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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743002
• Other study ID #: GIN-201
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2008
• Last updated: June 13, 2013
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2013
• Source: Transition Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• TT223 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
• Placebo 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Transition Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No
Secondary	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.	No
Secondary	To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients.		Day 1 and Week 12 of treatment.	No