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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Symlin® Dose Escalation Efficacy vs. Conventional Therapy in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01137695
• Other study ID #: DEFCon2
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 3, 2010
• Last updated: October 13, 2011
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: October 2011
• Source: North Jersey Endocrine Consultants, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	North Jersey Endocrine Consultants	Denville	New Jersey
United States	St. Mary Medical Center	Langhorne	Pennsylvania
United States	University Physicians Group	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cheryl Rosenfeld, DO	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose control	A1c Fasting plasma glucose Post-prandial glucose Glycomark	6 months	No
Secondary	Weight loss	Weight, BMI, Waist circumference.	6 months	No
Secondary	amylin level	does initial blood amylin level correlate with need for higher dose pramlintide?	initial	No
Secondary	glucagon level	Does change in glucagon level correlate with glycemic response.	6 months	No
Secondary	adverse effects	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%.	6 months	Yes