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Type 2 Diabetes Mellitus (T2DM)Phase 4NCT02285985

Effects of Saxagliptin on Adipose Tissue Inflammation in Humans

A Phase 4 study testing Saxagliptin in people with Type 2 Diabetes Mellitus (T2DM), run by Phoenix VA Health Care System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this research study, Investigators will be comparing the effects of a medication Saxagliptin versus placebo (a similar looking pill that contains no medication) on inflammation in the body. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Saxagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
1 siteUnited States
Study dates
Feb 2013to 12 Oct 2019
Phase
Phase 4
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 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Written Informed Consent
  • Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel.
  • Subjects must be able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
  • Target Population
  • Body mass index 27.5-37.5 kg/m2
  • Stable body weight (not varying >10% during the last 6 months)
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  • Age and Reproductive Status
  • Men and women, ages 21 to 70 years.
  • Women must be sterilized by hysterectomy or postmenopausal or on acceptable birth control if of childbearing potential.
  • Women of childbearing potential (WOCBP) include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
  • Amenorrhea ≥12 consecutive months without another cause and a documented serum follicle stimulating hormone (FSH) level >35 mIU/mL, or
  • Women with irregular menstrual periods and a documented serum FSH level >35 mIU/mL, or NOTE: FSH level testing is not required for women ≥62 years old with amenorrhea of ≥1 year
  • Women on hormone replacement therapy (HRT) Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential.

Who cannot join

  • Sex and Reproductive Status
  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
  • Women who are pregnant or breastfeeding
  • Target Disease Exceptions
  • Gastrointestinal disease (including gastrectomy, chronic pancreatitis, bariatric surgery and gastroparesis)
  • Hepatic disease (ALT, AST >2.5 times the upper limit of normal, high sensitivity CRP ≥1 mg/L)
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  • Kidney disease (serum creatinine >1.6 mg/dl, Creatinine Clearance 50 mL/min)
  • Hypertension (blood pressure > 150/95 mmHg) at Screening for the mean of three consecutive readings performed in a sitting position after a 5-minute resting period. If treatment for hypertension has recently been initiated, subjects must be clinically stable for 4 weeks prior to Screening
  • Cardiac disease (myocardial infarction within past year, clinically significant arrhythmia, unstable angina, congestive heart failure, or coronary artery bypass surgery within 1 year or expected to require coronary bypass surgery within 12 months of study entry).
  • Medical History and Concurrent Diseases
  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus
  • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • Malignancy other than basal cell or squamous cell skin cancer
  • Significant clinical allergic rhinitis or asthma, regularly requiring inhaled corticosteroids and/or antihistamines
  • Additional Laboratory Test Findings
  • Hemoglobin <12 g/dl in men, <11 g/dl in women
  • Abnormal prothrombin or partial thromboplastin time
  • Clinically abnormal thyroid stimulating hormone (TSH)
  • 2 hour glucose > 170mg/dl in standard oral glucose tolerance test (OGTT)
  • Allergies and Adverse Drug Reactions
  • Subjects with a history of a serious hypersensitivity reaction to saxagliptin, such as anaphylaxis, angioedema,or exfoliative skin conditions.
  • Prohibited Treatments and/or Therapies
  • Treatment with strong systemic cytochrome P450 3A4/5 (CYP 3A4/5) inhibitors
  • Treatment with any of the following medications during screening or their expected use during the study: recent systemic glucocorticoids (for more than 2 weeks), any anti-hyperglycemic agents, antineoplastic agents, transplant medications, drugs for weight loss, niacin, fibrates, or anti-retroviral medications
  • Treatment with beta-blockers, antihistamines or inhaled corticosteroids within 3 months prior to screening
  • Start or change of hormonal replacement therapy within 3 months prior to screening
  • Other Exclusion Criteria
  • Prisoners, or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
  • Currently abusing alcohol or drugs, or have a history of alcohol or drug abuse that in the investigator's opinion could cause the subject to be non-compliant; or have a general history of non-compliance with medications
  • Any acute febrile illness within 2 weeks of screening with a temperature 100°F

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Carl T. Hayden VA Medical Hospital

    Phoenix, Arizona, 85012

Other trials in United States

About this study

In this research study, Investigators will be comparing the effects of a medication Saxagliptin versus placebo (a similar looking pill that contains no medication) on inflammation in the body.

Research Hypothesis DPP-4 inhibition by saxagliptin (ONGLYZA™) reduces adipose tissue inflammation in obese individuals and this is characterized by decreases in a) reactive oxygen species (ROS) production, b) toll-like receptors (TLR) and NF-kappa B pathway activation, c) expression of pro-inflammatory genes, d) macrophage infiltration, and e) secretion of pro-inflammatory factors.

Read the detailed description

This is a randomized, prospective, double-blind study. Randomization to Saxagliptin and placebo will be in a 2:1 fashion. Treatment duration will be approximately 6 weeks.

Being tested
Saxagliptin, Placebo
Keywords
Adipose tissue, Inflammation, .Obesity
Medical subject headings
Diabetes Mellitus, Type 2, Inflammation, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SaxagliptinDrug

    Also called ONGLYZA™, Inhibitor

    Tablets: 5 mg

  • PlaceboDrug

    Also called Sugar pill

    Tablets: 5mg

Study groups in NCT02285985
Study groupRoleWhat they receive
SaxagliptinExperimentalSaxagliptin (trade-name ONGLYZA™) is used along with diet and exercise to lower blood sugar levels in patients with Type II diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Saxagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amount of insulin produced by the body after meals when blood sugar is high As the blood sugar returns towards normal, the medication effect on insulin is decreased.
Receives: Drug: Saxagliptin
PlaceboPlacebo comparatorSugar pill
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the secretion of cytokines/adipokines by adipose tissue

    The primary objective is to determine whether 6 weeks of treatment with saxagliptin, compared to placebo, causes a reduction from baseline in the production and secretion of cytokines/adipokines by adipose tissue

    Measured: 6 weeks

Secondary outcomes (3)

  1. reduction from baseline in tissue measures of inflammation

    The secondary objective is to determine whether 6 weeks of treatment with saxagliptin, compared to placebo, causes a reduction from baseline in reactive oxygen production, pro-inflammatory gene expression, toll-like receptor and nuclear factor-kappa B activation, and macrophage infiltration in adipose tissue of obese individuals

    Measured: 6 weeks

  2. change in plasma postprandial lipids

    We will also compare the change in postprandial lipids following a standard meal between placebo and saxagliptin

    Measured: 6 weeks

  3. change in reactive hyperemic index

    We will use peripheral artery tonometry to measure the change in endothelial function by measuring reactive hyperemic index

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2014 (estimated)
  2. Study startFeb 2013
  3. Primary completion12 Oct 2019
  4. Study completion12 Oct 2019

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285985
Sponsor's protocol ID
032
Other IDs
0086
Status last verified
Jul 2024
First submitted
17 Jun 2014
Last updated
22 Jul 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Subject to VA regulation.

Publications

  • Kim SH, Liu A, Ariel D, Abbasi F, Lamendola C, Grove K, Tomasso V, Ochoa H, Reaven G. Effect of salsalate on insulin action, secretion, and clearance in nondiabetic, insulin-resistant individuals: a randomized, placebo-controlled study. Diabetes Care. 2014 Jul;37(7):1944-50. doi: 10.2337/dc13-2977.

    PubMed 24963111

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin in people with Type 2 Diabetes Mellitus (T2DM), run by Phoenix VA Health Care System at 1 site in United States.

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 13 inclusion and 32 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: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in the secretion of cytokines/adipokines by adipose tissue (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02285985, which also lists 1 linked publication.

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 22 Jul 2024.

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