Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus

Last updated: October 13, 2011
Sponsor: Cheryl Rosenfeld, DO
Overall Status: Trial Status Unknown

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT01137695
DEFCon2
  • Ages 18-80
  • All Genders

Study Summary

The hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do not respond to the FDA approved dose of 120 mcg of pramlintide (Symlin®) 3 times daily with expected glucose control require higher than FDA approved dosage.

The primary objective of the study is to determine whether higher doses of pramlintide (Symlin®) in patients with type 2 diabetes mellitus control glucose better than the FDA approved dose of 120 mcg three times daily.

The secondary objectives include proving whether higher dose pramlintide (Symlin®) is more efficacious in causing weight loss and reduction in waist circumference than standard dose pramlintide (Symlin®),to determine whether blood levels of certain hormones correlate with need for higher dose therapy,and to determine whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg three times daily.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-80 years.

  2. Type 2 diabetes mellitus.

  3. Obese (BMI > 30 kg/m2), waist circ. >35" women, >40" men.

  4. Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixedinsulin.

  5. On stable insulin dose for at least 3 mos (baseline + 20%, no minimum).

  6. If pramlintide treated, on stable full dose for at least 3 months.

  7. A1c > 7.0% and < 9.0%.

  8. Women of childbearing age if using a reliable form of birth control.

  9. Women of childbearing age if post tubal ligation or surgical menopause.

  10. Able to consent.

  11. Willing to perform self-monitoring of glucose.

  12. Willing to attend study visits.

  13. Written informed consent to participate in the study.

  14. Agreement to maintain prior diet and exercise throughout the full course of the study.

Exclusion

Exclusion Criteria:

  1. Age <18 or >80 years.

  2. Confirmed gastroparesis or taking medications affecting gastric motility.

  3. A1c <7.0% or >9.0%.

  4. Recurrent severe hypoglycemia or hypoglycemic unawareness.

  5. CHF.

  6. Creatinine clearance <30 ml/min.

  7. History of MI <6 mos prior to enrollment.

  8. History of ventricular arrhythmia.

  9. History of cancer or chemotherapy <6 mos prior to enrollment.

  10. Laboratory abnormalities as follows:

  11. Liver enzymes >3X ULN.

  12. Hematocrit less than 30.

  13. Serum creatinine >2.5 mg/dl.

  14. Fasting triglycerides >500 mg/dl.

  15. Cirrhosis.

  16. Pregnancy or nursing.

  17. Inability to provide consent.

  18. Unwilling to attend study visits.

  19. Unwilling to perform self-monitoring of glucose.

  20. Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening.

  21. Investigational drug treatment within 3 months prior to screening.

  22. Donation of blood, significant blood loss or transfusion within 3 months of screening.

  23. History of acromegaly or Cushing's syndrome.

  24. Use of prohibited concomitant medications.

  25. Type 1 diabetes mellitus.

  26. Acute metabolic complication (hyperosmolar state) <6 months prior to screening.

Study Design

Total Participants: 40
Study Start date:
May 01, 2010
Estimated Completion Date:
April 30, 2012

Connect with a study center

  • North Jersey Endocrine Consultants

    Denville, New Jersey 07834
    United States

    Site Not Available

  • University Physicians Group

    Staten Island, New York 10301
    United States

    Site Not Available

  • St. Mary Medical Center

    Langhorne, Pennsylvania 19047
    United States

    Site Not Available

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