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Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798264
Recruitment Status : Completed
First Posted : February 25, 2013
Results First Posted : May 17, 2013
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics

Brief Summary:
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: ITCA 650 (exenatide in DUROS) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Study Start Date : February 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: 10 mcg./day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)
Experimental: 20 mcg/day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)
Experimental: 40 mcg/day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)
Experimental: 80 mcg/day
ITCA 650 (exenatide in DUROS)
Drug: ITCA 650 (exenatide in DUROS)



Primary Outcome Measures :
  1. Number of Subjects With Study Drug-Related Adverse Events [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus [ Time Frame: 4 weeks ]
    Change in HbA1c from baseline

  2. Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline [ Time Frame: 4 weeks ]
  3. Change in Weight From Baseline to 4 Weeks [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes >6 months
  • stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%

Exclusion Criteria:

  • prior treatment with exenatide
  • history of pancreatitis
  • history of medullary thyroid cancer or multiple endocrine neoplasia 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798264


Locations
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United States, Florida
Miami Gardens, Florida, United States, 33169
United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45212
United States, Texas
dGd Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Intarcia Therapeutics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01798264    
Other Study ID Numbers: ITCA 650-CLP-01
First Posted: February 25, 2013    Key Record Dates
Results First Posted: May 17, 2013
Last Update Posted: May 17, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists