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

OPKO Health

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo with Metformin and/or TZD; Drug: TT223 with Metformin and/or TZD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743002

GIN-201

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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87 participants in 2 patient groups, including a placebo group

TT223 with Metformin and/or TZD

Experimental group

Description:

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).

Treatment:

Drug: TT223 with Metformin and/or TZD

Placebo with Metformin and/or TZD

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo with Metformin and/or TZD