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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Pramlintide

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring pramlintide, glucose, type 2 diabetes mellitus, amylin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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:
1. Liver enzymes >3X ULN.
2. Hematocrit less than 30.
3. Serum creatinine >2.5 mg/dl.
4. Fasting triglycerides >500 mg/dl.
Cirrhosis.
Pregnancy or nursing.
Inability to provide consent.
Unwilling to attend study visits.
Unwilling to perform self-monitoring of glucose.
Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening.
Investigational drug treatment within 3 months prior to screening.
Donation of blood, significant blood loss or transfusion within 3 months of screening.
History of acromegaly or Cushing's syndrome.
Use of prohibited concomitant medications.
Type 1 diabetes mellitus.
Acute metabolic complication (hyperosmolar state) <6 months prior to screening.

Sites / Locations

North Jersey Endocrine Consultants
University Physicians Group
St. Mary Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Symlin Naive, Usual Dose

Symlin Naive, Dose Escalation

Symlin treated, Usual Dose

Symlin Treated, Dose Escalation

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Glucose control

A1c Fasting plasma glucose Post-prandial glucose Glycomark

Secondary Outcome Measures

Weight loss

Weight, BMI, Waist circumference.

amylin level

does initial blood amylin level correlate with need for higher dose pramlintide?

glucagon level

Does change in glucagon level correlate with glycemic response.

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%.

Full Information

NCT ID

NCT01137695

First Posted

June 3, 2010

Last Updated

October 13, 2011

Sponsor

Cheryl Rosenfeld, DO

Collaborators

Amylin Pharmaceuticals, LLC.

1. Study Identification

Unique Protocol Identification Number

NCT01137695

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Cheryl Rosenfeld, DO

Collaborators

Amylin Pharmaceuticals, LLC.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

pramlintide, glucose, type 2 diabetes mellitus, amylin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Symlin Naive, Usual Dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Symlin Naive, Dose Escalation

Arm Type

Experimental

Arm Description

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

Arm Title

Symlin treated, Usual Dose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Symlin Treated, Dose Escalation

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pramlintide

Intervention Description

120 mcg SQ three times daily for 6 months.

Intervention Type

Drug

Intervention Name(s)

Pramlintide

Intervention Description

360 mcg SQ three times daily for 6 months

Intervention Type

Drug

Intervention Name(s)

Pramlintide

Intervention Description

120 mcg SQ three times daily for 6 months

Intervention Type

Drug

Intervention Name(s)

Pramlintide

Intervention Description

360 mcg SQ three times daily for 6 months

Primary Outcome Measure Information:

Title

Glucose control

Description

A1c Fasting plasma glucose Post-prandial glucose Glycomark

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Weight loss

Description

Weight, BMI, Waist circumference.

Time Frame

6 months

Title

amylin level

Description

does initial blood amylin level correlate with need for higher dose pramlintide?

Time Frame

initial

Title

glucagon level

Description

Does change in glucagon level correlate with glycemic response.

Time Frame

6 months

Title

adverse effects

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnancy or nursing. Inability to provide consent. Unwilling to attend study visits. Unwilling to perform self-monitoring of glucose. Chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening. Investigational drug treatment within 3 months prior to screening. Donation of blood, significant blood loss or transfusion within 3 months of screening. History of acromegaly or Cushing's syndrome. Use of prohibited concomitant medications. Type 1 diabetes mellitus. Acute metabolic complication (hyperosmolar state) <6 months prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheryl Rosenfeld, DO

Organizational Affiliation

North Jersey Endocrine Consultants

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey Rothman, MD

Organizational Affiliation

University Physicians Group Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alan Schorr, DO

Organizational Affiliation

St. Mary Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

North Jersey Endocrine Consultants

City

Denville

State/Province

New Jersey

ZIP/Postal Code

07834

Country

United States

Facility Name

University Physicians Group

City

Staten Island

State/Province

New York

ZIP/Postal Code

10301

Country

United States

Facility Name

St. Mary Medical Center

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

12. IPD Sharing Statement

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

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