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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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This study plans to learn more about the effect of semaglutide once weekly on intestinal permeability in individuals with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC semaglutide | Experimental | Participants receive a once weekly, subcutaneous, Semaglutide injection for 16 weeks in addition to the participants background metformin monotherapy. The participants in this arm will begin at a 0.25 mg dose during the randomization visit, at week 4 this will be escalated to a 0.5 mg dose and at week 8 it will be escalated again to a 1.0 mg dose if tolerable by the participant. If the participant cannot tolerate the 0.25 mg dose at randomization or the 0.5 mg dose at week 4 they will be withdrawn from the study. |
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| Placebo | Placebo Comparator | Participants in this arm will be given a once weekly, subcutaneous, placebo injection matching the Semaglutide experimental arm in addition to their background metformin monotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Semaglutide 1.34 mg/mL solution for injection in 1.5 mL pre-filled PDS290 pen-injector provided by Novo Nordisk. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in lactulose mannitol ratio (LMR) test as a measure of intestinal permeability between treatment groups | The ratio of lactulose to mannitol will be measured in urine collected within 6 hours after ingestion of dual sugar. This ratio predominantly reflects small intestine permeability. | Week 16 (visit 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between treatment groups in plasma LBP | Marker of intestinal permeability | Week 8 (visit 4), Week 16 (visit 6) |
| Differences between treatment groups in Serum zonulin | Marker of intestinal permeability |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: determine the effect of semaglutide as compared to placebo on intestinal microbiota in relation to changes in intestinal permeability and inflammatory markers | Microbiome study | Visit 6 (week 16) |
Inclusion Criteria:
Exclusion Criteria:
Known or suspected hypersensitivity to trial product or related products.
Female who is pregnant, breast-feeding or intends to become pregnant or is of child- bearing potential and not using a highly effective contraceptive method.
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischemic attack (TIA) within the past 60 days prior to the day of screening.
Second anti-diabetic agent use within 3 months of screening.
Chronic kidney disease defined as eGFR < 30 mL/min/1.73 m2.
C-reactive protein (hs-CRP >10.0 mg/L) to eliminate patients with acute inflammatory process at the time of screening.
Any recent infection or antibiotic use within 3 weeks
Regular use (more than a week duration) of anti-inflammatory medication (steroid or NSAIDs) within 3 months of screening.
Regular use (more than a week duration) of any digestive health supplements, such as probiotics or prebiotics within 3 months screening.
Diagnosis of chronic intestinal inflammatory disease such as Crohn's disease, ulcerative colitis or irritable bowel syndrome.
Prior bariatric or bowel surgery
Heart failure presently classified as being in New York Heart Association (NYHA) Class IV.
Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC).
History of chronic pancreatitis or history of acute pancreatitis within 6 months of screening.
Chronic consumption of > 2 alcoholic standard drinks per day as defined by:
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| Name | Affiliation | Role |
|---|---|---|
| Neda Rasouli, MD | University of Colorado, Denver | Principal Investigator |
| Joseph Onyiah, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Placebo | Drug | Semaglutide placebo, solution for injection, 1.5 mL pre-filled PDS290 pen-injector provided by Novo Nordisk. |
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| Week 8 (visit 4), Week 16 (visit 6) |
| Differences between treatment groups in Fecal Calprotectin | Marker of intestinal inflammation | Week 8 (visit 4), Week 16 (visit 6) |
| Differences between treatment groups in plasma IL-6 | Marker of chronic inflammation | Week 8 (visit 4), Week 16 (visit 6) |
| Differences between treatment groups in plasma IL-8 | Marker of chronic inflammation | Week 8 (visit 4), Week 16 (visit 6) |
| Differences between treatment groups in plasma TNFα | Marker of chronic inflammation | Week 8 (visit 4), Week 16 (visit 6) |
| Differences between treatment groups in plasma hs-CRP | Marker of chronic inflammation | Week 8 (visit 4), Week 16 (visit 6) |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |