Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

Phase 1CompletedNCT01798264

Intarcia Therapeutics44 enrolled

Overview

evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

ITCA 650 (exenatide in DUROS)DRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * type 2 diabetes \>6 months * stable diet \& exercise, metformin, TZD or met + TZD HbA1c \>6.5% \<10.0% Exclusion Criteria: * prior treatment with exenatide * history of pancreatitis * history of medullary thyroid cancer or multiple endocrine neoplasia 2

Locations (3)

Unnamed facility

Miami Gardens, Florida, United States

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States

dGd Research

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Number of Subjects With Study Drug-Related Adverse Events

Time frame: 4 weeks

Secondary Outcomes

To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Change in HbA1c from baseline

Time frame: 4 weeks

Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline

Time frame: 4 weeks

Change in Weight From Baseline to 4 Weeks

Time frame: 4 weeks

Data from ClinicalTrials.gov

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