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TT223 with Metformin and/or TZD

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Opko Health Inc.|Last Updated: Jun 21, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment87

FDA Designations

No designations recorded

Clinical trial landscape

TT223 with Metformin and/or TZD · 1 trial · 1 indication

Phase 2 1
NCT00743002A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or ThiazolidinedioneDiabetes Mellitus, Type 2
COMPLETED87 Analytics
PHASE2COMPLETED
A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or Thiazolidinedione
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TT223 with Metformin and/or TZDEXPERIMENTALTT223 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 TZDPLACEBO_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

NameTypeDescription
TT223 with Metformin and/or TZDDRUGDaily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Placebo with Metformin and/or TZDDRUGDaily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

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 f...

Countries:United States
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Frequently asked questions about TT223 with Metformin and/or TZD

What is TT223 used for in Type 2 Diabetes?

TT223 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is intended for use in patients who are already taking metformin and/or thiazolidinedione (TZD) medications. The drug is currently in Phase 2 clinical development and is not yet approved.

Who makes TT223?

TT223 is being developed by Opko Health Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol OPK. The company is conducting clinical trials to evaluate the safety and efficacy of TT223 in patients with Type 2 Diabetes.

What phase is TT223 in?

TT223 is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is TT223 in?

TT223 has been studied in one completed clinical trial with the identifier NCT00743002. This Phase 2 trial enrolled 87 participants with Type 2 Diabetes who were taking metformin and/or thiazolidinedione. The study was conducted in the United States and included adults aged 18 years and older.

Is TT223 the same as other diabetes drugs?

TT223 is a distinct investigational drug developed by Opko Health Inc. It is not known to be the same as any other marketed diabetes medication. It is being studied specifically as an add-on therapy to metformin and/or thiazolidinediones for patients with Type 2 Diabetes.