A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Study Site, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HbA1c between 7.5% - 10%
On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
BMI between 25 & 45 kg/m2

Exclusion criteria

taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
history of pancreatitis

Treatment and study plan

ITCA 650

Drug

ITCA 650 is exenatide in DUROS

ITCA placebo

Other

Formulation in DUROS (no exenatide)

Primary outcomes

Change in HbA1c

Time frame: 39 weeks

39-week Treatment Period

Sponsors and collaborators

Lead sponsor

Intarcia Therapeutics

Industry

Registry information

Official study title

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Oct 20, 2011
Registry last updated: Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed