Diabetes Mellitus, Type 2
Conditions
Keywords
TT223
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.
Interventions
DRUGTT223 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
DRUGPlacebo 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
Sponsors
OPKO Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | For the duration of the trial. |
Secondary
| 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. | 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. |
Countries
United States
Outcome results
None listed