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

April 5, 2013 updated by: Intarcia Therapeutics

A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Gardens, Florida, United States, 33169
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Medpace Clinical Pharmacology Unit
    • Texas
      • San Antonio, Texas, United States, 78229
        • DGD Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10 mcg./day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)
Experimental: 20 mcg/day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)
Experimental: 40 mcg/day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)
Experimental: 80 mcg/day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With Study Drug-Related Adverse Events
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Time Frame: 4 weeks
Change in HbA1c from baseline
4 weeks
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
Time Frame: 4 weeks
4 weeks
Change in Weight From Baseline to 4 Weeks
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intarcia Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 22, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCA 650-CLP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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