Metformin DR for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Carolina Institute for Clinical Research, Fayetteville, NC
Diabetes Mellitus, Type 2+1 More
Metformin DR - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new way of delivering metformin may help improve blood sugar control in patients with type 2 diabetes and kidney disease.

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 Metformin DR will improve 1 primary outcome and 3 secondary outcomes in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of Baseline to 28 weeks.

Baseline to 28 weeks
Change in HbA1c
Change in HbA1c (Met DR vs. metformin IR)
HbA1c response (Metformin DR vs. metformin IR)
HbA1c response (Metformin DR vs. placebo)

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

3 Treatment Groups

Active Control Arm (Metformin DR placebo plus metformin IR)
1 of 3
Investigational Arm (Metformin DR plus metformin IR placebo)
1 of 3
Placebo Arm (Metformin DR placebo plus metformin IR placebo)
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 675 total participants across 3 different treatment groups

This trial involves 3 different treatments. Metformin DR 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.

Investigational Arm (Metformin DR plus metformin IR placebo)Group A will receive 1800 mg Metformin DR qAM + placebo for 1500 mg metformin IR in divided doses (2×placebo for metformin IR 500 mg qAM and 1×placebo for metformin IR 500 mg qPM).
Placebo Arm (Metformin DR placebo plus metformin IR placebo)Group B will receive placebo for 1800 mg Metformin DR qAM + placebo for 1500 mg metformin IR in divided doses (2× placebo for metformin IR 500 mg qAM and 1×placebo for metformin IR 500 mg qPM).
Active Control Arm (Metformin DR placebo plus metformin IR)Group C will receive placebo for 1800 mg Metformin DR qAM + 1500 mg metformin IR in divided doses (2× metformin IR 500 mg qAM and 1× metformin IR 500 mg qPM).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 28 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 28 weeks for reporting.

Closest Location

Carolina Institute for Clinical Research - Fayetteville, 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:
Is male or female and at least 18 years old
Has body mass index 20.0 to 45.0 kg/m2 (inclusive)
Has T2DM
Has HbA1c of 7.0% to 9.5%, inclusive, at Visit 1A and HbA1c value of 7.0% to 10.5%, inclusive, at Week -2 (Visit 3/3A as applicable)
Has an eGFR value of ≥30 mL/min/1.73 m2 based on the CKD-EPI equation at Visit 1A and Visit 3/3A (Week -2)
Stable treatment with a metformin preparation or a combination product containing metformin for 8 weeks prior to Visit 1A
If treated with the following medications, must be on a stable regimen for a minimum of 6 weeks prior to Visit 1B
Drugs known to affect body weight, including prescription medications (e.g., phentermine, phentermine/topiramate, orlistat, lorcaserin, bupropion/naltrexone) and over-the-counter anti-obesity agents
Hormone replacement therapy (female patients) and testosterone (male patients)
Oral contraceptives (female patients)

Patient Q&A Section

Is metformin dr typically used in combination with any other treatments?

"Metformin, in combination with other drugs, is typically used to treat patients with T2DM. The use of metformin, in combination with other drugs, is commonly prescribed." - Anonymous Online Contributor

Unverified Answer

What are the signs of diabetes mellitus, type 2?

"The signs of diabetes mellitus, type 2 include high blood sugar, feeling tired/mood swings, increased urination, pale complexion, frequent urination, decreased weight and increased thirst." - Anonymous Online Contributor

Unverified Answer

What is diabetes mellitus, type 2?

"Diabetes mellitus, type 2 is characterized by increased risk for cardiovascular events and peripheral neuropathy. These complications are associated with a high level of proinflammatory mediators and activation of the endothelium. Current data indicate that activation of circulating endothelial progenitor cells (EPCs) by [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) is a major culprit in triggering high level of C-reactive protein (CRP). CRP is a surrogate marker for the inflammatory activity of endothelial cells and predicts cardiovascular events as well as nephropathy. Thus, targeting CRP level may be beneficial for preventing diabetic cardiovascular complications. In the present study we show for the first time that EPCs express functional receptors for CRP." - Anonymous Online Contributor

Unverified Answer

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

"Diabetes is common in the United States. The American Diabetes Association reported an estimated 114 million U.S. citizens had diabetes in 2007. In 2007, an estimated 45% of the population had diabetes. The average age for onset of diabetes and related health problems was 40.9 years. In 2007, the estimated average medical cost for diabetes in the United States in 2007 was $10,835 per person per year. Diabetes affects more affluent Americans than those in poverty." - Anonymous Online Contributor

Unverified Answer

What causes diabetes mellitus, type 2?

"Type 2 diabetes can occur due to a number of factors which affect insulin sensitivity. It causes the most micro- and macro-vascular complications of diabetes and is the largest and most costly cause of non-insulin-dependent diabetes. Diabetes type 2 should therefore be managed to prevent these complications." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes mellitus, type 2?

"Diabetes has a substantial impact on patient lives, causes significant financial losses and has proven to be self-sustaining. Patients with diabetes are generally managed by a multidisciplinary team with specialist nurses, dietitians, podiatrists and optometrists playing a role. The overall aim of the multidisciplinary team is to ensure that all patients have adequate and appropriate foot care. This is the first step in the prevention and management of diabetes-related foot disease. There are two main types of foot care: prevention and treatment. Prevention refers to the control of risk factors for diabetic foot disease by lowering blood pressure, control blood sugar, regular check-ups and footwear." - Anonymous Online Contributor

Unverified Answer

Can diabetes mellitus, type 2 be cured?

"Diabetes-type 2 is a chronic non-life threatening disease that can be effectively treated with lifestyle modification, and, when well managed, can improve overall health and quality of life. Lifestyle adjustments in terms of diet, physical activity and appropriate management of oral antihypertensive medication can improve insulin sensitivity, glycaemic control and reduce the risk of cardiovascular morbidities." - Anonymous Online Contributor

Unverified Answer

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

"In a recent study, findings suggest that the use of metformin for a median of 6 years resulted in the greatest improvement in quality of life. In a recent study, findings of this study reinforce the emerging consensus, in the medical literature, that clinicians should advise patients with DM, type 2 about the potential role of metformin on QOL." - Anonymous Online Contributor

Unverified Answer

How does metformin dr work?

"No statistically significant difference between patients treated with metformin and those not treated was demonstrated. Additional studies are required to see whether metformin would be as efficacious when used in the adjunctive treatment of diabetic patients treated with glucocorticoid or immunosuppressive agents." - Anonymous Online Contributor

Unverified Answer

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

"Individuals with well-controlled type 2 diabetes are at a high risk for atherosclerotic cardiovascular disease, and clinical trial design should take these factors into account." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of diabetes mellitus, type 2?

"In the United States, individuals with diabetes mellitus, type 2, and overweight constitute the majority of individuals diagnosed with the disease. To avoid developing diabetes mellitus type 2, obesity, which is directly linked to diet choices and exercise, must be avoided." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in metformin dr for therapeutic use?

"The use of metformin is often limited by adverse side effects, particularly diarrhoea, nausea and/or vomiting. Although newer formulations of metformin may overcome these adverse effects, the development of metformin to achieve therapeutic plasma concentration will still require improvement in the oral bioavailability of metformin to be clinically effective in type 2 diabetes mellitus." - 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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