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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00943917 (opens ClinicalTrials.gov in a new tab)Other idITCA 650-CLP-02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
155 participants (actual)
Sponsor
Intarcia Therapeutics · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2009
Primary completion
Aug 2010
Completion
Feb 2011
First posted
22 Jul 2009 (estimated)
Last update posted
13 Apr 2015 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 2

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

    NCT00943917

    Aug 2009 to Feb 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ITCA 650Other
  • Exenatide InjectionDrug
  • Ex Inj/ITCA 650Other

Arms9

  • Experimental

    ITCA 650 20 mcg/day

  • Experimental

    ITCA 650 40 mcg/day

  • Active comparator

    Exenatide Injection

  • Experimental

    ITCA 650 20/20

  • Experimental

    ITCA 650 20/60

  • Experimental

    ITCA 650 40/40

  • Experimental

    ITCA 650 40/80

  • Experimental

    Ex Inj/ITCA 650 40

  • Experimental

    Ex Inj/ITCA 650 60

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Mean Change in HbA1c (Per Protocol)

    Time frame · Day 0 and Week 12

    Registry description

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

  2. Mean Change in HbA1c (ITT)

    Time frame · Day 0 to Week 12

    Registry description

    Mean change in HbA1c through Week 12

  3. Mean Change in HbA1c (Per Protocol)

    Time frame · Day 0 to Week 24

    Registry description

    Mean change in HbA1c through Week 24

  4. Mean Change in HbA1c (ITT)

    Time frame · Day 0 to Week 24

    Registry description

    Mean change in HbA1c through Week 24

  5. Mean Change in HbA1c (Per Protocol)

    Time frame · Day 0 to Week 48

    Registry description

    Mean change in HbA1c through Week 48

  6. Mean Change in HbA1c (ITT)

    Time frame · Day 0 to Week 48

    Registry description

    Mean change in HbA1c through Week 48

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Day 0 and Week 12

Mean Change in HbA1c (Per Protocol)

GroupValue (percent change)Spread
ITCA 650 20 mcg/Day - STAGE I-0.960.905
ITCA 650 40 mcg/Day - STAGE I-1.040.713
Exenatide Injection - STAGE I-0.820.870
Primary outcomeMean· Day 0 to Week 12

Mean Change in HbA1c (ITT)

GroupValue (percent change)Spread
ITCA 650 20 mcg/Day - STAGE I-.930.882
ITCA 650 40 mcg/Day - STAGE I-0.960.724
Exenatide Injection - STAGE I-0.750.866
Primary outcomeMean· Day 0 to Week 24

Mean Change in HbA1c (Per Protocol)

GroupValue (percent change)Spread
ITCA 650 20/20-.89.660
ITCA 650 20/60-1.26.950
ITCA 650 40/40-0.67.908
ITCA 650 40/80-1.360.664
Ex Inj/ITCA 650 40-1.010.823
Ex Inj/ITCA 650 60-1.511.266
Primary outcomeMean· Day 0 to Week 24

Mean Change in HbA1c (ITT)

GroupValue (percent change)Spread
ITCA 650 20/20-0.890.660
ITCA 650 20/60-1.260.950
ITCA 650 40/40-0.700.892
ITCA 650 40/80-1.360.664
Ex Inj/ITCA 650 40-1.010.823
Ex Inj/ITCA 650 60-1.511.266
Primary outcomeMean· Day 0 to Week 48

Mean Change in HbA1c (Per Protocol)

GroupValue (percent change)Spread
ITCA 650 20/20-1.000.493
ITCA 650 20/60-1.230.908
ITCA 650 40/40-0.691.182
ITCA 650 40/80-1.370.837
Ex Inj/ITCA 650 40-1.450.895
Ex Inj/ITCA 650 60-1.881.212
Primary outcomeMean· Day 0 to Week 48

Mean Change in HbA1c (ITT)

GroupValue (percent change)Spread
ITCA 650 20/20-1.130.651
ITCA 650 20/60-1.250.880
ITCA 650 40/40-0.481.555
ITCA 650 40/80-1.400.803
Ex Inj/ITCA 650 40-1.160.988
Ex Inj/ITCA 650 60-1.841.570

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ITCA 650 20 mcg/DayITCA 650 20 mcg/day continuous exenatide–1 / 5139 / 51
ITCA 650 40 mcg/DayITCA 650 40 mcg/day continuous exenatide–0 / 5143 / 51
Exenatide Injectionexenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks–0 / 5338 / 53
ITCA 650 20/20ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day–1 / 2011 / 20
ITCA 650 20/60ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day–1 / 2115 / 21
ITCA 650 40/40ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day–2 / 2318 / 23
ITCA 650 40/80ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day–2 / 2318 / 23
Ex Inj/ITCA 650 40Exenatide injection first 12 weeks then ITCA 650 40 mcg/day–0 / 2318 / 23
Ex Inj/ITCA 650 60Exenatide injection first 12 weeks then ITCA 650 60 mcg/day–0 / 2118 / 21
ITCA 650 20/20 ContinuationITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48–0 / 152 / 15
ITCA 650 20/60 ContinuationITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48–1 / 153 / 15
ITCA 650 40/40 ContinuationITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48–1 / 133 / 13
ITCA 650 40/80 ContinuationITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48–2 / 166 / 16
Ex Inj/ITCA 40 ContinuationExenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48–0 / 154 / 15
Ex Inj/ITCA 650 60 ContinutationExenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48–0 / 124 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2013

Corrected

Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes.

Henry et al. 2013Diabetes carecited by 33

PMID 23645886PMC3747935DOI 10.2337/dc12-2410PUB-23645886

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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