Exeantide in Type 2 Diabetes on Insulin

• ClinicalTrials.gov Identifier: NCT01154933
• Recruitment Status: Completed
• First Posted: July 1, 2010
• Last Update Posted: December 17, 2012
• Sponsor: Kaleida Health
• Collaborator: Amylin Pharmaceuticals, LLC.
• Information provided by (Responsible Party): Paresh Dandona, MD, Kaleida Health

Study Description

Brief 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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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.
3. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

Millard Fillmore Gates Hospital

Buffalo, New York, United States, 14209

Sponsors and Collaborators

Kaleida Health

Amylin Pharmaceuticals, LLC.

Investigators

• Principal Investigator: Paresh Dandona, MBBS; SUNY at Buffalo

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 β-Cell Function. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1180-1187. doi: 10.1210/jc.2017-02343.

• Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
• ClinicalTrials.gov Identifier: NCT01154933
• Other Study ID Numbers: 1930
• First Posted: July 1, 2010
• Last Update Posted: December 17, 2012
• Last Verified: December 2012

Keywords provided by Paresh Dandona, MD, Kaleida Health:

type 2 diabetes; obesity

Additional relevant MeSH terms:

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