Exeantide in Type 2 Diabetes on Insulin

NCT01154933 | Completed Phase 2 Results

• 1 other identifier: 1930
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  after 24 hours fast at baseline and 12 weeks

Secondary Outcomes (3)

• Weight

  value at 12 weeks minus value at baseline

• HbA1c

  value at 12 weeks minus value at baseline

• Intranuclear NFκB Binding Activity

  measured after 6 hours of a single dose of placebo or exenatide treatment for value measured at 12 weeks minus baseline

Study Arms (3)

exenatide 5 mcg

EXPERIMENTAL

exenatide 5 mcg

Drug: exenatide 5 mcg

exenatide 10 mcg

EXPERIMENTAL

exenatide 10 mcg

Drug: exenatide 10 mcg

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

exenatide 5 mcg DRUG

exenatide 5 mcg

exenatide 5 mcg

exenatide 10 mcg DRUG

exenatide 10 mcg

exenatide 10 mcg

placebo DRUG

saline sq

placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

Millard Fillmore Gates Hospital

Buffalo, New York, 14209, United States

Location

Related Publications (1)

• 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.

  PMID: 29346597 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Paresh Dandona
• Organization: State University of NY at Buffalo

dandona@buffalo.edu

7165351850

Study Officials

• Paresh Dandona, MBBS

  SUNY at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 1, 2010
• Study Start: April 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 6, 2022
• Results First Posted: October 6, 2022

Record last verified: 2022-09

Locations

US (1)