- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
NIH Funds Studies to Improve Prediabetes and Type 2 Diabetes Treatment
Trials for adults and youth compare treatments in newly diagnosed subjects (May 22)
The National Institutes of Health (NIH) is looking for volunteers to participate in one of three clinical trials to improve and preserve the production of insulin in people with prediabetes or recently diagnosed type 2 diabetes. The project is called the RISE (Restoring Insulin SEcretion) study.
Two trials will examine adults; the other will look at youth. Each of the studies will be conducted for 5 years. Treatments with the most promising results may be tested in larger, definitive trials, the NIH says.
One study in adults will investigate weight loss using a gastric band that narrows food’s access to the stomach in comparison with standard advice and metformin, the drug most commonly used to treat early diabetes. The trial aims to enroll 88 subjects at the University of Southern California, Los Angeles.
The second study in adults will compare placebo with three FDA-approved drug regimens for type 2 diabetes: metformin alone; metformin plus liraglutide (a drug that increases the amount of insulin released in response to nutrients); and glargine (a long-acting insulin that would be used for 3 months before switching to metformin). The trial aims to enroll 255 subjects at the VA Puget Sound Health Care System and the University of Washington, both in Seattle; at Indiana University, Indianapolis; and at the University of Chicago.
The study in youth, which aims to enroll 90 subjects aged 10 to 19 years, will compare metformin with glargine. Glargine would be used for 3 months before switching to metformin. The trial will be conducted at the Children’s Hospital Colorado and the University of Colorado, both in Aurora; at the Children’s Hospital of Pittsburgh; at Yale University, New Haven, Conn.; and at Indiana University, Indianapolis.
Source: NIH; May 22, 2013.