Primary outcomeMean· after 24 hours fast at baseline and 12 weeks
Fasting Insulin
| Group | Value (μU/mL) | Spread |
|---|---|---|
| Exenatide 10 mcg | 12.7 | 2.8 |
| Placebo | 13.1 | 3.1 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataExeantide in Type 2 Diabetes on Insulin
NCTNCT01154933 (opens ClinicalTrials.gov in a new tab)Other id1930
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 24 participants (actual)
- Sponsor
- University at Buffalo · Other
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- Apr 2008
- Primary completion
- Nov 2011
- Completion
- Nov 2011
- First posted
- 1 Jul 2010 (estimated)
- Last update posted
- 6 Oct 2022
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20082009201020112012
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- exenatide 5 mcgDrug
- exenatide 10 mcgDrug
- placeboDrug
Arms3
Experimental
exenatide 5 mcg
exenatide 5 mcg
Experimental
exenatide 10 mcg
exenatide 10 mcg
Placebo comparator
placebo
placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Fasting Insulin
Time frame · after 24 hours fast at baseline and 12 weeks
Registry description
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.
Secondary outcomes(3)
Weight
Time frame · value at 12 weeks minus value at baseline
Registry description
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
HbA1c
Time frame · value at 12 weeks minus value at baseline
Registry description
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.
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
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeMean· value at 12 weeks minus value at baseline
Weight
| Group | Value (lbs) | Spread |
|---|---|---|
| Exenatide 10 mcg | 0 | 20 |
| Placebo | 3 | 18 |
Secondary outcomeMean· value at 12 weeks minus value at baseline
HbA1c
| Group | Value (percent) | Spread |
|---|---|---|
| Exenatide 10 mcg | -1.2 | 0.5 |
| Placebo | -0.5 | 0.3 |
Secondary outcomeMean· measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline
Intranuclear NFκB Binding Activity
| Group | Value (% ratio of NFKB/Oct-1) | Spread |
|---|---|---|
| Exenatide 10 mcg | 26 | 7 |
| Placebo | 0 | 7 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide 5mcg Then Exenatide 10 mcggiven exenatide 5mcg followed by exenatide 10mcg | – | 0 / 12 | 0 / 12 |
| Placeboplacebo placebo: saline sq | – | 0 / 12 | 0 / 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.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
7 results
Exenatide Increases IL-1RA Concentration and Induces Nrf-2‒Keap-1‒Regulated Antioxidant Enzymes: Relevance to β-Cell Function.
Dandona et al. 2018The Journal of clinical endocrinology and metabolismcited by 15
PMID 29346597DOI 10.1210/jc.2017-02343PUB-29346597
Rights unknown7 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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
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