Clinical trial NCT00743002: A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled Study of TT223 in Patients With Type 2 Diabetes Treated With Metformin and/or TZD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: TT223
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg.
timeFrame: For the duration of the trial.
Secondary outcomes:
measure: 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.
timeFrame: For the duration of the trial.
measure: To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing.
timeFrame: For the duration of the trial.
measure: To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients.
timeFrame: Day 1 and Week 12 of treatment.
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrence
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Deland
country: United States
state: Florida
city: Bloomingdale
country: United States
state: Illinois
city: Grand Rapids
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Clifton
country: United States
state: New Jersey
city: Asheboro
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Bensalem
country: United States
state: Pennsylvania
city: Athens
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References: