Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
This study is ongoing, but not recruiting participants.
Sponsor:
Cheryl Rosenfeld, DO
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
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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:
- 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.
Contacts and Locations
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 May 23, 2013