IcoSema for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novo Nordisk Investigational Site, Jacksonville, FL
Diabetes Mellitus, Type 2+1 More
IcoSema - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new medicine can control blood sugar levels in people with type 2 diabetes.

See full description

Eligible Conditions

  • Diabetes Mellitus, Type 2

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Diabetes Mellitus, Type 2

Study Objectives

This trial is evaluating whether IcoSema will improve 1 primary outcome and 10 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of From baseline week 0 (V2) to week 52 (V54).

Week 52
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
Change in HbA1c
Change in body weight
Change in fasting plasma glucose (FPG)
Week 57
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of severe hypoglycaemic episodes (level 3)
Week 52
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Week 52
Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Week 52
Weekly insulin dose (total)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Diabetes Mellitus, Type 2

Trial Design

2 Treatment Groups

Insuling glargine/insulin aspart
1 of 2
IcoSema
1 of 2
Active Control
Experimental Treatment

This trial requires 680 total participants across 2 different treatment groups

This trial involves 2 different treatments. IcoSema 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 3 and have had some early promising results.

IcoSema
Drug
Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.
Insuling glargine/insulin aspartParticipants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from week 50 (v52) to week 52 (v54)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from week 50 (v52) to week 52 (v54) for reporting.

Closest Location

Novo Nordisk Investigational Site - Jacksonville, FL

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:
DPP-4 inhibitors(a)
Sodium-glucose co-transporter 2 inhibitors
Alpha-glucosidase-inhibitors
Meglitinides (glinides)(a)
Male or female and age above or equal to 18 years at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
Metformin
Sulfonylureas(a)
Thiazolidinediones

Patient Q&A Section

What causes diabetes mellitus, type 2?

"Diabetes mellitus, type 2 (diabetes mellitus, type 2) is thought to involve multiple causes, including an increased susceptibility to beta-cell failure and an excess of beta-cell destruction. Other factors that could contribute to deterioration of islet function and increase risk for diabetes mellitus, type 2 include insulin resistance and alterations in the composition of the gut microbiome. Diabetes mellitus, type 2 can also be associated with an increased risk of atherosclerosis, hypercholesterolemia, and impaired microvascular blood flow.\nPatients who develop diabetes will likely need to follow a special dietary plan (diet). Dietary counseling will guide individuals to make changes in food choices and caloric intake." - Anonymous Online Contributor

Unverified Answer

What is diabetes mellitus, type 2?

"Diabetes is a metabolic disease characterized by insulin resistance, hyperglycemia, and a tendency toward dyslipidemia. Diabetes is a global epidemic that is expected to increase dramatically with lifestyle changes and increase with greater population growth. In the USA, there were approximately 7 million new cases of diabetes annually. type 2 diabetes mellitus is the most common type of diabetes mellitus." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes mellitus, type 2?

"Although medication therapy is effective for correcting metabolic imbalances, many patients cannot maintain adequate glucose parameters and require frequent follow-up. The major problem in diabetes mellitus, type 2, treatment is the development of cardiovascular complications. Many physicians will focus on the control of hyperglycemia, but in many cases it is insufficient. In addition, treatment of this disease should include the prevention and control of hypertension and, in diabetic renal failure, lipid-based therapies. In summary, we must be aware of the importance of not only metabolic control but also of cardiovascular issues." - Anonymous Online Contributor

Unverified Answer

What are the signs of diabetes mellitus, type 2?

"There are a number of reasons why patients of any age and sex are encouraged to be screened for diabetes mellitus, type 2. Although the absolute risk of developing diabetes in those with undiagnosed diabetes is small, it is reasonable for them to pay careful attention to their diet and exercise habits. Screening for risk factors is also of immense importance. Therefore, the American Diabetes Association and Diabetes in Canada recommend that all adults be screened for the condition on an annual basis. Screening for diabetes is more effective, cheaper, and certainly more convenient when it is performed with a quick and accurate test such as fasting plasma glucose. Even after it is identified, a medical treatment can sometimes prevent this disease." - Anonymous Online Contributor

Unverified Answer

Can diabetes mellitus, type 2 be cured?

"Despite advances in treatment options for other diseases and conditions, a cure for diabetes mellitus, type 2 has yet to be discovered. However, this is not to say that the disease can not be controlled to the point where it can improve health and quality of life. While the precise benefits and risks of the different treatment options available must be weighed, a clear and balanced evaluation provides the best basis for guiding care." - Anonymous Online Contributor

Unverified Answer

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

"Approximately 8% of US men are diagnosed with type 2 diabetes. Type 2 diabetes screening in men in the population over the age of 65 is highly recommended to detect and to prevent this condition." - Anonymous Online Contributor

Unverified Answer

Does diabetes mellitus, type 2 run in families?

"Contrary to the expectation of increased familiality of diabetes in Type 2 diabetes, this study does not provide evidence for increased familiality of diabetes in Type 2 diabetes. More investigations are necessary to explain why family-wise risk is not elevated in Type 2 diabetes." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving icosema?

"There are no data specifically regarding icosema. The following applies to other diseases. One trial found no clinical significance between icosema and the placebo group in regards to the outcome measures. However, it found that icosema decreased the number of new lesions on the brain in the subjects who were treated with the drug compared to the untreated group. Studies with other pathogens, medications and drugs, other diseases, and also for different types of lesions should be carried out as a comparative study with icosema may give a better understanding of its role and impact." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets diabetes mellitus, type 2?

"Results from a recent paper sample, the average age of the development of diabetes mellitus type 2 in patients younger than 64 years was 54.0 years, compared with 51.0 years in patients older than 64." - Anonymous Online Contributor

Unverified Answer

Has icosema proven to be more effective than a placebo?

"While there is no doubt that the use of icosema led to increased A1c levels compared to the placebo group, these results showed that icosema did not differ from the placebo group in the clinical presentation of DM." - Anonymous Online Contributor

Unverified Answer

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

"The majority of diabetes therapies have involved oral or injectable agents, though there have also been some recent new discoveries including those that affect the brain. This article discusses some of the more common recent discoveries that have come forward." - Anonymous Online Contributor

Unverified Answer

What does icosema usually treat?

"Patients will present with many possible symptoms and many tests and examinations are required for diagnosis before starting treatment. The initial treatment usually focuses on relieving symptoms of patients to help them live the full term of their life in comfort before receiving further treatment. Many symptoms are very common with patients suffering from IC, making it one that requires many treatments. A doctor's assessment of all possible symptoms are usually followed by a consultation with a nurse who will give advice and prescribe treatments to help the IC disease run its own course. As an alternative to regular checks, a nurse can also measure blood glucose levels regularly to see if patients have improved." - Anonymous Online Contributor

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