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

NCT01137695 | Unknown Phase 3

• 1 other identifier: DEFCon2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

pramlintide; glucose; type 2 diabetes mellitus; amylin

Outcome Measures

Primary Outcomes (1)

• Glucose control

  A1c Fasting plasma glucose Post-prandial glucose Glycomark

  6 months

Secondary Outcomes (4)

• Weight loss

  6 months

• amylin level

  initial

• glucagon level

  6 months

• adverse effects

  6 months

Study Arms (4)

Symlin Naive, Usual Dose

ACTIVE COMPARATOR

Symlin 120 mcg three times daily in patients not previously treated with pramlintide before the study.

Drug: Pramlintide

Symlin Naive, Dose Escalation

EXPERIMENTAL

Escalation of pramlintide dose to 360 mcg three times daily in patients not taking pramlintide prior to study.

Drug: Pramlintide

Symlin treated, Usual Dose

ACTIVE COMPARATOR

pramlintide 120 mcg three times daily in patients who have been treated with pramlintide 120 mcg prior to the trial.

Drug: Pramlintide

Symlin Treated, Dose Escalation

EXPERIMENTAL

pramlintide 360 mcg three times daily in patients previously treated with 120 mcg prior to the study.

Drug: Pramlintide

Interventions

Pramlintide DRUG

120 mcg SQ three times daily for 6 months.

Symlin Naive, Usual Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Type 2 diabetes mellitus.
• Obese (BMI \> 30 kg/m2), waist circ. \>35" women, \>40" men.
• Basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin.
• On stable insulin dose for at least 3 mos (baseline + 20%, no minimum).
• If pramlintide treated, on stable full dose for at least 3 months.
• A1c \> 7.0% and \< 9.0%.
• Women of childbearing age if using a reliable form of birth control.
• Women of childbearing age if post tubal ligation or surgical menopause.
• Able to consent.
• Willing to perform self-monitoring of glucose.
• Willing to attend study visits.
• Written informed consent to participate in the study.
• Agreement to maintain prior diet and exercise throughout the full course of the study.

You may not qualify if:

• Age \<18 or \>80 years.
• Confirmed gastroparesis or taking medications affecting gastric motility.
• A1c \<7.0% or \>9.0%.
• Recurrent severe hypoglycemia or hypoglycemic unawareness.
• CHF.
• Creatinine clearance \<30 ml/min.
• History of MI \<6 mos prior to enrollment.
• History of ventricular arrhythmia.
• History of cancer or chemotherapy \<6 mos prior to enrollment.
• Laboratory abnormalities as follows:
• Liver enzymes \>3X ULN.
• Hematocrit less than 30.
• Serum creatinine \>2.5 mg/dl.
• Fasting triglycerides \>500 mg/dl.
• Cirrhosis.

Sponsors & Collaborators

• Cheryl Rosenfeld, DO: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (3)

North Jersey Endocrine Consultants

Denville, New Jersey, 07834, United States

Location

University Physicians Group

Staten Island, New York, 10301, United States

Location

St. Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cheryl Rosenfeld, DO

  North Jersey Endocrine Consultants

  PRINCIPAL INVESTIGATOR

• Jeffrey Rothman, MD

  University Physicians Group Research

  PRINCIPAL INVESTIGATOR

• Alan Schorr, DO

  St. Mary's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 14, 2011

Record last verified: 2011-10

Locations

US (3)