Completed

ITCA 650 Safety and Tolerability in Type 2 Diabetes Mellitus

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Study Aim

This phase 1 study aims to evaluate the safety and tolerability of ITCA 650 in individuals with Type 2 Diabetes Mellitus, primarily focusing on the number of participants experiencing drug-related adverse events.

What is being tested

ITCA 650 (exenatide in DUROS)

+ ITCA 650 (exenatide in DUROS)

+ ITCA 650 (exenatide in DUROS)

Drug
Who is being recruted

Diabetes Mellitus+3

+ Endocrine System Diseases

+ Metabolic Diseases

From 30 to 70 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2009
See protocol details

Summary

Principal SponsorIntarcia Therapeutics
Last updated: May 17, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2009

Actual date on which the first participant was enrolled.

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

NCT01798264
Principal SponsorIntarcia Therapeutics
Last updated: May 17, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 2

Criteria

2 inclusion criteria required to participate
stable diet & exercise, metformin, TZD or met + TZD HbA1c > 6.5% < 10.0%
type 2 diabetes > 6 months
3 exclusion criteria prevent from participating
history of medullary thyroid cancer or multiple endocrine neoplasia 2
history of pancreatitis
prior treatment with exenatide

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
ITCA 650 (exenatide in DUROS)

Group II

Experimental
ITCA 650 (exenatide in DUROS)

Group III

Experimental
ITCA 650 (exenatide in DUROS)

Group IV

Experimental
ITCA 650 (exenatide in DUROS)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Miami Gardens, United StatesOpen in Google Maps

Medpace Clinical Pharmacology Unit

Cincinnati, United States

dGd Research

San Antonio, United States
Completed3 Study Centers