RHIGF-1 GENENTECH EPIDEMIOLOGICAL PROJECT (IGEP)
Principal Investigator: Patricia A. Cleary, M.S.
The Biostatistics Center served as the Methodological and Biostatistical Coordinating Center (MBCC) for the rhIGF-1 Genentech Epidemiological Project (IGEP). The IGEP consisted of 6 separate observational epidemiological studies. The studies were selected to provide complementary safety information to clinical trials conducted by Genentech. The trials are designed to determine the efficacy and safety of rhIGF-1 therapy in patients with insulin-dependent diabetes mellitus and non-insulin dependent diabetes mellitus (NIDDM) receiving standard diabetes therapy. Demonstrating safety in clinical trials lasting twelve months with approximately 1,500 patients exposed to rhIGF-1 is limited to the more common events of acute onset. IGEP was designed to provide evidence on the safety of rhIGF-I in the short-term for less common events.
Safety considerations and complications of diabetes with rhIGF-1 treatment differ between IDDM and NIDDM. Hypoglycemia is a more frequent complication of IDDM. Cardiovascular disease, in part because of its association with age, is frequently observed in NIDDM. Microvascular complications, retinopathy, neuropathy and nephropathy, are common to both. Events other than the complications of diabetes may apply jointly to IDDM and NIDDM.
The rhIGF-1 treated cohort was assembled from the randomized controlled trials and their open-label extensions. These consisted of two subcohorts of patients with IDDM and those with NIDDM, treated with either insulin or oral agents. The non- experimental studies within the IGEP utilized the following data bases for reference purposes:
1. Diabetes Control and Complications Trial (DCCT)
2. Epidemiology of Diabetes Interventions and Complications
3. Kaiser Permanente Diabetic Registry
4. Wisconsin Epidemiological Study of Diabetic Retinopathy
5. St. Thomas Hospital Diabetic Registry
6. rhIGF-I Open Label Studies in IDDM and NIDDM
The Biostatistics Center served as the Coordinating Center for the IGEP until the clinical trial was stopped in 1997. Contract funded by Genentech 1997.)