NCT05579977

When you have uncontrolled type 2 diabetes despite taking medication, it may be time to look at the bigger picture. Participating in our clinical trial includes support services and weight loss assistance. Our study team makes sure you’re not alone on your journey to a healthier life.

Take the next step and see if you may qualify for a clinical trial of an oral, once-daily study drug taken with metformin to see if it may better control your blood sugar and weight.

The study drug is a pill that works differently because it may help your body produce more insulin. All participants will continue to take metformin during the study.

Card Summary Component

Who may participate

 

You may be able to participate if you:

  • Are currently taking metformin
  • Have an HbA1C level of 7 to 10 (blood sugar is not well controlled)
Condition

Type 2 Diabetes

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues such as lifespan, quality of life, and health risks.

Age

18 to 75 years

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

Get started — See if you may qualify

A first step as you consider this study is to answer a 5-minute questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.  

You will then be asked to provide your contact information for a study representative to contact you and discuss the next steps. If you’re interested, they will do a more detailed review of your medical history to see if you are able to participate. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study. 

Your answers to these initial questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you.

Card Summary Component

What to expect

 

If you qualify and decide to participate, you will receive:

  • All clinical trial-related care, study drug, diet and exercise counseling, glucometer, and other diabetes testing supplies at no charge
  • Close monitoring by a study physician of your diabetes, weight, and overall health
  • Reimbursement for any reasonable expenses that you may have as a result of taking part in the study such as parking, meals, or other travel-related expenses
  • The opportunity to help advance scientific knowledge and potentially improve the care of people with diabetes

Your safety while participating is our highest priority. If you have questions or concerns at any point, a study team member is available. Your participation is voluntary, and you are free to withdraw at any time. Your privacy will be maintained throughout the study.

Length of study treatment

Up to 44 weeks

Length of study treatment is the length of time the study participants will receive the study treatment.

Number of study visits

Up to 14 study visits Up to 8 telephone contacts

Each study’s design specifies thenumber of study visits and the total length of the trial.

Long-term follow-up

4 weeks total, including 1 site visit and 1 telephone contact

Some studies require the study team to stay in contact with the participant for a period of time after the participant completes the main part of the study. This long-term follow-up is to collect additional information on the study drug over time.

About Type 2 Diabetes

About Type 2 Diabetes

Diabetes is a condition that occurs when your blood sugar, or blood glucose levels, are too high.Glucose is your body’s main source of energy, and it comes from the food you eat.Insulin is a hormone that helps glucose move from your bloodstream into your cells to use for energy.People with Type 2 diabetes, the most common form of diabetes, either don't produce enough insulin, or their body doesn’t use insulin as well as it should.As a result, glucose builds up in the blood and causes blood sugar levels to rise.Blood sugar that is too high over a long period of time can lead to serious health problems such as heart disease, vision loss, kidney disease, or nerve damage.1,2

Additional clinical trial information

During the clinical trial you will be randomly assigned to receive either the study drug, a placebo, or another oral drug already prescribed for diabetes. All participants will continue their metformin during the study.

Frequently asked questions

Why is Pfizer conducting this diabetes clinical trial?

Pfizer is conducting this diabetes clinical trial to see if an oral, once-daily study drug may better control blood sugar and weight in people who still experience high blood sugar while taking metformin. All participants will continue their metformin during the study.

Is this page helpful?
0
0

What will happen if I take part in this study?

If you qualify and decide to participate, you will be in the study for up to 56 weeks (just over 1 year). There will be up to 15 visits to the study site and 9 telephone contacts.

There are 3 phases to this study. The Screening Period lasts up to 4 weeks and involves medical tests to see if you qualify for the study. The Study Treatment Period lasts up to 44 weeks. During this time, you will visit the clinic for health assessments and have telephone contacts with the study team. You will be randomly assigned to take either the study drug, a placebo, or another oral medication already prescribed for diabetes. In addition, you will also take metformin. The Follow-Up Period lasts 4 weeks, during which time your overall health, diabetes symptoms, and weight will be evaluated.

Is this page helpful?
0
0

How do I decide if this study is right for me?

Before you agree to participate, the study team will go over all aspects of the study with you. If you decide to participate, you will be given a document called an Informed Consent Form that provides, in writing, the study’s purpose, assessments, procedures, potential benefits and risks, and precautions. You will have the opportunity to ask any questions you have, then you can decide if participating is right for you.

Is this page helpful?
0
0

What is a placebo and is there a chance I will receive a placebo in this study?

A placebo looks like the study drug but does not contain any active drug. Yes, there is a chance that you will receive a placebo. You will be randomly assigned (by chance) to receive the study drug, a placebo, or another oral drug that is prescribed for diabetes. All participants will also receive metformin. The study team can give you more information about your chances of receiving a placebo.

Is this page helpful?
0
0

What happens to my personal information if I take part in the study?

The clinical research team will respect and protect your privacy and will not share your information except as required by law. Your personal information will be stored with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be protected.

Is this page helpful?
0
0

Can I leave the study early?

Yes, your participation is completely voluntary, so you may withdraw from the study, for any reason, and at any time. If you do decide to leave early, you will be asked to notify the study team before doing so. You will also be asked to return to the study site at least once to complete a final visit and return any unused study drug.

Is this page helpful?
0
0

Is there a cost to participate?

No. You will get the study drug and all study-related medical tests at no charge. You will be reimbursed for any reasonable expenses that you may have as a result of taking part in this study. These may include parking, meals, or other travel-related expenses. You do not need health insurance to take part.

Is this page helpful?
0
0

Do I need my doctor’s permission to participate?

No, you do not need your doctor’s permission to participate. However, either you or the study doctor, with your permission, may contact your personal physician to discuss your participation in the clinical research study before you begin and keep your physician up to date about your progress during the study.

Is this page helpful?
0
0

References:

  1. What is diabetes? National Institute of Diabetes and Digestive and Kidney Diseases. Accessed September 14, 2022. https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes
  2. What is diabetes? Centers for Disease Control and Prevention. Last reviewed July 7, 2022. Accessed September 14, 2022. https://www.cdc.gov/diabetes/basics/diabetes.html
  3. About diabetes. International Diabetes Federation. Last updated July 7, 2022. Accessed September 14, 2022. https://www.idf.org/aboutdiabetes/what-is-diabetes.html