A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
A Multi-center, Double-blind, Randomized, Placebo-controlled Study of TT223 in Patients With Type 2 Diabetes Treated With Metformin and/or TZD
1 other identifier
interventional
87
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Aug 2008
Typical duration for phase_2 diabetes-mellitus-type-2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 26, 2008
CompletedFirst Posted
Study publicly available on registry
August 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 21, 2013
June 1, 2013
1.3 years
August 26, 2008
June 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg.
For the duration of the trial.
Secondary Outcomes (3)
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.
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.
For the duration of the trial.
To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients.
Day 1 and Week 12 of treatment.
Study Arms (2)
TT223 with Metformin and/or TZD
EXPERIMENTALTT223 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).
Placebo with Metformin and/or TZD
PLACEBO COMPARATORPlacebo 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).
Interventions
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Artesia, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Torrence, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Bloomingdale, Illinois, United States
Unknown Facility
Grand Rapids, Michigan, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Clifton, New Jersey, United States
Unknown Facility
Asheboro, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Bensalem, Pennsylvania, United States
Unknown Facility
Athens, Tennessee, United States
Unknown Facility
Corpus Christi, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Richmond, Texas, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2008
First Posted
August 28, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 21, 2013
Record last verified: 2013-06