Semaglutide for Diabetes Mellitus, Type 2

Phase-Based Estimates
2
Effectiveness
3
Safety
Novo Nordisk Investigational Site, Bratislava, Slovakia
Diabetes Mellitus, Type 2+1 More
Semaglutide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

This study is evaluating whether a medicine may help prevent vision loss in people with diabetes.

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Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Semaglutide will improve 1 primary outcome and 21 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Week 0, Year 5.

Up to 5 years
Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye.
Week 0, Year 5
Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.
Change in body weight.
Change in glycosylated haemoglobin (HbA1c).
Change in systolic and diastolic blood pressure.
Change in visual acuity in the better seeing eye.
Change in visual acuity in the worse seeing eye.
Week 0-Year 5
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.
Year 5
Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.
Presence of at least 2 steps ETDRS subject level improvement.
Presence of at least 2 steps ETDRS subject level progression.
Presence of at least 3 steps ETDRS subject level improvement.
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
Presence of ciDME in either eye.
Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.
Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.
Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.
Presence of persistent visual acuity up to 38 ETDRS letters in either eye.

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Side Effects for

Overall Study
Nausea
21%
Decreased Appetite
12%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Placebo
Semaglutide
Placebo group

This trial requires 1500 total participants across 2 different treatment groups

This trial involves 2 different treatments. Semaglutide is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Semaglutide
Drug
Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
Placebo
Drug
Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: year 5
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly year 5 for reporting.

Closest Location

Novo Nordisk Investigational Site - Asheville, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) is evaluated by fundus photography and confirmed by central reading centre. show original
No one with diabetic retinopathy or diabetic macular oedema can have any type of eye treatment done six months before the screening. show original
was required No laser treatment was needed for their previous pan-retinal photocoagulation. show original
Male or female participants who are at least 18 years old are able to consent to participate in this study. show original
I was diagnosed with type 2 diabetes mellitus. show original
People with diabetes who have an HbA1c of 7.0-10.0% (53-86 mmol/mol) have a high risk for heart attack, stroke, and other problems. show original
There was no anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation. show original
The person has a visual acuity of 30 letters or more using the ETDRS visual acuity protocol. show original
No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial
No substantial media opacities that would preclude successful imaging

Patient Q&A Section

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

What causes diabetes mellitus, type 2?

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Diabetics with long-term insulin therapy should always be informed of the potential harms they may face from high-fat diet, high-fat drinking, and low levels of physical and aerobic fitness.

Unverified Answer

What are the signs of diabetes mellitus, type 2?

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In a population of young adult women, obesity is common, and its presence can be easily detected by use of a waist-to-hip ratio that is >0.9. In a population of young adult men, obesity, type 1 or diabetes, type 1 are more common than type 2 diabetes. The presence of high blood pressure or dyslipidemia is more typical in type 2 than type 1 diabetes. The presence of any of these characteristics indicate further medical evaluation for either type 1 or type 2 diabetes.

Unverified Answer

What are common treatments for diabetes mellitus, type 2?

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The mainstay of treatment for DM2 is blood glucose control. However, a range of additional treatments are available, which may be used to help reduce the severity of the condition and reduce the risk of cardiovascular complications. One such therapy is insulin therapy.

Unverified Answer

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

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This is an accurate assessment of the actual number of people and their number of encounters with type 2 diabetes. Each year, between 27.5 and 29.0 million Americans have type 2 diabetes.

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Can diabetes mellitus, type 2 be cured?

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The prevalence of diabetes increases with age in many indigenous communities. In an Indigenous population, the prevalence of diabetes type 2 doubles after 50 years of age. In younger subjects, who have the highest incidence of diabetes, the rate falls off between ages 24-34 to 30-44 and then again starts to increase in the 45-60 age group. The prevalence of diabetes in those age groups suggests a significant decrease in the prevalence in the 45-60 group, but the low prevalence in the older age group at ages 61-74 suggests no decrease in prevalence over a 50 year period. This pattern suggests a cure by longevity of diabetes in those with younger prevalence.

Unverified Answer

What is diabetes mellitus, type 2?

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Diabetes is caused by either a lack of production of insulin by the pancreas or by a lack of use of insulin, either of which results in abnormal sugar levels. Diabetes affects all parts of the body. Signs and symptoms of the disease are usually subtle but can be debilitating when left untreated. Diabetes can have an impact on all people, however, those with a family history are at a higher risk.\n

Unverified Answer

Does diabetes mellitus, type 2 run in families?

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The high frequency of DM2 in our patient population, combined with the findings of a family history of DM2, further indicates the existence of autosomal dominant transmission with high penetrance for this trait in both probands and their offspring.

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What is semaglutide?

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Semaglutide is a diabetes treatment agent approved by the FDA for the treatment of diabetes. When semaglutide is injected subcutaneously (under the skin) it is often used by people with type 2 diabetes who have failed to achieve tight blood glucose control and have been forced to add daily insulin injections, often on an additional schedule. In a subset of patients, semaglutide has been shown to reduce the number of injections required for good blood glucose control. People using semaglutide have fewer daily insulin injections than they had in the days when they used insulin plus oral medications alone.

Unverified Answer

Does semaglutide improve quality of life for those with diabetes mellitus, type 2?

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Semaglutide significantly improved a range of QoL outcomes, especially when compared with a matched comparator group from the T2D-TMM. Semaglutide improved HRQoL in the domains of physical functioning, bodily pain, and general health. The impact of semaglutide on HRQoL was sustained, with improvements observed for all domains after 3 years.

Unverified Answer

Have there been other clinical trials involving semaglutide?

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Semaglutide has been investigated in at least two clinical trials for the treatment of type 2 diabetes published in scientific journals. However, as of March 31, 2016, the National Institute for Health and Clinical Excellence had not formally evaluated the data collected in these studies. As of September 2017, this situation remains unchanged. It is therefore recommended that further research be done on semaglutide before a decision on a treatment policy for type 2 diabetes is made.\n\nSemaglutide, a short acting analogue of glucagon-like peptide 1, which stimulates insulin secretion, was developed and approved by the US Food and Drug Administration in August 2014.

Unverified Answer

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

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With regard to treating diabetes mellitus, type 2, the majority of studies have failed to demonstrate an anti-diabetic treatment which reduces the risk of complications associated with diabetes mellitus, type 2, in a substantial number of patients. The majority of published studies with respect to diabetes and weight loss have had methodological weaknesses. No conclusive evidence has been found to recommend or recommend against specific dietary or non-dietary interventions for modifying metabolic control in diabetes, type 2. Larger, more rigorous studies are needed to produce high-quality evidence for or against certain dietary or non-dietary interventions in the management of diabetes mellitus, type 2.

Unverified Answer

Has semaglutide proven to be more effective than a placebo?

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The Semaglutide is associated with a marked improvement in HbA1c compared with a placebo (1.4% [0.2] to 1.6% [0.2]; P<0.0001) when treated in people with diabetes mellitus type 2 without previously treated inpatient or outpatient hyperglycaemia.

Unverified Answer
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