sensitivity, run by Wayne State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.