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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Transition Therapeutics
ClinicalTrials.gov Identifier:
NCT00743002
First received: August 26, 2008
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: TT223 with Metformin and/or TZD
Drug: Placebo with Metformin and/or TZD
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Transition Therapeutics:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg. [ Time Frame: For the duration of the trial. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: For the duration of the trial. ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing. [ Time Frame: For the duration of the trial. ] [ Designated as safety issue: No ]
  • To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients. [ Time Frame: Day 1 and Week 12 of treatment. ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
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 Comparator: 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).
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743002

Locations
United States, California
Artesia, California, United States
Los Angeles, California, United States
Santa Ana, California, United States
Torrence, California, United States
Walnut Creek, California, United States
United States, Florida
Deland, Florida, United States
United States, Illinois
Bloomingdale, Illinois, United States
United States, Michigan
Grand Rapids, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Clifton, New Jersey, United States
United States, North Carolina
Asheboro, North Carolina, United States
Wilmington, North Carolina, United States
United States, Pennsylvania
Bensalem, Pennsylvania, United States
United States, Tennessee
Athens, Tennessee, United States
United States, Texas
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Texas, United States
San Antonio, Texas, United States
Sponsors and Collaborators
Transition Therapeutics
  More Information

No publications provided

Responsible Party: Transition Therapeutics
ClinicalTrials.gov Identifier: NCT00743002     History of Changes
Other Study ID Numbers: GIN-201
Study First Received: August 26, 2008
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Transition Therapeutics:
TT223

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2,4-thiazolidinedione
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014