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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment87
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00743002A Trial of TT223 in Patients With Type 2 Diabetes Who Are Taking Metformin and/or ThiazolidinedionePHASE2 COMPLETED 87Aug 1, 2008Dec 1, 2009Jun 21, 201320 United States
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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 — 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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