A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes

A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: ITCA 650 60 mcg/day; Drug: sitagliptin

• Study Type: Interventional
• Enrollment (Actual): 535
• Phase: Phase 3

Contacts and Locations

Study Locations

• Croatia
  • Rijeka, Croatia, 51000
• Denmark
  • Hvidovre, Denmark, 2650
• Germany
  • Niedersachsen
    • Bad Lauterberg im Harz, Niedersachsen, Germany, 37431
• Latvia
  • Riga, Latvia, LV1002
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
  • Arizona
    • Chandler, Arizona, United States, 85224
  • California
    • Long Beach, California, United States, 90807
    • Los Angeles, California, United States, 90017
    • San Diego, California, United States, 92101
    • San Mateo, California, United States, 94401
    • Tustin, California, United States, 92780
    • Valley Village, California, United States, 91607
    • Walnut Creek, California, United States, 94598
  • Florida
    • Boca Raton, Florida, United States, 33432
    • Clearwater, Florida, United States, 33765
    • Coral Gables, Florida, United States, 33134
    • Miami, Florida, United States, 33126
    • North Miami Beach, Florida, United States, 33162
    • Pembroke Pines, Florida, United States, 33026
  • Georgia
    • Canton, Georgia, United States, 30114
  • Illinois
    • Chicago, Illinois, United States, 60634
    • Chicago, Illinois, United States, 60607
  • Indiana
    • Avon, Indiana, United States, 46123
    • Franklin, Indiana, United States, 46131
    • Greenfield, Indiana, United States, 46140
    • Muncie, Indiana, United States, 47304
    • Valparaiso, Indiana, United States, 46383
  • Kansas
    • Wichita, Kansas, United States, 67208
    • Wichita, Kansas, United States, 67205
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • Massachusetts
    • Brockton, Massachusetts, United States, 2301
  • Michigan
    • Traverse City, Michigan, United States, 49684
    • Troy, Michigan, United States, 48098
  • Missouri
    • St. Louis, Missouri, United States, 63110
  • Montana
    • Billings, Montana, United States, 59101
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
  • Nevada
    • Las Vegas, Nevada, United States, 89148
  • New York
    • Brooklyn, New York, United States, 11218
    • Endwell, New York, United States, 13760
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Cincinnati, Ohio, United States, 45227
    • Kettering, Ohio, United States, 45429
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
  • Oregon
    • Bend, Oregon, United States, 97701
  • Pennsylvania
    • Uniontown, Pennsylvania, United States, 15401
  • Tennessee
    • Memphis, Tennessee, United States, 38119
  • Texas
    • Corpus Christi, Texas, United States, 78414
    • Dallas, Texas, United States, 75230
    • Dallas, Texas, United States, 75390
    • Houston, Texas, United States, 77083
    • San Antonio, Texas, United States, 78229
    • Sugar Land, Texas, United States, 77478
    • Tomball, Texas, United States, 77375

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HbA1c between 7.5% - 10.5%
• on metformin monotherapy
• BMI between 25 & 45 kg/m2

Exclusion Criteria:

• taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
• history of pancreatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sitagliptin; sitagliptin 100 mg/day	Drug: sitagliptin; oral sitagliptin 100 mg/day
Experimental: ITCA 650 60 mcg/day; ITCA 650 is exenatide in DUROS	Drug: ITCA 650 60 mcg/day; exenatide in DUROS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c between Week 52 and Day 0	52 weeks

Collaborators and Investigators

• Sponsor: Intarcia Therapeutics

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Anti-Obesity Agents; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate; Exenatide
• Other Study ID Numbers: ITCA 650-CLP-105