CURRENT STUDIES
Type 1 - F3Z-MC-IOPV [ Show Detaile ]This is a 26 weeks, comparing Humalog to Novolog in pump over 6 days of pump reservoir in-use. Additionally, compares Humalog 6 day use with Humalog 2 day use. Inclusion criteria: T1DM >24mo, age >13yo, pump >6mo, use <46U/day in 300U reservoir or <26U/day in 180U reservoir, BMI <35.0, A1c 5%-9%. Exclusion: CGM unless agrees to not use in study, impaired renal function, hypo coma or seizures last 12mo, hypo unawareness, ER visit last 12mo, many pump occlusions, staph infection past 5y, hemoglobin abnormality, glucocorticoid therapy, irregular sleep cycle, need 10-20 people.
Contact:
Christie Beatson – Christie.Beatson@ucdenver.edu[ Hide Detail ] 35-46 day Randomized, cross-over study of the low glucose suspend (LGS) feature in the MiniMed Paradigm X54 system. Suspends from hypoglycemic episodes due to exercise. Pts will go low by exercising at BDC. 50 patients between 8 sites. Inclusion: 16-60yo, >45kg, T1DM >12mo, use a Medtronic pump last 3mo, A1c 7%-10%, ability to exercise for extended period of time, T1DM >20y. Excl.: hypo coma or seizure in last 3y, adverse skin reaction at site, heart condition, CVA, Graves disease, renal impairment, abnormal hematocrit, K, TSH, fT4; hx of smoking >5y, betablockers, steroids last 30d.
Contact:
Mary.Voelmle@ucdenver.edu[ Hide Detail ] SIBA is Novo’s new, long acting insulin to rival Lantus,“Soluble Insulin Basal Analogue.” TIDM, 52 week trial comparing SIBA to Lantus, both with Humalog. 20 in-clinic visits, 22 phone contacts. A1c <10%, BMI <35, 34 screened, 31 enrolled. Ends Sept. 2010, extension study coming.
Contact:
Christie Beatson – Christie.Beatson@ucdenver.edu[ Hide Detail ] 29 wEek trial comparing SIBA to Lantus both using insulin aspart. Randomized to either: 1.) Insulin glargine QD, 2.) SIBA QD, or 3.) SIBA fixed flexible schedule. 15 in-clinic visits, 14 phone contacts. A1c <10%, BMI <35. Expect 30-40 patients. Ends Sept., 2010, extension likely.
Contact:
Christie Beatson – Christie.Beatson@ucdenver.edu[ Hide Detail ] UPCOMING STUDIES
Type 1 – 2nd Januvia Study, MRK-SI-100 [ Show Detail ]Because our first Januvia Inv. Initiated study was positive, Merck is paying us to initiate a larger, 140 pt, 6 month Investigator initiated multi-center trial! This is a double-blind randomized study with 6 visits with 3 meal challenges and 4 weeks of DexCom wear over 6 months. 100 mg Januvia once daily, A1c 7.5-10%, BMI ≤ 35, injections or pump ok, 25ish screened, done end of Jan.
Contact:
Christie Beatson – Christie.Beatson@ucdenver.edu[ Hide Detail ] A 6 month, phase 2 crossover trial: PH20/Hyalouronidase is an approved substance that decreases interstitial viscosity so injected insulin disperses faster and thus acts faster. A1c 6.7 to 8.2, pump or injection ok, switch to BID lantus. 30 weeks, 12 weeks on Humalog and 12 weeks on either PH20+Humalog or PH20+Novolog.
Contact:
Christie Beatson – Christie.Beatson@ucdenver.edu[ Hide Detail ] A 6 month, phase 2 crossover trial just Like HALO-205 except in T2DM instead of T1. No pramlitide, exenatide, liraglutide sulfonureas for 1-2 months. A1c 7 to 8.5, switch to BID lantus. 30 weeks, 12 weeks on Humalog and 12 weeks on either PH20+Humalog or PH20+Novolog crossed over.
Contact:
Christie Beatson – Christie.Beatson@ucdenver.edu[ Hide Detail ] Eli Lilly investigational long acting insulin for T2D. New insulin is injected once weekly. Noninferiority study to latus in glycemic control. Approximately 52 week parallel open label study. A1c >7% on insulin injections for less than 10 years
Contact:
Christie Beatson – Christie.Beatson@ucdenver.edu[ Hide Detail ]