Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

NCT00943917 | Completed Phase 2 Results

• 1 other identifier: ITCA 650-CLP-02
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 50

Brief Summary

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

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (6)

• Mean Change in HbA1c (Per Protocol)

  Mean change in HbA1c over first 12 weeks (Stage I)

  Day 0 and Week 12

• Mean Change in HbA1c (ITT)

  Mean change in HbA1c through Week 12

  Day 0 to Week 12

• Mean Change in HbA1c (Per Protocol)

  Mean change in HbA1c through Week 24

  Day 0 to Week 24

• Mean Change in HbA1c (ITT)

  Mean change in HbA1c through Week 24

  Day 0 to Week 24

• Mean Change in HbA1c (Per Protocol)

  Mean change in HbA1c through Week 48

  Day 0 to Week 48

• Mean Change in HbA1c (ITT)

  Mean change in HbA1c through Week 48

  Day 0 to Week 48

Study Arms (9)

ITCA 650 20 mcg/day

EXPERIMENTAL

Other: ITCA 650

ITCA 650 40 mcg/day

EXPERIMENTAL

Other: ITCA 650

Exenatide Injection

ACTIVE COMPARATOR

Drug: Exenatide Injection

ITCA 650 20/20

EXPERIMENTAL

Other: ITCA 650

ITCA 650 20/60

EXPERIMENTAL

Other: ITCA 650

ITCA 650 40/40

EXPERIMENTAL

Other: ITCA 650

ITCA 650 40/80

EXPERIMENTAL

Other: ITCA 650

Ex Inj/ITCA 650 40

EXPERIMENTAL

Other: Ex Inj/ITCA 650

Ex Inj/ITCA 650 60

EXPERIMENTAL

Other: Ex Inj/ITCA 650

Interventions

ITCA 650 OTHER

ITCA 650 (continuous delivery of exenatide in DUROS)

ITCA 650 20 mcg/day; ITCA 650 20/20; ITCA 650 20/60; ITCA 650 40 mcg/day; ITCA 650 40/40; ITCA 650 40/80

Exenatide Injection DRUG

twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks

Also known as: Byetta

Exenatide Injection

Ex Inj/ITCA 650 OTHER

twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650

Also known as: Byetta

Ex Inj/ITCA 650 40; Ex Inj/ITCA 650 60

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (50)

Study Site

Chino, California, 91710, United States

Location

Study Site

La Jolla, California, 92037, United States

Location

Study Site

National City, California, 91950, United States

Location

Study Site

Sacramento, California, 95821, United States

Location

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San Diego, California, 92161, United States

Location

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Valley Village, California, 91607, United States

Location

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Longmont, Colorado, 80501, United States

Location

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Pueblo, Colorado, 81001, United States

Location

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Bradenton, Florida, 34203, United States

Location

Study Site

Miami, Florida, 33143, United States

Location

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Miami, Florida, 33169, United States

Location

Study Site

Miami, Florida, 33183, United States

Location

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Miramar, Florida, 33025, United States

Location

Study Site

Pembroke Pines, Florida, 33026, United States

Location

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St. Petersburg, Florida, 33709, United States

Location

Study Site

Atlanta, Georgia, 30342, United States

Location

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Sandy Springs, Georgia, 30328, United States

Location

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Meridian, Idaho, 83642, United States

Location

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Chicago, Illinois, 60607, United States

Location

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Avon, Indiana, 46123, United States

Location

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Wichita, Kansas, 67205, United States

Location

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Lexington, Kentucky, 40503, United States

Location

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New Orleans, Louisiana, 70112, United States

Location

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Kalamazoo, Michigan, 49007, United States

Location

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Traverse City, Michigan, 49684, United States

Location

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Troy, Michigan, 48098, United States

Location

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Ypsilanti, Michigan, 48197, United States

Location

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Minneapolis, Minnesota, 55416, United States

Location

Study Site

Las Vegas, Nevada, 89119, United States

Location

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New Hyde Park, New York, 11042, United States

Location

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Charlotte, North Carolina, 28209, United States

Location

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Hickory, North Carolina, 28601, United States

Location

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Cincinnati, Ohio, 45212, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

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Franklin, Ohio, 45005, United States

Location

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Kettering, Ohio, 45429, United States

Location

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Norman, Oklahoma, 73069, United States

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Eugene, Oregon, 97404, United States

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Rapid City, South Dakota, 57702, United States

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Austin, Texas, 78749, United States

Location

Study Site

Austin, Texas, 78752, United States

Location

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Dallas, Texas, 75230, United States

Location

Study Site

Dallas, Texas, 75251, United States

Location

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Irving, Texas, 75039, United States

Location

Study Site

San Antonio, Texas, 78205, United States

Location

Study Site

San Antonio, Texas, 78229, United States

Location

Study Site

West Jordan, Utah, 84088, United States

Location

Study Site

Norfolk, Virginia, 23502, United States

Location

Study Site

Olympia, Washington, 98502, United States

Location

Study Site

Spokane, Washington, 99202, United States

Location

Related Publications (1)

• Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2559-65. doi: 10.2337/dc12-2410. Epub 2013 May 3.

  PMID: 23645886 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Limitations and Caveats

8 subjects (4 in 20, 1 in 40 and 3 in ex inj)completed StI but not randomized to St II; 3 subjects (2 in 20/20 \& 1 in 40/80) who completed St I, randomized to St II but not given study drug. St II Cont was optional, so not all pts elected to continue

Results Point of Contact

• Title: Michelle Baron MD
• Organization: Intarcia Therapeutics, Inc

clinicaltrials@intarcia.com

510-782-7800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: February 1, 2011
• Last Updated: April 13, 2015
• Results First Posted: May 3, 2012

Record last verified: 2015-03

Locations

US (50)