Abstract

This is a phase II, multicenter, active controlled 1:1:1 randomized 4-week parallel group study with 3 treatment groups (HOE901(30); HOE901(80); and NPH-human insulin. Primary objectives include (1) investigating the safety and tolerability of HOE901(30) and HOE901(80) in comparison to NPH insulin in insulin-dependent diabetes mellitus (IDDM) patients; (2) selecting a formulation to be investigated in phase III clinical trials; and (3) comparing the efficacy of HOE901 and NPH with regard to fasting glucose in IDDM patients.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000069-35
Application #
6246119
Study Section
Project Start
1997-03-20
Project End
1997-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
35
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
University of Colorado Denver
Department
Type
DUNS #
065391526
City
Aurora
State
CO
Country
United States
Zip Code
80045

  Publications

Young, Kendra A; Maturu, Amita; Lorenzo, Carlos et al. (2018) The triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio as a predictor of insulin resistance, ?-cell function, and diabetes in Hispanics and African Americans. J Diabetes Complications :
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Jacobson, Denise L; Lindsey, Jane C; Coull, Brent A et al. (2018) The Association of Fat and Lean Tissue With Whole Body and Spine Bone Mineral Density Is Modified by HIV Status and Sex in Children and Youth. Pediatr Infect Dis J 37:71-77
Levenson, Amy E; Wadwa, R Paul; Shah, Amy S et al. (2017) PCSK9 Is Increased in Youth With Type 1 Diabetes. Diabetes Care 40:e85-e87

Showing the most recent 10 out of 837 publications