Type 2 DiabetesPhase 2NCT00943917

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

A Phase 2 study testing ITCA 650, Exenatide Injection and Ex Inj/ITCA 650 in people with Type 2 Diabetes, run by Intarcia Therapeutics at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: ITCA 650, Exenatide Injection and Ex Inj/ITCA 650
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 155 participants
Where: 50 sitesUnited States
Study dates: Aug 2009to Feb 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

United States50 sites

Study Site
Atlanta, Georgia, 30342
Study Site
Austin, Texas, 78749
Study Site
Austin, Texas, 78752
Study Site
Avon, Indiana, 46123
Study Site
Bradenton, Florida, 34203
Study Site
Charlotte, North Carolina, 28209
Study Site
Chicago, Illinois, 60607
Study Site
Chino, California, 91710
Study Site
Cincinnati, Ohio, 45212
Study Site
Cincinnati, Ohio, 45219
Study Site
Dallas, Texas, 75230
Study Site
Dallas, Texas, 75251
Study Site
Eugene, Oregon, 97404
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Franklin, Ohio, 45005
Study Site
Hickory, North Carolina, 28601
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Irving, Texas, 75039
Study Site
Kalamazoo, Michigan, 49007
Study Site
Kettering, Ohio, 45429
Study Site
La Jolla, California, 92037
Study Site
Las Vegas, Nevada, 89119
Study Site
Lexington, Kentucky, 40503
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Longmont, Colorado, 80501
Study Site
Meridian, Idaho, 83642
Study Site
Miami, Florida, 33143
Study Site
Miami, Florida, 33169
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Miami, Florida, 33183
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Minneapolis, Minnesota, 55416
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Miramar, Florida, 33025
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National City, California, 91950
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New Hyde Park, New York, 11042
Study Site
New Orleans, Louisiana, 70112
Study Site
Norfolk, Virginia, 23502
Study Site
Norman, Oklahoma, 73069
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Olympia, Washington, 98502
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Pembroke Pines, Florida, 33026
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Pueblo, Colorado, 81001
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Rapid City, South Dakota, 57702
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Sacramento, California, 95821
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San Antonio, Texas, 78205
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San Antonio, Texas, 78229
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San Diego, California, 92161
Study Site
Sandy Springs, Georgia, 30328
Study Site
Spokane, Washington, 99202
Study Site
St. Petersburg, Florida, 33709
Study Site
Traverse City, Michigan, 49684
Study Site
Troy, Michigan, 48098
Study Site
Valley Village, California, 91607
Study Site
West Jordan, Utah, 84088
Study Site
Wichita, Kansas, 67205
Study Site
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

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
Being tested: ITCA 650, Exenatide Injection, Ex Inj/ITCA 650
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ITCA 650Other
ITCA 650 (continuous delivery of exenatide in DUROS)
Exenatide InjectionDrug
Also called Byetta
twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
Ex Inj/ITCA 650Other
Also called Byetta
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650

Study groups in NCT00943917
Study group	Role	What they receive
ITCA 650 20 mcg/day	Experimental	Not described Receives: Other: ITCA 650
ITCA 650 40 mcg/day	Experimental	Not described Receives: Other: ITCA 650
Exenatide Injection	Active comparator	Not described Receives: Drug: Exenatide Injection
ITCA 650 20/20	Experimental	Not described Receives: Other: ITCA 650
ITCA 650 20/60	Experimental	Not described Receives: Other: ITCA 650
ITCA 650 40/40	Experimental	Not described Receives: Other: ITCA 650
ITCA 650 40/80	Experimental	Not described Receives: Other: ITCA 650
Ex Inj/ITCA 650 40	Experimental	Not described Receives: Other: Ex Inj/ITCA 650
Ex Inj/ITCA 650 60	Experimental	Not described Receives: Other: Ex Inj/ITCA 650

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c over first 12 weeks (Stage I)
Measured: Day 0 and Week 12
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 12
Measured: Day 0 to Week 12
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 24
Measured: Day 0 to Week 24
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 24
Measured: Day 0 to Week 24
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 48
Measured: Day 0 to Week 48
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 48
Measured: Day 0 to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Feb 2011

First posted22 Jul 2009 (estimated)
Study startAug 2009
Primary completionAug 2010
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 155 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00943917
Sponsor's protocol ID: ITCA 650-CLP-02
Status last verified: Mar 2015
First submitted: 20 Jul 2009
Last updated: 13 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23645886

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00943917
Acronym / sponsor ID: ITCA 650-CLP-02
Conditions: Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 155 participants (actual)
Lead sponsor: Intarcia TherapeuticsIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Aug 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 22 Jul 2009 (estimated)
Results: Posted 3 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ITCA 650ITCA 650 (continuous delivery of exenatide in DUROS)	Other	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 InjectionAlso: Byettatwice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks	Drug	Exenatide Injection
Ex Inj/ITCA 650Also: Byettatwice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650	Other	Ex Inj/ITCA 650 40, Ex Inj/ITCA 650 60

Primary outcome

Mean Change in HbA1c (Per Protocol)
Time frame: Day 0 and Week 12
Mean change in HbA1c over first 12 weeks (Stage I)
Mean Change in HbA1c (ITT)
Time frame: Day 0 to Week 12
Mean change in HbA1c through Week 12
Mean Change in HbA1c (Per Protocol)
Time frame: Day 0 to Week 24
Mean change in HbA1c through Week 24
Mean Change in HbA1c (ITT)
Time frame: Day 0 to Week 24
Mean change in HbA1c through Week 24
Mean Change in HbA1c (Per Protocol)
Time frame: Day 0 to Week 48
Mean change in HbA1c through Week 48
Mean Change in HbA1c (ITT)
Time frame: Day 0 to Week 48
Mean change in HbA1c through Week 48

Results and safety

Results posted to the registry on 3 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ITCA 650 20 mcg/Day- STAGE I	51	47
ITCA 650 40 mcg/Day- STAGE I	51	48
Exenatide Injection- STAGE I	53	47
ITCA 650 20/20- STAGE II	0	0
ITCA 650 20/60- STAGE II	0	0
ITCA 650 40/40 - STAGE II	0	0
ITCA 650 40/80 - STAGE II	0	0
Ex Inj/ITCA 650 40 mcg/Day- STAGE II	0	0
Ex Inj/ITCA 650 60 mcg/Day- STAGE II	0	0
ITCA 650 20/20 Continuation	0	0
ITCA 650 20/40 Continuation	0	0
ITCA 650 40/40 Contination	0	0
ITCA 650 40/80 Continuation	0	0
Ex Inj/ITCA 650 40 Continuation	0	0
Ex Inj/ITCA 650 60 Continuation	0	0

Primary outcome: Mean Change in HbA1c (Per Protocol)

Time frame: Day 0 and Week 12. Mean (Standard Deviation). Unit: percent change

Measure	ITCA 650 20 mcg/Day - STAGE I n = 47	ITCA 650 40 mcg/Day - STAGE I n = 45	Exenatide Injection - STAGE I n = 47
Value	-0.96 (0.905)	-1.04 (0.713)	-0.82 (0.870)

Population analysed: Per protocol analysis- Only subjects with values at baseline and Week 12 endpoint are included.

Primary outcome: Mean Change in HbA1c (ITT)

Time frame: Day 0 to Week 12. Mean (Standard Deviation). Unit: percent change

Measure	ITCA 650 20 mcg/Day - STAGE I n = 51	ITCA 650 40 mcg/Day - STAGE I n = 51	Exenatide Injection - STAGE I n = 52
Value	-.93 (0.882)	-0.96 (0.724)	-0.75 (0.866)

Population analysed: Intent to treat analysis

Primary outcome: Mean Change in HbA1c (Per Protocol)

Time frame: Day 0 to Week 24. Mean (Standard Deviation). Unit: percent change

Measure	ITCA 650 20/20 n = 20	ITCA 650 20/60 n = 21	ITCA 650 40/40 n = 19	ITCA 650 40/80 n = 19	Ex Inj/ITCA 650 40 n = 22	Ex Inj/ITCA 650 60 n = 20
Value	-.89 (.660)	-1.26 (.950)	-0.67 (.908)	-1.36 (0.664)	-1.01 (0.823)	-1.51 (1.266)

Population analysed: Per protocol analysis - Only subjects with values at baseline and Week 24 endpoint are included.

Primary outcome: Mean Change in HbA1c (ITT)

Time frame: Day 0 to Week 24. Mean (Standard Deviation). Unit: percent change

Measure	ITCA 650 20/20 n = 22	ITCA 650 20/60 n = 21	ITCA 650 40/40 n = 23	ITCA 650 40/80 n = 23	Ex Inj/ITCA 650 40 n = 22	Ex Inj/ITCA 650 60 n = 22
Value	-0.89 (0.660)	-1.26 (0.950)	-0.70 (0.892)	-1.36 (0.664)	-1.01 (0.823)	-1.51 (1.266)

Population analysed: Intent to treat analysis

Adverse events

Time frame: 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ITCA 650 20 mcg/Day	1 of 51 (2%)	39 of 51 (76.5%)	Not reported
ITCA 650 40 mcg/Day	0 of 51 (0%)	43 of 51 (84.3%)	Not reported
Exenatide Injection	0 of 53 (0%)	38 of 53 (71.7%)	Not reported
ITCA 650 20/20	1 of 20 (5%)	11 of 20 (55%)	Not reported
ITCA 650 20/60	1 of 21 (4.8%)	15 of 21 (71.4%)	Not reported
ITCA 650 40/40	2 of 23 (8.7%)	18 of 23 (78.3%)	Not reported
ITCA 650 40/80	2 of 23 (8.7%)	18 of 23 (78.3%)	Not reported
Ex Inj/ITCA 650 40	0 of 23 (0%)	18 of 23 (78.3%)	Not reported
Ex Inj/ITCA 650 60	0 of 21 (0%)	18 of 21 (85.7%)	Not reported
ITCA 650 20/20 Continuation	0 of 15 (0%)	2 of 15 (13.3%)	Not reported
ITCA 650 20/60 Continuation	1 of 15 (6.7%)	3 of 15 (20%)	Not reported
ITCA 650 40/40 Continuation	1 of 13 (7.7%)	3 of 13 (23.1%)	Not reported
ITCA 650 40/80 Continuation	2 of 16 (12.5%)	6 of 16 (37.5%)	Not reported
Ex Inj/ITCA 40 Continuation	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
Ex Inj/ITCA 650 60 Continutation	0 of 12 (0%)	4 of 12 (33.3%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23645886Henry 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

50 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ITCA 650, Exenatide Injection and Ex Inj/ITCA 650 in people with Type 2 Diabetes, run by Intarcia Therapeutics at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in HbA1c (Per Protocol) (time frame: Day 0 and Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00943917, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.