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:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Exenatide

U.S. FDA Resources

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

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

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