Effects of Sitagliptin (Januvia®) on Blood Glucose Control in Patients With Type 1 Diabetes
This is a multi-center, prospective, randomized, double-blind, parallel, placebo controlled clinical trial evaluating the efficacy of sitagliptin in suppressing glucagon release in subjects with type 1 diabetes over a 16 week treatment period. The hypothesis of this study is that sitagliptin (Januvia™) will decrease post-prandial glucagon release and may result in improved glucose control in adult patients with type 1 diabetes. There is only one small, pilot study of sitagliptin in patients with type 1 diabetes which significantly reduced total daily insulin dose and A1c values while improving mean blood glucose (MBG) and time spent in euglycemic range (1). In the pilot study, GLP-1 and glucagon levels were not assessed. The purpose of this trial is to determine if sitagliptin can suppress the paradoxical rise of glucagon, and thus can decrease A1c.
This study will enroll a maximum of 140 patients (with an expected 10% dropout rate) with A1c values between 7.5-10% who will be randomized in a 1:1 fashion to either the study drug or placebo. 100 of these patients will wear a continuous glucose monitor. Subjects may be using insulin via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). The clinic visits will be conducted at screening, -1 week, baseline/randomization, 4 weeks, 12 weeks, and 16 weeks in addition to telephone visits (Appendix 1 and 2). At home, starting at week 0 (randomization/baseline), subjects will take 100 mg/day of sitagliptin or placebo and continue for the study duration. Laboratory analysis will be performed at various time points assessing glucagon, A1c, C-peptide, glucagon-like-peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), and insulin levels.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Effects of Sitagliptin (Januvia®) on Blood Glucose Control in Patients With Type 1 Diabetes and CGM Substudy of the Investigator Initiated Study Protocol Effects of Sitagliptin (Januvia) on Glucagon Suppression and GLP-1 Levels in Patients With Type 1 Diabetes; CGM Substudy|
- To demonstrate a decrease in post-prandial glucagon release as assessed by glucagon area under the curve (AUC) for 3 hours during 4 hour meal tolerance tests [ Time Frame: Primary outcome meausre will be recoreded after 16 weeks of treatment ] [ Designated as safety issue: Yes ]To demonstrate a decrease in post-prandial glucagon release as assessed by glucagon area under the curve (AUC) for 3 hours during 4 hour meal tolerance tests
- Secondary objectives: 1. To demonstrate a 0.3% decrease in A1c in patients with type 1 diabetes after 16 weeks of treatment with sitagliptin. 2. To evaluate changes in total, basal and bolus insulin dose while on sitagliptin. [ Time Frame: Secondary outcome meausre will be recoreded after 16 weeks of treatment ] [ Designated as safety issue: Yes ]
- To demonstrate a 0.3% decrease in A1c in patients with type 1 diabetes after 16 weeks of treatment with sitagliptin.
- To evaluate changes in total, basal and bolus insulin dose while on sitagliptin.
|Study Start Date:||November 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
pill/tablet form of 100mg each. will take one tablet a day throughout study
|Placebo Comparator: Sugar Pill||
Drug: Sugar Pill
100mg tablet once a day
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227460
|United States, Colorado|
|University of Colorado/Barbara Davis Center for Diabetes|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Satish K Garg, MD||University of Colorado Denver, Barbara Davis Center|