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Trial · Interventional

CompletedPhase 1Results postedRegistry data

Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

NCTNCT01798264 (opens ClinicalTrials.gov in a new tab)Other idITCA 650-CLP-01
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Feb 2009
Primary completion
May 2009
Completion
May 2009
First posted
25 Feb 2013 (estimated)
Last update posted
17 May 2013 (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
20092010
  1. Ph 1

    Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

    NCT01798264

    Feb 2009 to May 2009

Registry summary

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

evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

Interventions

  • ITCA 650 (exenatide in DUROS)Drug

Arms4

  • Experimental

    10 mcg./day

    ITCA 650 (exenatide in DUROS)

  • Experimental

    20 mcg/day

    ITCA 650 (exenatide in DUROS)

  • Experimental

    40 mcg/day

    ITCA 650 (exenatide in DUROS)

  • Experimental

    80 mcg/day

    ITCA 650 (exenatide in DUROS)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Subjects With Study Drug-Related Adverse Events

    Time frame · 4 weeks

Secondary outcomes(3)

  1. To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

    Time frame · 4 weeks

    Registry description

    Change in HbA1c from baseline

  2. Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline

    Time frame · 4 weeks

  3. Change in Weight From Baseline to 4 Weeks

    Time frame · 4 weeks

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 outcomeNumber· 4 weeks

Number of Subjects With Study Drug-Related Adverse Events

GroupValue (participants)
10 Mcg/Day9
20 Mcg/Day11
40 Mcg/Day9
80 Mcg/Day11
Secondary and other outcome results(3)
Secondary outcomeMean· 4 weeks

To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

GroupValue (percentage)Spread
10 Mcg/Day-0.50.39
20 Mcg/Day-0.60.31
40 Mcg/Day-0.50.31
80 Mcg/Day-0.70.36
Secondary outcomeMean· 4 weeks

Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline

GroupValue (mg/dL)Spread
10 Mcg/Day-5.634.33
20 Mcg/Day-31.224.2
40 Mcg/Day-42.033.16
80 Mcg/Day-28.833.5
Secondary outcomeMean· 4 weeks

Change in Weight From Baseline to 4 Weeks

GroupValue (kg)Spread
10 Mcg/Day-0.30.91
20 Mcg/Day-0.31.51
40 Mcg/Day-1.11.6
80 Mcg/Day-3.12.13

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
10 Mcg/DayITCA 650 (exenatide in DUROS)–0 / 1212 / 12
20 Mcg/DayITCA 650 (exenatide in DUROS)–0 / 1111 / 11
40 Mcg/DayITCA 650 (exenatide in DUROS)–0 / 109 / 10
80 Mcg/DayITCA 650 (exenatide in DUROS)–0 / 1111 / 11

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

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedHenry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013 May;35(5):634-645.e1. doi: 10.1016/j.clinthera.2013.03.011. Epub 2013 Apr 8. PMID 23578605

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * type 2 diabetes \>6 months * stable diet \& exercise, metformin, TZD or met + TZD HbA1c \>6.5% \<10.0% Exclusion Criteria: * prior treatment with exenatide * history of pancreatitis * history of medullary thyroid cancer or multiple endocrine neoplasia 2

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