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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: TT223 with Metformin and/or TZD
* Drug: Placebo with Metformin and/or TZD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TT223 with Metformin and/or TZD<br>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<br>* Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks<br>|
| Placebo Comparator: Placebo with Metformin and/or TZD<br>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<br>* Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TT223