Diabetes (Type 2)

About Diabetes (Type 2) Clinical Trials (Click to Open)

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Type 2 Diabetes

General Purpose: 

Diabetes refers to a chronic condition that impairs the way an individual’s body metabolizes its main source of fuel – glucose (i.e., “blood sugar”). Type 2 diabetes develops when the body becomes resistant to the effects of insulin (a hormone produced by the pancreas that regulates the amount of glucose in the blood), or when it fails to produce sufficient amounts of insulin to maintain normal blood glucose levels.

If left untreated, type 2 diabetes can be fatal. No one knows for certain why type 2 diabetes occurs, but excess body weight and physical inactivity are known to be associated with its onset.

Other risk factors associated with type 2 diabetes include family history of the disease, race and ethnicity (African Americans, Hispanics, American Indians, and Asian-Americans are more likely to develop type 2 diabetes than whites), and increasing age.

In addition, individuals who have a condition known as prediabetes, in which blood sugar is elevated but not high enough to be diagnosed as type 2 diabetes, also face an increased risk of diabetes, as prediabetes can progress into type 2 if not properly treated.

Finally, women who develop diabetes during pregnancy (gestational diabetes) also have an increased risk of developing type 2 diabetes later in life.

For most people, type 2 diabetes can be successfully managed through thoughtful and diligent lifestyle modifications that include dietary and activity-related changes. For some, medication may also be needed to supplement behavioral modifications.

Nevertheless, type 2 diabetes still carries with it the risk of long-term complications, many of which can develop gradually over long periods of time. These complications include cardiovascular disease, damage to the nerves, kidneys, eyes, feet, and skin. Furthermore, type 2 diabetes can lead to the development of gum infections and osteoporosis. Some research suggests that it may also increase the risk of developing Alzheimer’s disease and other forms of dementia.

If you are one of the nearly 20 million people in the United States who have been diagnosed with diabetes, you may be seeking out a clinical trial in the hope of finding a better means of managing your disease, minimizing complications, or simply to contribute to the overall research effort.

The diabetes research industry is massive, with the U.S. government spending over $1 billion annually on diabetes-related research. Some of the topics currently being investigated include: more accurate methods of diagnosing diabetes; evaluating the impact of specific nutrients (such as carbohydrates) on the development, progression and treatment of type 2 diabetes; using cell-based therapies to help the body re-learn to produce insulin on its own; and investigating the relationship between type 2 diabetes and its numerous complications, in an effort to develop more effective methods of preventing them from occurring. 

What Will Type 2 Diabetes Clinical Trials Be Like?

The types of tests and assessments used in type 2 diabetes clinical trials will ultimately depend on the specific nature of the study and what aspects of type 2 diabetes are being investigated. Provided below is a list of frequent procedures and tests that may be incorporated for use in clinical trials: 

  • Physical exam
  • Glycated hemoglobin test (A1C test): a blood test that indicates an individual’s average blood sugar level over the prior two months.
  • Random, standard blood sugar tests that measure the amount of glucose in the blood at a particular point in time.
  • Fasting blood sugar tests that measure blood sugar levels following an overnight fast.
  • Oral glucose tolerance tests: this test involves overnight fasting, followed by a fasting blood sugar test, then consumption of a sugary liquid. Blood sugar levels are then tested periodically over the following few hours.
  • Blood tests to monitor cholesterol levels.
  • Nerve conduction tests to monitor the health of nerves, especially in the feet.
  • Eye tests
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as food and/or exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Type 2 Diabetes Clinical Trial Protocol:

Specific examples of clinical trials for type 2 diabetes might include the following:

  • A randomized study to determine if a commercial weight-loss program modified for use by individuals with type 2 diabetes leads to greater improvements in blood glucose control when compared to a control group of patients with type 2 diabetes who receive standard diabetes counseling.
  • A randomized clinical trial in which obese subjects with type 2 diabetes are randomly assigned to receive treatment with a newly-develop drug designed to help the body produce more insulin, or to receive a placebo. Such a study would evaluate the safety and tolerability of the new drug as measured by the number of adverse side effects experienced by subjects in each group.
  • A study designed to evaluate the safety and effectiveness of two weight loss surgeries for morbidly obese individuals with type 2 diabetes, compared to a group of morbidly obese subjects with type 2 diabetes who receive intensive lifestyle modification therapy. Subjects in this study would be followed over a two-year period to compare the effects of these three treatments on their type 2 diabetes.
  • A study in which 8th grade students at 20 middle schools receive an intervention that integrates type 2 diabetes prevention education through four means: the school nutrition environment, physical education department, behavior change initiatives, and educational activities. The purpose of this study would be to determine if, over the course of a school year, participating students showed improvements in their body mass index (a measure of body composition), fasting glucose, and fasting insulin levels. 

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment (such as the first example listed above).

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time (such as the second example provided above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your history of diabetes, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your most recent A1C measurement
  • Your family history of diabetes
  • Your prior history of treatment for diabetes and other medical conditions (including any surgeries, procedures, and medications)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels (if known)

Suggested Search Terms:

 “type 2 diabetes children,” “type 2 diabetes therapy,” “type 2 diabetes treatment,” “type 2 diabetes obesity,” “type 2 diabetes exercise,” “type 2 diabetes complications,” “type 2 diabetes management,” “type 2 diabetes genetics,” and “type 2 diabetes prevention.”

Current Search Term:

“Diabetes (Type 2)”

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A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure

Condition:   Diabetes Type 2 With Heart Failure
Interventions:   Drug: LIK066;   Drug: Placebo;   Drug: Empagliflozin
Sponsor:   Novartis Pharmaceuticals
Not yet recruiting - verified May 2017

Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes

Condition:   Diabetes Type 2
Interventions:   Behavioral: Intervention arm: Person-centred interactive self-management support;   Other: Control arm;   Other: External comparison group
Sponsors:   Umeå University;   The Swedish Diabetes Foundation;   The County Council of Västerbotten
Recruiting - verified May 2017

Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients

Condition:   Type 2 Diabetes
Sponsor:   AstraZeneca
Recruiting - verified May 2017

The Application of the E-health Education on Shared Care Program for Patients With Type 2 Diabetes

Condition:   Type 2 Diabetes Mellitus
Interventions:   Behavioral: E-health Education;   Other: Routine care
Sponsor:   Li-Li Chen
Recruiting - verified February 2017

Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable Therapy

Condition:   Diabetes Mellitus Type 2
Sponsors:   AstraZeneca;   Truven health
Completed - verified January 2017

Mineralocorticoid Receptor Antagonists in Type 2 Diabetes

Condition:   Diabetes Type 2
Interventions:   Drug: Eplerenone;   Drug: Placebo
Sponsor:   Herlev Hospital
Active, not recruiting - verified May 2017

Defining the Physiological Mechanisms of Risk Genes for Hyperglycaemia, Insulin Resistance and Type 2 Diabetes

Condition:   Type 2 Diabetes
Interventions:   Other: 4 Hour Frequently Sampled Oral Glucose Tolerance Test;   Other: Isoglycaemic Clamp
Sponsors:   University of Oxford;   University of Exeter;   Medical Research Council
Recruiting - verified June 2016

Impact of Rheumatoid Arthritis on the Course of Type 2 Diabetes During a Longitudinal Follow-up of 5 Years

Condition:   Type 2 Diabetes
Sponsors:   Assistance Publique - Hôpitaux de Paris;   Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Recruiting - verified June 2016

Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2

Conditions:   Chronic Periodontitis;   Diabetes Type 2
Interventions:   Device: Mechanical periodontal therapy;   Procedure: nonsurgical periodontal therapy
Sponsors:   University of Brasilia;   Catholic University of Brasília;   Brasilia University Hospital
Active, not recruiting - verified May 2017

Effects of Prebiotics on GLP-1 in Type 2 Diabetes

Condition:   Diabetes Type 2
Interventions:   Dietary Supplement: Prebiotic fibers: oligofructose and inulin;   Dietary Supplement: Maltodextrin
Sponsors:   Oslo University Hospital;   Norwegian Diabetes Association;   Norwegian Extra Foundation for Health and Rehabilitation
Recruiting - verified April 2017

Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus

Condition:   Diabetes Type 2
Interventions:   Drug: ORMD-0801;   Drug: Placebo Comparator
Sponsors:   Oramed, Ltd.;   Integrium
Completed - verified December 2016

Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2

Condition:   Type 2 Diabetes
Intervention:   Device: Combination pulsatile Stendo3
Sponsors:   University Hospital, Clermont-Ferrand;   STENDO, 17 rue du port 27400 LOUVIERS
Recruiting - verified July 2016

DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Settings

Condition:   Type 2 Diabetes Mellitus
Sponsor:   AstraZeneca
Active, not recruiting - verified March 2017

DISCOVERing Treatment Reality of Type 2 Diabetes in Real World Setting in Japan

Condition:   Type 2 Diabetes Mellitus
Sponsors:   AstraZeneca;   Ono Pharmaceutical Co. Ltd
Active, not recruiting - verified April 2017

Study of Chiglitazar Compare With Placebo in Type 2 Diabetes Patients

Condition:   Type 2 Diabetes
Interventions:   Drug: Chiglitazar;   Drug: Placebo
Sponsor:   Chipscreen Biosciences, Ltd.
Active, not recruiting - verified February 2017

Diet and Exercise Intervention in Type 2 Diabetes

Condition:   Type 2 Diabetes
Interventions:   Behavioral: Optimum Lifestyle Intervention;   Behavioral: Standard Care
Sponsors:   Washington University School of Medicine;   National Dairy Council;   American Egg Board
Completed - verified April 2017

Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care

Condition:   Type 2 Diabetes
Interventions:   Other: Remote, personalized type 2 diabetes care.;   Other: Usual Endocrine care.
Sponsor:   University of Michigan
Active, not recruiting - verified April 2017

Postpartum Screening of Type 2 Diabetes

Condition:   Type 2 Diabetes
Intervention:   Procedure: oral glucose tolerance test 2 days post-partum
Sponsors:   Université de Sherbrooke;   The Lawson Foundation
Active, not recruiting - verified December 2016

Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

Condition:   Type-2 Diabetes Mellitus
Interventions:   Drug: LAF237 (vildagliptin);   Drug: Metformin
Sponsor:   Novartis Pharmaceuticals
Completed - verified April 2017

Early Intermittent Intensive Insulin Therapy as an Effective Treatment of Type 2 Diabetes (RESET-IT Pilot Study)

Condition:   Type 2 Diabetes
Interventions:   Drug: Intermittent insulin therapy;   Drug: Continuous metformin
Sponsors:   Mount Sinai Hospital, Canada;   Canadian Institutes of Health Research (CIHR)
Active, not recruiting - verified March 2017

Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.

Condition:   Type 2 Diabetes Mellitus
Interventions:   Drug: LAF237;   Drug: Protaphane
Sponsor:   Novartis Pharmaceuticals
Completed - verified November 2016

Exercise Study on Cardiac Function in Patients With Diabetes Mellitus Type 2 and Diastolic Dysfunction

Condition:   Diabetes Type 2
Intervention:   Other: Exercise
Sponsor:   Norwegian University of Science and Technology
Completed - verified April 2017

Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity

Condition:   Type II Diabetes
Interventions:   Device: EndoBarrier;   Behavioral: Diet + Lifestyle Counseling
Sponsor:   GI Dynamics
Completed - verified August 2016

Study for Pre-Surgical Weight Loss in Type II Diabetes Patients

Condition:   Type 2 Diabetes
Intervention:   Device: GI Sleeve
Sponsor:   GI Dynamics
Completed - verified March 2016

Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes

Condition:   Diabetes Type 2
Intervention:   Drug: Aliskiren
Sponsor:   Novartis
Completed - verified September 2016

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