A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione

June 13, 2013 updated by: OPKO Health, Inc.

A Multi-center, Double-blind, Randomized, Placebo-controlled Study of TT223 in Patients With Type 2 Diabetes Treated With Metformin and/or TZD

This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

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
    • California
      • Artesia, California, United States
      • Los Angeles, California, United States
      • Santa Ana, California, United States
      • Torrence, California, United States
      • Walnut Creek, California, United States
    • Florida
      • Deland, Florida, United States
    • Illinois
      • Bloomingdale, Illinois, United States
    • Michigan
      • Grand Rapids, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Clifton, New Jersey, United States
    • North Carolina
      • Asheboro, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Pennsylvania
      • Bensalem, Pennsylvania, United States
    • Tennessee
      • Athens, Tennessee, United States
    • Texas
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Richmond, Texas, United States
      • San Antonio, Texas, United States

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes for at least 6 months
  • Treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
  • BMI of 21-45 kg/m2, inclusive
  • HbA1c level of 7.50 - 10.00%, inclusive
  • If a female of childbearing potential, willing to utilize contraception from Screening through 4 weeks after the last dose of study drug

Exclusion Criteria:

  • Treatment with insulin, sulfonylurea, DPP-4 inhibitors, Symlin® and/or GLP-1 analogues ≤ 3 months prior to the Screening
  • Severe hypoglycemia ≤ 60 days prior to the Screening visit or currently diagnosed with having hypoglycemia unawareness
  • History of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
  • Previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
  • Myocardial infarction within the last 2 years, current congestive heart failure with NYHA class 2 or greater, or chronic atrial fibrillation
  • Current clinically significant and/or chronic illness
  • Takes regular courses of non-steroidal anti-inflammatory drugs (NSAIDS). If these medications are discontinued upon starting Screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the Study
  • Use of systemic corticosteroids (oral, suppository, injected). Use of inhaled or topical corticosteroids is permitted

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TT223 with Metformin and/or TZD
TT223 as a treatment for Type 2 diabetes is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD).
Drug: TT223 with Metformin and/or TZD
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
PLACEBO_COMPARATOR: Placebo with Metformin and/or TZD
Placebo as a comparator is administered by injection once daily at 1 mg, 2 mg and 3 mg patients currently treated with Metformin and/or Thiazolidinedione (TZD).
Drug: Placebo with Metformin and/or TZD
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg.
Time Frame: For the duration of the trial.
For the duration of the trial.

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the efficacy of TT223 as a treatment for Type 2 diabetes by comparing the change in HbA1c value from baseline between the TT223 and placebo groups.
Time Frame: For the duration of the trial.
For the duration of the trial.
To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing.
Time Frame: For the duration of the trial.
For the duration of the trial.
To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients.
Time Frame: Day 1 and Week 12 of treatment.
Day 1 and Week 12 of treatment.

Collaborators and Investigators

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

Sponsor

OPKO Health, Inc.

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

August 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (ESTIMATE)

August 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIN-201

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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