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OpenTrials
Completed

NCT Number: NCT01154933

Exeantide in Type 2 Diabetes 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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Millard Fillmore Gates Hospital

Buffalo, New York, 14209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide 5 mcg

Drug

exenatide 5 mcg

exenatide 10 mcg

Drug

exenatide 10 mcg

Placebo

Drug

saline sq

Primary outcomes

  1. 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.

Secondary outcomes

  1. Weight

    Time frame: value at 12 weeks minus value at baseline

    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: value at 12 weeks minus value at baseline

    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. 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

    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

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Collaborators

  • Amylin Pharmaceuticals, LLC.

Registry information

Official study title

The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects on Insulin

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2010
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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