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Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
This study has been completed.

First Received on July 20, 2009.   Last Updated on June 6, 2011   History of Changes
Sponsor: Intarcia Therapeutics
Information provided by: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT00943917
  Purpose

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: ITCA 650
Drug: Exenatide
Drug: exenatide
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • Efficacy of specific doses of ITCA 650 [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2009
Study Completion Date: February 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITCA 650 Drug: ITCA 650
3 month SC implant- various doses
Active Comparator: exenatide Drug: Exenatide
SC injection
Exenatide Injection to ITCA 650 Drug: exenatide
SC injection followed by 3 month implant

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females age 18-70 years
  • Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
  • On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
  • Fasting plasma glucose < 240 mg/dL at Screening Visit 1
  • HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion Criteria:

  • Prior treatment with exenatide
  • Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
  • History of type 1 diabetes and/or history of diabetic ketoacidosis
  • Body mass index ≥ 40 kg/m2;
  • History of organ transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943917

  Show 50 Study Locations
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: VP Clinical Research, Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT00943917     History of Changes
Other Study ID Numbers: ITCA 650-CLP-02
Study First Received: July 20, 2009
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 09, 2012