Treatment satisfaction with ITCA 650, a novel drug-device delivering continuous exenatide, versus twice-daily injections of exenatide in type 2 diabetics using metformin.

Henry R, Rosenstock J, McCarthy JF, Carls G, Alessi T, Yee J, Baron M

Diabetes, obesity & metabolism20 Nov 2017Cited by 5 (Europe PMC)

PMID29053202DOI10.1111/dom.13133PepBankPUB-29053202

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In metformin-treated patients with T2D, ITCA 650 increased treatment satisfaction versus twice-daily exenatide at Week 8.
In plain wordsIn patients with diabetes, continuous exenatide improved treatment satisfaction compared with twice-daily injections.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseTreatment satisfaction at week 8
Study
n = 155
Comparator
Twice-daily exenatide
Outcome group
Patient-reported outcomes · Whole body
Studied dose
ITCA 650 20 or 40 μg/dayAs given in this study (human).
Source sentences
Summary
Patients using ITCA 650 reported significant increases in overall treatment satisfaction by Week 8 vs those using Ex-BID (P < .01), despite similar clinical efficacy and overall rates of nausea.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
Summary · context
In Stage I (Weeks 1-12), 155 patients, comprising the ITT population, were randomized to 3 groups: ITCA 650 20 μg/day, ITCA 650 40 μg/day and Ex-BID 10 μg BID.
Report a problemFND-2905320201
02HumanRandomized controlled trialEfficacy outcome
In patients with T2D, ITCA 650 and twice-daily exenatide had similar clinical efficacy.
In plain wordsIn patients with diabetes, continuous exenatide and twice-daily injections had similar clinical effects.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeClinical efficacy
Study
n = 155
Comparator
Twice-daily exenatide
Outcome group
Overall treatment effect · Whole body
Studied dose
ITCA 650 20 or 40 μg/dayAs given in this study (human).
Source sentences
Summary
Patients using ITCA 650 reported significant increases in overall treatment satisfaction by Week 8 vs those using Ex-BID (P < .01), despite similar clinical efficacy and overall rates of nausea.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
Summary · context
In Stage I (Weeks 1-12), 155 patients, comprising the ITT population, were randomized to 3 groups: ITCA 650 20 μg/day, ITCA 650 40 μg/day and Ex-BID 10 μg BID.
Report a problemFND-2905320202
03HumanRandomized controlled trialSafety outcome
In patients with T2D, overall nausea rates were similar with ITCA 650 and twice-daily exenatide.
In plain wordsIn patients with diabetes, nausea rates were similar with continuous exenatide and twice-daily injections.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeNausea
Study
n = 155
Comparator
Twice-daily exenatide
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
ITCA 650 20 or 40 μg/dayAs given in this study (human).
Source sentences
Summary
Patients using ITCA 650 reported significant increases in overall treatment satisfaction by Week 8 vs those using Ex-BID (P < .01), despite similar clinical efficacy and overall rates of nausea.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
Summary · context
In Stage I (Weeks 1-12), 155 patients, comprising the ITT population, were randomized to 3 groups: ITCA 650 20 μg/day, ITCA 650 40 μg/day and Ex-BID 10 μg BID.
Report a problemFND-2905320203
04HumanRandomized controlled trialEfficacy outcome
In patients with T2D, HbA1c improved further after ITCA 650 dose escalation during Stage II.
In plain wordsIn patients with diabetes, blood sugar control improved further after the continuous exenatide dose increased.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c after dose escalation
Study
n: not reported in source
Outcome group
Glycemic control · Metabolic and weight
Studied dose
3-fold dose escalation of ITCA 650As given in this study (human).
Source sentences
Summary
During Stage II, further improvement in HbA1c and weight were seen after 3-fold dose escalation of ITCA 650 and treatment satisfaction was maintained.
1 context sentence(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
Report a problemFND-2905320204
05HumanRandomized controlled trialEfficacy outcome
In patients with T2D, weight improved further after ITCA 650 dose escalation during Stage II.
In plain wordsIn patients with diabetes, weight improved further after the continuous exenatide dose increased.
Peptide
Exenatide (exendin-4)
Outcome
Direction not reportedWeight after dose escalation
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
3-fold dose escalation of ITCA 650As given in this study (human).
Source sentences
Summary
During Stage II, further improvement in HbA1c and weight were seen after 3-fold dose escalation of ITCA 650 and treatment satisfaction was maintained.
1 context sentence(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
Report a problemFND-2905320205
06HumanRandomized controlled trialEfficacy outcome
In patients with T2D, treatment satisfaction was maintained after ITCA 650 dose escalation.
In plain wordsIn patients with diabetes, treatment satisfaction remained stable after the continuous exenatide dose increased.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeTreatment satisfaction after dose escalation
Study
n: not reported in source
Outcome group
Patient-reported outcomes · Whole body
Studied dose
3-fold dose escalation of ITCA 650As given in this study (human).
Source sentences
Summary
During Stage II, further improvement in HbA1c and weight were seen after 3-fold dose escalation of ITCA 650 and treatment satisfaction was maintained.
1 context sentence(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
Report a problemFND-2905320206
07HumanRandomized controlled trialEfficacy outcome
In patients with T2D, satisfaction increased after switching from twice-daily exenatide to ITCA 650 and reached initial ITCA 650 recipients' levels.
In plain wordsIn patients with diabetes, satisfaction increased after switching to continuous exenatide and reached levels reported by initial users.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseTreatment satisfaction after switching
Study
n: not reported in source
Outcome group
Patient-reported outcomes · Whole body
Studied dose
40 or 60 μg/day ITCA 650As given in this study (human).
Source sentences
Summary
When patients using Ex-BID were switched to ITCA 650, treatment satisfaction increased and reached levels similar to those initially treated with ITCA 650.
2 context sentences(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
Summary · context
Patients treated with Ex-BID were randomized to 40 or 60 μg/day ITCA 650.
Report a problemFND-2905320207

Studies that did not test the peptide alone1

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

08HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialOther
In patients with T2D, nausea or vomiting and subdermal ITCA 650 placement did not significantly affect treatment satisfaction scores.
In plain wordsIn patients with diabetes, nausea, vomiting, and device placement did not significantly affect satisfaction with continuous exenatide.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeAdverse effects and placement versus satisfaction
Study
n: not reported in source
Outcome group
Patient-reported outcomes · Whole body
Source sentences
Summary
Neither GI side effects of nausea and/or vomiting, nor the procedure to sub-dermally place ITCA 650, significantly impacted treatment satisfaction scores.
1 context sentence(design, population, supporting numbers)
Summary · context
To evaluate treatment satisfaction in patients with type 2 diabetes (T2D) not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) vs twice-daily exenatide injections (Ex-BID).
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-2905320208

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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Treatment satisfaction with ITCA 650, a novel drug-device delivering continuous exenatide, versus twice-daily injections of exenatide in type 2 diabetics using metformin.

Summary

Results from this study8

Studies that did not test the peptide alone1

Version history

Subjects

Publication types

MeSH terms

Keywords