Exeantide in Type 2 Diabetes on Insulin

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT01154933
First received: June 30, 2010
Last updated: December 14, 2012
Last verified: December 2012

June 30, 2010
December 14, 2012
April 2008
November 2011   (final data collection date for primary outcome measure)
insulin dose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01154933 on ClinicalTrials.gov Archive Site
  • weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Exeantide in Type 2 Diabetes on Insulin
The Effect of Exenatide on Insulin Requirement, Weight and Inflammation in Obese Type 2 Diabetic Subjects 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: exenatide 5 mcg
    exenatide 5 mcg
    Other Name: exenatide 5 mcg
  • Drug: exenatide 10 mcg
    exenatide 10 mcg
    Other Name: exenatide 10 mcg
  • Drug: placebo
    saline sq
    Other Name: placebo
  • Experimental: exenatide 5 mcg
    exenatide 5 mcg
    Intervention: Drug: exenatide 5 mcg
  • Experimental: exenatide 10 mcg
    exenatide 10 mcg
    Intervention: Drug: exenatide 10 mcg
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01154933
1930
No
Paresh Dandona, MD, Kaleida Health
Kaleida Health
Amylin Pharmaceuticals, LLC.
Principal Investigator: Paresh Dandona, MBBS SUNY at Buffalo
Kaleida Health
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP