Type 2 DiabetesPhase 2NCT01154933
Exeantide in Type 2 Diabetes on Insulin
A Phase 2 study testing exenatide 5 mcg and exenatide 10 mcg in people with Type 2 Diabetes, run by University at Buffalo at 1 site in United States.
Trial summary
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- exenatide 5 mcg and exenatide 10 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 20-75 years of age inclusive.
- Type 2 diabetes
- On insulin therapy
- HbA1c ≥7.5% and ≤ 9%
- BMI ≥ 30 kg/m2
- Subjects on statins, ACE inhibitors, metformin, thiazolidinediones and antioxidants will be allowed as long as they are on stable doses of these compounds and the dosage in not changed during the study.
Who cannot join
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
- Pregnancy
- Hepatic disease (abnormal LFT's)
- Use of DPP4 inhibitors.
- Renal impairment (serum creatinine > 1.5)
- Participation in any other concurrent clinical trial
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- Any other life-threatening, non-cardiac disease
- Uncontrolled hypertension (BP > 160/100 mm of Hg)
- Congestive Heart Failure.
- Use of an investigational agent or therapeutic regimen within 30 days of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Millard Fillmore Gates Hospital
Buffalo, New York, 14209
About this study
Official title: The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.
The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.
- Conditions
- Type 2 Diabetes
- Being tested
- exenatide 5 mcg, exenatide 10 mcg, placebo
- Keywords
- type 2 diabetes, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exenatide 5 mcgDrug
exenatide 5 mcg
exenatide 10 mcgDrug
exenatide 10 mcg
placeboDrug
saline sq
| Study group | Role | What they receive |
|---|---|---|
| exenatide 5 mcg | Experimental | exenatide 5 mcg Receives: Drug: exenatide 5 mcg |
| exenatide 10 mcg | Experimental | exenatide 10 mcg Receives: Drug: exenatide 10 mcg |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Insulin
To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.
Measured: after 24 hours fast at baseline and 12 weeks
Secondary outcomes (3)
Weight
To compare the body weight at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients
Measured: value at 12 weeks minus value at baseline
HbA1c
To compare the HbA1c at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.
Measured: value at 12 weeks minus value at baseline
Intranuclear NFκB Binding Activity
Measured by a gel shift assay showing the NFKB and Oct-1 binding to the doublestranded oligonucleotide containing the NFKB DNA binding site in Exenatide group and placebo group
Measured: measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startApr 2008
- Primary completionNov 2011
- Study completionNov 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Responsible party
- Principal investigator, Paresh Dandona, Kaleida Health
- Investigators
- Paresh Dandona, MBBS, Principal investigator, SUNY at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154933
- Sponsor's protocol ID
- 1930
- Status last verified
- Sep 2022
- First submitted
- 30 Jun 2010
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dandona P, Ghanim H, Abuaysheh S, Green K, Dhindsa S, Makdissi A, Batra M, Kuhadiya ND, Chaudhuri A. Exenatide Increases IL-1RA Concentration and Induces Nrf-2-Keap-1-Regulated Antioxidant Enzymes: Relevance to beta-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343.
PubMed 29346597
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin
- ClinicalTrials.gov ID
- NCT01154933
- Acronym / sponsor ID
- 1930
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Amylin Pharmaceuticals, LLC.
- Study start
- Apr 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 6 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss.
The purpose of this study is to determine if the addition of Exenatide to diabetic patients will reduce the requirements of insulin particularly the short acting insulin. Exenatide may also lead to decreased inflammation by virtue of better glycemic control and weight loss, or an independent effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exenatide 5 mcg | Experimental | Drug: exenatide 5 mcgexenatide 5 mcg |
| exenatide 10 mcg | Experimental | Drug: exenatide 10 mcgexenatide 10 mcg |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females 20-75 years of age inclusive.
- Type 2 diabetes
- On insulin therapy
- HbA1c ≥7.5% and ≤ 9%
- BMI ≥ 30 kg/m2
Key exclusion criteria (10 listed)
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
- Pregnancy
- Hepatic disease (abnormal LFT's)
- Use of DPP4 inhibitors.
- Renal impairment (serum creatinine > 1.5)
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 |
|---|---|---|
| exenatide 5 mcgexenatide 5 mcg | Drug | exenatide 5 mcg |
| exenatide 10 mcgexenatide 10 mcg | Drug | exenatide 10 mcg |
| placebosaline sq | Drug | placebo |
Primary outcome
Fasting Insulin
Time frame: after 24 hours fast at baseline and 12 weeks
To compare the fasting insulin level at the end of 12 weeks in patients on exenatide subcutaneously twice daily (5 or 10 mcg/injection) as compared to controls in insulin treated obese type 2 diabetic patients.
3 secondary outcomes
Weight
Time frame: value at 12 weeks minus value at baseline
HbA1c
Time frame: value at 12 weeks minus value at baseline
Intranuclear NFκB Binding Activity
Time frame: measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29346597Dandona P, Ghanim H, Abuaysheh S, Green K, Dhindsa S, Makdissi A, Batra M, Kuhadiya ND, Chaudhuri A. Exenatide Increases IL-1RA Concentration and Induces Nrf-2-Keap-1-Regulated Antioxidant Enzymes: Relevance to beta-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343.
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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.
Paresh Dandona, MBBS principal investigator
SUNY at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exenatide 5 mcg and exenatide 10 mcg in people with Type 2 Diabetes, run by University at Buffalo at 1 site 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 6 inclusion and 10 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 6 Oct 2022). 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?
Fasting Insulin (time frame: after 24 hours fast at baseline and 12 weeks). 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 NCT01154933, 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 6 Oct 2022.