Oral semaglutide for Diabetes Mellitus, Type 2

Phase-Based Estimates
1
Effectiveness
1
Safety
Novo Nordisk Investigational Site, San Antonio, TX
Diabetes Mellitus, Type 2
Oral semaglutide - Drug
Eligibility
18+
Female
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Oral semaglutide will improve 2 primary outcomes and 63 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of From 0 to 24 hours after the 10th dosing (day 10).

Day 10
Area under the SNAC metabolite E1245 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,milk)
Area under the SNAC metabolite E1245 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,plasma)
Area under the SNAC metabolite E1246 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,milk)
Area under the SNAC metabolite E1246 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,plasma)
Area under the SNAC metabolite E1247 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,milk)
Area under the SNAC metabolite E1247 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,plasma)
Area under the SNAC metabolite E494 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,milk)
Area under the SNAC metabolite E494 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,plasma)
Area under the SNAC metabolite E506 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,milk)
Area under the SNAC metabolite E506 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,plasma)
Area under the SNAC plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,plasma)
Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk)
Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)
Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,plasma)
Average SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cavg,E1245,D10,milk)
Average SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cavg,E1246,D10,milk)
Average SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cavg,E1247,D10,milk)
Average SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cavg,E494,D10,milk)
Average SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cavg,E506,D10,milk)
Average SNAC milk concentration during a dosing interval after the 10th dosing (Cavg,SNAC,D10,milk)
Average semaglutide milk concentration during a dosing interval after the 10th dosing (Cavg,sema,D10,milk)
Estimated daily infant SNAC dose
Estimated daily infant SNAC metabolite E1245 dose
Estimated daily infant SNAC metabolite E1246 dose
Estimated daily infant SNAC metabolite E1247 dose
Estimated daily infant SNAC metabolite E494 dose
Estimated daily infant SNAC metabolite E506 dose
Estimated daily infant semaglutide dose
Maximum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,milk)
Maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,plasma)
Maximum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,milk)
Maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,plasma)
Maximum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,milk)
Maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,plasma)
Maximum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,milk)
Maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,plasma)
Maximum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,milk)
Maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,plasma)
Maximum SNAC milk concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,milk)
Maximum SNAC plasma concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,plasma)
Maximum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,milk)
Maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,plasma)
Minimum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmin,E1245,D10,milk)
Minimum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmin,E1246,D10,milk)
Minimum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmin,E1247,D10,milk)
Minimum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmin,E494,D10,milk)
Minimum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmin,E506,D10,milk)
Minimum SNAC milk concentration during a dosing interval after the 10th dosing (Cmin,SNAC,D10,milk)
Minimum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmin,sema,D10,milk)
Relative daily infant SNAC dose
Relative daily infant semaglutide dose
Time to maximum SNAC metabolite E1245 milk concentration after the 10th dosing (tmax,E1245,D10,milk)
Time to maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (tmax,E1245,D10,plasma)
Time to maximum SNAC metabolite E1246 milk concentration in milk after the 10th dosing (tmax,E1246,D10,milk)
Time to maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (tmax,E1246,D10,plasma)
Time to maximum SNAC metabolite E1247 milk concentration after the 10th dosing (tmax,E1247,D10,milk)
Time to maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (tmax,E1247,D10,plasma)
Time to maximum SNAC metabolite E494 milk concentration after the 10th dosing (tmax,E494,D10,milk)
Time to maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (tmax,E494,D10,plasma)
Time to maximum SNAC metabolite E506 milk concentration after the 10th dosing (tmax,E506,D10,milk)
Time to maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (tmax,E506,D10,plasma)
Time to maximum SNAC milk concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,milk)
Time to maximum SNAC plasma concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,plasma)
Time to maximum semaglutide milk concentration during a dosing interval after the 10th dosing (tmax,sema,D10,milk)
Time to maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (tmax,sema,D10,plasma)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Oral semaglutide

This trial requires 14 total participants across 2 different treatment groups

This trial involves 2 different treatments. Oral Semaglutide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Oral semaglutide
Drug
All participants will receive oral semaglutide once daily for a total of 10 days: 3 mg for 5 days followed by 7 mg for 5 days.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from 0 to 24 hours after the 10th dosing (day 10)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from 0 to 24 hours after the 10th dosing (day 10) for reporting.

Closest Location

Novo Nordisk Investigational Site - San Antonio, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Healthy, female subjects who have given birth at least 3 months prior to screening and who breastfeed (breastfeeding is defined by feeding the baby milk produced by the mother. Using a breast pump to collect milk and subsequently feeding it to the baby by bottle, is also defined as breastfeeding ) their infant to an extent, where the majority of the infant's total energy intake is from breastfeeding and sufficient milk is produced to fulfil the trial requirements, as judged by the investigator.
Agree to abstain from breastfeeding their infant from first dose of oral semaglutide to the "End of trial" visit (total of 47 days) to avoid potentially exposing their child to semaglutide and SNAC.
The breastfed infant is able to feed from a bottle (expenses related to alternative infant nutrition during trial participation will be covered by Novo Nordisk) prior to screening.
Age above or equal to 18 years at the time of signing informed consent.
Body mass index (BMI) between 20.0 and 32.4 kg/m^2 (both inclusive).

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get diabetes mellitus, type 2 a year in the United States?

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Estimated [adult] diabetes prevalence trends will be presented annually based on nationally representative surveys from different sources, such as the NHANES Program. The estimates of diabetes prevalence may serve as a means of monitor surveillance and evaluating of diabetes control. (Cancer 2010). Diabetes is an important part in health problems because it produces high blood sugar levels that may interfere with the body's ability to process food, or can cause serious complications. Diabetes can come in different forms, such as Type 1 and Type 2. Type 1 is the most common form of diabetes mellitus. Type 2 diabetes mellitus often goes unnoticed until it has already progressed.

Unverified Answer

What are common treatments for diabetes mellitus, type 2?

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In this cross-sectional study of patients with [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes), only one-fourth were screened for retinopathy; no other cardiovascular risk factors were measured. This may be because these patients did not recognize their diabetes for many years, and were screened only after a diagnosis of retinopathy was made by a specialist.

Unverified Answer

What causes diabetes mellitus, type 2?

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Results from a recent clinical trial indicate that genetics, lifestyle, environmental factors, and endocrine milieu play a role in the metabolic abnormalities leading to type 2 diabetes mellitus.

Unverified Answer

What are the signs of diabetes mellitus, type 2?

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The onset of diabetes can be detected through non-specific symptoms. For patients who are at risk, an oral glucose tolerance test (OGTT) can help detect prediabetes. In addition, HbA1c is helpful in identifying DM2.

Unverified Answer

Can diabetes mellitus, type 2 be cured?

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With modern therapy, the prognosis of DM, type 2 is improving. Diabetes, type 2 does not seem to be a disease that can definitely be cured; however, it can be controlled and patients still have a good prognosis.

Unverified Answer

What is diabetes mellitus, type 2?

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Diabetes, type II is a disease characterized by impaired fasting of blood sugar, increased urinary losses of glucose and ketones, and increased vulnerability to complications because of the disease.

Unverified Answer

Who should consider clinical trials for diabetes mellitus, type 2?

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Patients with diabetes should consider clinical trials for NIDDM or T2DM when there is a treatment option that can change the course of their disease, can prevent irreversible damage, or is expected to optimize glucose control and potentially reduce healthcare costs.

Unverified Answer

Have there been any new discoveries for treating diabetes mellitus, type 2?

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This review summarizes recent research on new discoveries for treating diabetes mellitus. This review was based on only a very brief overview of each article and additional research is still necessary to establish any new treatments or drug regimens that may offer promise.

Unverified Answer

Is oral semaglutide typically used in combination with any other treatments?

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Most patients taking semaglutide met the combination-treatment scenario for HCCA, and a minority of patients taking other medications (not met by patients taking semaglutide alone) underwent adjuvant or new-drug therapy before or after semaglutide. Patients prescribed antiretrovirals, metformin, and a statin used to be more likely to receive additional medical therapies.

Unverified Answer

What are the latest developments in oral semaglutide for therapeutic use?

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Oral semaglutide monotherapy and combination therapy with metformin provided robust reductions in glycaemia without any significant side effects, particularly in T2DM patients. Further studies are warranted with semaglutide in order to determine its potential role for improved glycaemic control in T2DM patients.

Unverified Answer

What is oral semaglutide?

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In patients with type 2 diabetes, a single dose of oral semaglutide 100 mg is associated with rapid and sustained reductions in HbA1c, HOMA-ins, 2H-Glu, fasting F2-isoprostane, and F2-iso-15:0, but no increase in FFA or LDL cholesterol. The rapid and sustained HbA1c reductions suggest that a single dose of semaglutide may be effective in delaying progression of type 2 diabetes and/or minimizing the consequent cardiovascular disease risk.

Unverified Answer

Has oral semaglutide proven to be more effective than a placebo?

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Oral semaglutide is effective for achieving and maintains the metabolic response while receiving this drug, in particular in obese women. Oral semaglutide has more beneficial effects on lipid profile as compared with a placebo.

Unverified Answer
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