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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by North Jersey Endocrine Consultants, LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Cheryl Rosenfeld, DO, North Jersey Endocrine Consultants, LLC
ClinicalTrials.gov Identifier:
NCT01137695
First received: June 3, 2010
Last updated: October 13, 2011
Last verified: October 2011

June 3, 2010
October 13, 2011
May 2010
January 2012   (final data collection date for primary outcome measure)
Glucose control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
A1c Fasting plasma glucose Post-prandial glucose Glycomark
Same as current
Complete list of historical versions of study NCT01137695 on ClinicalTrials.gov Archive Site
  • Weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Weight, BMI, Waist circumference.
  • amylin level [ Time Frame: initial ] [ Designated as safety issue: No ]
    does initial blood amylin level correlate with need for higher dose pramlintide?
  • glucagon level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Does change in glucagon level correlate with glycemic response.
  • adverse effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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%.
Same as current
Not Provided
Not Provided
 
Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Active Comparator: Symlin Naive, Usual Dose
    Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.
    Intervention: Drug: Pramlintide
  • Experimental: Symlin Naive, Dose Escalation
    Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.
    Intervention: Drug: Pramlintide
  • 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.
    Intervention: Drug: Pramlintide
  • Experimental: Symlin Treated, Dose Escalation
    pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.
    Intervention: Drug: Pramlintide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
April 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01137695
DEFCon2
No
Cheryl Rosenfeld, DO, North Jersey Endocrine Consultants, LLC
Cheryl Rosenfeld, DO
Amylin Pharmaceuticals, LLC.
Principal Investigator: Cheryl Rosenfeld, DO North Jersey Endocrine Consultants
Principal Investigator: Jeffrey Rothman, MD University Physicians Group Research
Principal Investigator: Alan Schorr, DO St. Mary Medical Center
North Jersey Endocrine Consultants, LLC
October 2011

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