Exeantide in Type 2 Diabetes on Insulin
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ClinicalTrials.gov Identifier: NCT01154933 |
Recruitment Status :
Completed
First Posted : July 1, 2010
Last Update Posted : December 17, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: exenatide 5 mcg Drug: exenatide 10 mcg Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: exenatide 5 mcg
exenatide 5 mcg
|
Drug: exenatide 5 mcg
exenatide 5 mcg |
Experimental: exenatide 10 mcg
exenatide 10 mcg
|
Drug: exenatide 10 mcg
exenatide 10 mcg |
Placebo Comparator: placebo
placebo
|
Drug: placebo
saline sq |
- insulin dose [ Time Frame: 12 weeks ]To compare the total insulin dose 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.
- weight [ Time Frame: 12 weeks ]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: 12 weeks ]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.
- inflammation [ Time Frame: 12 weeks ]To investigate the hypothesis that a single dose of exenatide subcutaneously (5 mcg/injection) decreases the intranuclear NFκB binding activity and decreases the transcription of pro-inflammatory genes regulated by NFκB in MNC's of insulin treated type 2 diabetic patients as compared to placebo.

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154933
United States, New York | |
Millard Fillmore Gates Hospital | |
Buffalo, New York, United States, 14209 |
Principal Investigator: | Paresh Dandona, MBBS | SUNY at Buffalo |
Responsible Party: | Paresh Dandona, MD, MD, Kaleida Health |
ClinicalTrials.gov Identifier: | NCT01154933 |
Other Study ID Numbers: |
1930 |
First Posted: | July 1, 2010 Key Record Dates |
Last Update Posted: | December 17, 2012 |
Last Verified: | December 2012 |
type 2 diabetes obesity |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |