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ABT-614

Phase 1

Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine | Small molecule | Metabolic |Abbott Laboratories|Trials Updated: Aug 22, 2012

ABT-614 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Nov 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

ABT-614 clinical trials

ABT-614 · 1 trial · 1 indication

Phase 1 1
NCT01464320A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
COMPLETED16 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.
Type 2 Diabetics, Chronic Kidney Disease, Protein in UrineUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in drug concentration
Day -1 (Baseline) and up to Day 15

Blood and urine tests

Change in glomerular filtration rate
Day -1 (Baseline) and up to Day 15

Blood and urine tests

Secondary Endpoints

Change in urinary albumin excretion
Day -1 (Baseline) and up to Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-614EXPERIMENTAL -
Placebo ComparatorPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ABT-614DRUGActive
Placebo ComparatorDRUGPlacebo
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Eligibility Criteria

Age Range19 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria 1. Male or female aged between 19 and 70 years, inclusive, at time of consent. 2. Type 2 diabetes receiving at least one anti-diabetic medication for at least one year at the time of Screening. 3. Hemoglobin A1c \< 12% at the time of Screening. 4. Estimated glomerular filtration ...

Countries:United States
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Frequently asked questions about ABT-614

What is ABT-614?

ABT-614 is an investigational small molecule developed by Abbott Laboratories. It was studied in a Phase 1 clinical trial in adults with type 2 diabetes, chronic kidney disease, and protein in their urine. The trial evaluated its safety and tolerability and its effect on kidney function. It is not an approved medicine.

What is ABT-614 used for in type 2 diabetes and chronic kidney disease?

ABT-614 was studied in a Phase 1 trial in adults with type 2 diabetes and chronic kidney disease who had protein in their urine. The trial assessed the drug's safety and tolerability and its effect on kidney function. It is investigational and has no approved use.

Who makes ABT-614?

ABT-614 is developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. Abbott sponsored the Phase 1 study of the drug in patients with type 2 diabetes and chronic kidney disease with protein in their urine.

What phase is ABT-614 in?

ABT-614 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 16 participants. ABT-614 is investigational and has not been approved by the FDA for any indication.

What clinical trials is ABT-614 in?

ABT-614 has been studied in one completed Phase 1 trial, NCT01464320, titled a study to evaluate the safety and tolerability of ABT-614 and its effect on kidney function in subjects with type 2 diabetes and chronic kidney disease with protein in their urine. It was randomized, double-blind, placebo-controlled, and enrolled 16 participants in the United States.