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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: TT223 with Metformin and/or TZD; Drug: Placebo with Metformin and/or TZD

• Registration Number: NCT00743002
• Lead Sponsor: OPKO Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-28
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2013-06
• Disposition First Submitted: 2013-06-04
• Disposition First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-13
• Disposition First Posted: 2013-06-21
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TT223 with Metformin and/or TZD	TT223 with Metformin and/or TZD	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).
Placebo with Metformin and/or TZD	Placebo with Metformin and/or TZD	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.