TrialWatch

Advanced Medical Therapy versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

ClinicalTrials.gov Identifier: NCT00432809

In the treatment of type 2 diabetes and obesity, one approach that is gaining popularity is bariatric surgery. Bariatric surgery treats obesity by either restricting the amount of food a person can eat, by reducing the ability of the intestine to absorb nutrients, or both. Interestingly, however, some types of bariatric surgery are more effective at treating type 2 diabetes than doctors would guess based on weight loss alone. In this study, two types of bariatric surgery are being compared, laparoscopic Roux-en-Y Gastric Bypass (RYGBP) and laparoscopic sleeve gastrectomy. In RYGBP surgery, the majority of the stomach and part of the small intestine are bypassed by surgically connecting a section of the stomach with the small intestine. As a result, not as much food can be ingested and there is reduced absorption of nutrients by the small intestine. Laparoscopic sleeve gastrectomy removes a large portion of the stomach, but leaves it and the entire small intestine functionally intact. Because the stomach is smaller,,not as much food can be ingested. Both of these types of surgery have been shown to cause weight loss, but to date there has been no in-depth scientific study to determine which is more effective at resolving type 2 diabetes. To be considered for this study, patients must have type 2 diabetes with an A1c of more than 7.5% and a BMI of greater than 27 and less than 43 kg/m2. For information about enrolling in the trial, contact Chytaine Hall by email or by phone at 216-445-3983. Learn more about bariatric surgery.

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

ClinicalTrials.gov Identifier: NCT00680745

This study investigates the efficacy and safety of dapagliflozin, a new type of medication for type 2 diabetes. Dapagliflozin is an inhibitor of an enzyme called SGLT-2, which is responsible for removing glucose from the urine and putting it back into the bloodstream. By blocking SGLT-2, dapagliflozin increases glucose excretion in the urine and lowers blood glucose levels. The study is testing dapagliflozin in addition to the sulfonylurea glimepiride (commonly known as Amaryl or Diapride) compared to glimepiride alone. To be included in the study, you must be older than 18 years of age, have type 2 diabetes with an A1c between 7.0%-10.0%, and currently taking a sulfonylurea like Amaryl or Diapride. You are not eligible if you have type 1 diabetes, liver disease, or kidney failure or dysfunction. This study will be analyzing changes in A1c, body weight, blood glucose levels, and will monitor the side effects of dapagliflozin. Once in the study, you will be randomized to one of four treatment arms: placebo + glimepiride, 2.5 mg of dapagliflozin + glimepiride, 5 mg of dapagliflozin + glimepiride, or 10 mg of dapagliflozin + glimepiride. The study lasts for 48 weeks. Click here to email the company for more information. As we understand it, even though this study isn’t for people with type 1, this class of medicine is being tested in type 1 patients.

A Study of Taspoglutide versus Exenatide for the Treatment of Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin, Thiazolidinedione or a Combination of Both.

ClinicalTrials.gov Identifier: NCT00717457

We think that one of the most promising drug classes available to treat type 2 diabetes is the glucagon-like peptide (GLP-1) analogs. GLP-1 is a hormone produced in the intestines that helps to regulate insulin secretion and glucose metabolism, and it helps to lower blood sugar levels while also producing weight loss. This study compares the safety and efficacy of a new GLP-1 analog, taspoglutide, to exenatide (Byetta). To be eligible for this study you must be between 18 to 75 years of age and have type 2 diabetes with an A1c between 7.0%-10.0%. You must have been on metformin and/or pioglitazone (Actos) or rosiglitazone (Avandia) for at least 12 weeks. Lastly, you must have a BMI between 25 kg/m2 and 45 kg/m2 (or between 23 and 45 kg/m2 if you’re Asian) and have maintained a stable weight for at least 12 weeks prior to screening. If you enroll, you will be randomized to receive taspoglutide once per week or exenatide twice daily. Both medications need to be injected. During the study, researchers will measure changes in your A1c, body weight, natural insulin production, and a subset of patients will also be monitored for changes in glucose, insulin, c-peptide, and glucagon levels during a meal tolerance test. For more information, please call 1-800-526-6367.

PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)

ClinicalTrials.gov Identifier: NCT00729365

People with type 1 diabetes have a high chance of developing kidney disease, which is usually associated with high blood pressure. Kidney disease can be partially treated with blood pressure-lowering medication, but by the time this treatment is begun, there may already be kidney damage. The PREVENTKD study is designed to answer two main questions: can future kidney disease be predicted with high nighttime blood pressure, and does early treatment with drugs called ACE inhibitors in people with type 1 diabetes and high blood pressure lower the risk of kidney disease? The study will randomize patients into three patient groups: patients who have normal nighttime blood pressure who are given a placebo, patients with high nighttime blood pressure who are given a placebo, and patients with high nighttime blood pressure who are given the ACE inhibitor ramipril (Tritace/Ramace or Altace). Patients will be assessed for kidney disease every three to six months for five years after being randomized to one of these groups. To be included in this study, patients must have type 1 diabetes (confirmed by C peptide measurement), duration of diabetes between 5 and 28 years, and normoalbuminuria (healthy kidneys). Patients in the study must be between 13 and 50 years old. To enroll, contact Daniel Batlle, MD by email or by phone at 312-908-8342.