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

Overview

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.

Full Title of Study: “Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2012

Interventions

  • Drug: Pramlintide
    • 120 mcg SQ three times daily for 6 months.
  • Drug: Pramlintide
    • 360 mcg SQ three times daily for 6 months
  • Drug: Pramlintide
    • 120 mcg SQ three times daily for 6 months
  • Drug: Pramlintide
    • 360 mcg SQ three times daily for 6 months

Arms, Groups and Cohorts

  • Active Comparator: Symlin Naive, Usual Dose
    • Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.
  • Experimental: Symlin Naive, Dose Escalation
    • Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.
  • Active Comparator: Symlin treated, Usual Dose
    • pramlintide 120 mcg three times daily in patients who have been treated with pramlintide 120 mcg prior to the trial.
  • Experimental: Symlin Treated, Dose Escalation
    • pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.

Clinical Trial Outcome Measures

Primary Measures

  • Glucose control
    • Time Frame: 6 months
    • A1c Fasting plasma glucose Post-prandial glucose Glycomark

Secondary Measures

  • Weight loss
    • Time Frame: 6 months
    • Weight, BMI, Waist circumference.
  • amylin level
    • Time Frame: initial
    • does initial blood amylin level correlate with need for higher dose pramlintide?
  • glucagon level
    • Time Frame: 6 months
    • Does change in glucagon level correlate with glycemic response.
  • adverse effects
    • Time Frame: 6 months
    • Whether or not the rate of common adverse effects exceeds the maximum FDA approved pramlintide (Symlin®) dose of 120 mcg TID (as compared to the clinical practice study) – GI: nausea 30% and Hypoglycemia: medically assisted 0.7% or patient ascertained 0.7%.

Participating in This Clinical Trial

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-mixed insulin.

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 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:

1. Liver enzymes >3X ULN.

2. Hematocrit less than 30.

3. Serum creatinine >2.5 mg/dl.

4. Fasting triglycerides >500 mg/dl.

11. Cirrhosis.

12. Pregnancy or nursing.

13. Inability to provide consent.

14. Unwilling to attend study visits.

15. Unwilling to perform self-monitoring of glucose.

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

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

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

19. History of acromegaly or Cushing's syndrome.

20. Use of prohibited concomitant medications.

21. Type 1 diabetes mellitus.

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cheryl Rosenfeld, DO
  • Collaborator
    • Amylin Pharmaceuticals, LLC.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Cheryl Rosenfeld, DO, Principal Investigator – North Jersey Endocrine Consultants, LLC
  • Overall Official(s)
    • Cheryl Rosenfeld, DO, Principal Investigator, North Jersey Endocrine Consultants
    • Jeffrey Rothman, MD, Principal Investigator, University Physicians Group Research
    • Alan Schorr, DO, Principal Investigator, St. Mary Medical Center

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