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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Pramlintide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by North Jersey Endocrine Consultants, LLC:

Primary Outcome Measures:
  • Glucose control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A1c Fasting plasma glucose Post-prandial glucose Glycomark


Secondary Outcome Measures:
  • 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%.


Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Symlin Naive, Usual Dose
Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.
Drug: Pramlintide
120 mcg SQ three times daily for 6 months.
Experimental: Symlin Naive, Dose Escalation
Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.
Drug: Pramlintide
360 mcg SQ three times daily for 6 months
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.
Drug: Pramlintide
120 mcg SQ three times daily for 6 months
Experimental: Symlin Treated, Dose Escalation
pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.
Drug: Pramlintide
360 mcg SQ three times daily for 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137695

Locations
United States, New Jersey
North Jersey Endocrine Consultants
Denville, New Jersey, United States, 07834
United States, New York
University Physicians Group
Staten Island, New York, United States, 10301
United States, Pennsylvania
St. Mary Medical Center
Langhorne, Pennsylvania, United States, 19047
Sponsors and Collaborators
Cheryl Rosenfeld, DO
Amylin Pharmaceuticals, LLC.
Investigators
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
  More Information

No publications provided

Responsible Party: Cheryl Rosenfeld, DO, Principal Investigator, North Jersey Endocrine Consultants, LLC
ClinicalTrials.gov Identifier: NCT01137695     History of Changes
Other Study ID Numbers: DEFCon2
Study First Received: June 3, 2010
Last Updated: October 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by North Jersey Endocrine Consultants, LLC:
pramlintide
glucose
type 2 diabetes mellitus
amylin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014