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Added on August 15, 2012 at 10:01 AM by Lindner, Jill
Modified on February 7, 2017 at 4:27 PM by Ray, Terri
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Study

 

PI

Contact

Accrual

Description

Lilly

T2DM

U500 Insulin

 

Protocol B5K-MC-IBHD

Safety and Efficacy of Human Regular U-500 Insulin

Administered by Continuous Subcutaneous Insulin

Infusion versus Multiple Daily Injections in Subjects with

Type 2 Diabetes Mellitus: A Randomized, Open-Label,

Parallel Clinical Trial

(VIVID: Evaluating U-500R Infusion versus Injection in Type 2 Diabetes Mellitus)

 

Dr. May

Dianne Davis

936-1140

1 enrolled

target 6

The primary objective is to demonstrate the change in glycated hemoglobin A1c (HbA1c) of U-500R administered by CSII is noninferior to U-500R administered by MDI therapy from baseline to the 26-week in high-dose insulinrequiring patients with T2DM who have inadequate glycemic control on high-dose non U-500R (>200 and ≤600 units per day) insulins (CSII or MDI) and/or high-dose U-500R insulin (MDI) without use of GLP-1 receptor agonists or SGLT2 inhibitors and with or without other insulins/AHAs. This population is referred to as Group A.

 

This is a Phase 3b, multicenter, randomized, open-label, parallel clinical trial comparing U-500R

administered by CSII (OmniPod U-500 system) to U-500R administered MDI in high-dose insulin-requiring patients with T2DM who have inadequate glycemic control on high-dose non U-500R (>200 and ≤600 units per day) insulins (CSII or MDI) and/or U-500R insulin (MDI) with or without other insulins/AHAs. The trial design includes a 1-week screening period, a 2-week lead-in period, and a 26-week treatment period (2 week transition to U-500R MDI administered TID, 12 weeks titration, and 12 weeks maintenance U-500R CSII or MDI).

Diagnosis and

BI 1245.69

T1DM

Empagliflozin

 

A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy,

safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive

to inSulin thErapy over 52 weeks in patients with Type 1 Diabetes Mellitus (EASE

Dr. Baum

Janet Fry

936-5886

6 active

1 consented/ screening

 

 target 6-8

 

The objective of this study is to assess the efficacy, safety, tolerability and

pharmacokinetics (PK) of once daily oral doses of empagliflozin 10 mg and 25 mg

in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy

Randomised, double-blind, placebo-controlled parallel group comparison of 2 oral

once daily doses (10 mg and 25 mg) of empagliflozin to placebo. Randomisation

will be stratified by:

  • pre-existing insulin therapy (multiple daily injections [MDI] vs continuous

subcutaneous insulin infusion [CSII])

  • Visit 5 estimated Glomerular filtration rate (eGFR) as calculated by the

Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (<

60 mL/min/1.73 m2 vs ≥ 60 mL/min/1.73 m2)

  • Visit 5 HbA1c (< 8.5% vs ≥ 8.5%)

 

T1DM MRI Study

T1DM New Diagnosis

JDRF funding

 

Development of 3T MRI/MRS Applications for Diabetes Research

Dr. Powers

Jon Williams

875-9200

51 enrolled

target 100

The overall goal of the research proposed is to develop, optimize, and validate novel quantitative magnetic resonance imaging (MRI) of the pancreas as a biomarker for type 1 diabetes mellitus (T1DM).

We hypothesize that the application of advanced quantitative MRI metrics to pancreas imaging will provide a diagnostic biomarker of type 1 diabetes and provide insight into its pathogenesis.

Specific Aim #1. Optimize advanced quantitative MRI for analysis of the human pancreas.

Specific Aim #2. Assess the ability of developed quantitative MRI metrics to detect and distinguish pancreas pathology in type 1 diabetes.

 

Exenatide Inpatient Trial

T2DM AstraZeneca/ Emory

 

Exenatide vs exenatide plus basal insulin vs basal bolus insulin regimen

 

Dr. Eckerle-Mize

Jon Williams

875-9200

 

7 randomized

10 consented

target 50

Hypothesis: Treatment with exenatide alone or in combination with basal insulin will result in a similar glycemic control and in a lower frequency of hypoglycemia than treatment with basal bolus in general non-ICU patients with T2D. 

Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily blood glucose concentration and frequency of hypoglycemic events, is different between treatment with exenatide (Byetta®) alone, exenatide in combination with basal insulin (glargine or detemir),  and basal bolus regimen in general medicine and surgery patients with T2D

Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily blood glucose concentration and frequency of hypoglycemic events, is different between treatment with exenatide (Byetta®) alone, exenatide in combination with basal insulin (glargine or detemir),  and basal bolus regimen in general medicine and surgery patients with T2D

VPI

VPI-2690B

T1DM Monoclonal antibody

 

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center,

Parallel Group, Phase 2, Two-Part Adaptive Study to Evaluate the Safety and Efficacy of VPI-2690B Injection in Patients with

Nephropathy Due to Diabetes

 

Dr. Baum

 Jon Williams

875-9200

1

The primary objective of this study is to evaluate the efficacy of 2 doses of

VPI-2690B Injection, administered once every 2 weeks by subcutaneous

injection, compared to placebo, as assessed by the percent change from

baseline to endpoint in albuminuria (as measured by urinary albumin to

creatinine ratio [UACR] mg/g in first morning void urine samples) in patients

with nephropathy due to diabetes.

 

Cohort A closed to enrollment,Cohort B pending.

 

 

GSK

T2DM Albiglutide

 

A long term, randomised, double-blind, placebo-controlled study

to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus. Harmony Outcomes Trial.

 

Dr.Baum

Dianne Davis

936-1140

3 enrolled

target 10

Primary Objective: To determine whether albiglutide is non-inferior with respect to MACE when added to glycaemic standard of care versus standard of care alone

GRADE

T2DM

-Glimepiride

-Sitagliptin

-Liraglutide

-Insulin

 

The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE Study)

Dr. Elasy

Stephanie Martin

936-1705

65 on study

Target 100

This parallel group, unmasked clinical trial will randomize 5000 consenting subjects with

Eligible participants will be randomly assigned to one of four diabetes medications in combination with metformin. The principal comparisons will be among the four drug groups starting from the time of randomization.

Briefly, the primary outcome is the time to the observation of a HbA1c >7%, subsequently confirmed while receiving the maximally tolerated dose of the assigned regimen (intention-to-treat principle). The secondary outcome is the time to the observation of a HbA1c >7.5%, subsequently confirmed, and the tertiary outcome is defined as the time to another HbA1c >7.5%, confirmed, after treatment with basal insulin, at which time an intensive basal/bolus insulin regimen is initiated. Each of these outcomes is counted while receiving the maximally tolerated dose of the assigned regimen and regardless of adherence to assigned medications at the time of the HbA1c test according to principles of intention-to-treat analysis.

BMS MB102-229

T1DM

Dapagliflozin

 

A Multicenter, Randomized,Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to

Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus

 

Dr. Bao

Cindy Lovell

936-1149

6

Research Hypothesis: After 24 weeks of oral administration of double-blind treatment, the change from baseline in A1C (HbA1c) level with dapagliflozin plus insulin is greater than placebo plus adjustable insulin in subjects with type 1 diabetes who have inadequate glycemic control. In this study, adjustments of insulin dose can be made as deemed appropriate to be consistent with good medical practice.

 

The primary objective of this study is to compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the change from baseline in A1C (HbA1c) after 24 weeks of double-blinded treatment.

 

Closed to enrollment; 6 active

Devote

T2DM

Insulin deludec vs Insulin glargine

 

A trial comparing cardiovascular safety of insulin degludec

versus insulin glargine in subjects with type 2 diabetes at high

risk of cardiovascular events

Dr. May

Dianne Davis

936-1140

15

The primary objective is to confirm the cardiovascular safety of insulin degludec compared to that of insulin glargine.

The secondary objectives are to assess efficacy of insulin degludec on markers of glycaemic control and to assess safety on other parameters in subjects with type 2 diabetes at high risk of cardiovascular events.

 

Closed to enrollment; end of study scheduled June/ July 2016.

 

EDIC

Epidemiology

T1DM

 

Epidemiology of Diabetes Interventions and Complications Continuing Follow-Up

Dr. May

Janie Lipps

936-1149

62

Numerous important clinical research questions remain regarding long-term complications in type 1 diabetes. The DCCT/EDIC cohort, the largest and best characterized group of Type 1 diabetic subjects, is uniquely able to answer many of these clinically important questions.

The clinical research questions that need to be addressed and that the DCCT/EDIC Research Group and Cohort can address include the following:

  1. What are the long(er) term effects of the original interventions on advanced complications that affect health status?
  2. What is the longevity of the metabolic memory phenomenon?
  3. What is the modern-day clinical course of diabetic complications including the interactions among complications and co-progression of complications (triopathy)? Does intensive therapy only delay the development of advanced complications, or are they truly prevented?
  4. What are the pathophysiologic, pathogenetic and inflammatory mechanisms that underlie the development and progression of microvascular and neurologic complications? (refer to EDIC Genetic Studies and EDIC CVD protocols)
  5. What are the long(er)-term effects of intensive vs. conventional therapy on cardiovascular events?
  6. What are the pathophysiologic, pathogenetic and inflammatory mechanisms that underlie the development and progression of cardiovascular disease? (refer to EDIC Genetic Studies and EDIC CVD protocols)
  7. What is the impact of intensive compared with conventional therapy on quality of life?
  8. What are the economic (cost:benefit) implications of intensive therapy in the long-term?

 

C-Peptide- 45 test completed. Hypo/arrhythmia sub-study to launch summer 2016.

 
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