Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM

This study has been withdrawn prior to enrollment.
(Sponsor could not fund.)
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00732147
First received: August 6, 2008
Last updated: June 2, 2012
Last verified: June 2012
  Purpose

Diabetes affects almost 21 million people in the United States. In this study we will test a drug called Pramlintide(Symlin), and see how it works to lower blood sugar and fat levels after a meal. Lowering high sugar levels and fat levels after a meal is very important in the prevention of the problems that persons with type 2 diabetes often encounter. Hypothesis is that Pramlintide will lower blood sugar and fat levels after a meal.


Condition Intervention
Type 2 Diabetes
Drug: Pramlintide acetate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Pramlintide on Endogenous Production of VLDL-Triglyceride and Glucose in the Post Prandial State in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Endogenous glucose production [ Time Frame: 18 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endogenous VLDL-Triglyceride production [ Time Frame: 18 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Type 2 diabetes patients will receive placebo with 3 meals in experimental period.
Drug: Placebo
120 micrograms given subcutaneously before each meal x 3.
Other Name: placebo
Experimental: 1
Type 2 Diabetes patient will receive Pramlintide with 3 meals in experimental period.
Drug: Pramlintide acetate
120 micrograms given subcutaneously before each meal X 3.
Other Name: Symlin

Detailed Description:

A well recognized and troublesome feature of diabetes management is the exacerbated post prandial glucose elevations following a typical high fat meal. To date the mechanisms driving this increased post prandial glycemia are unclear. Pramlintide is believed to affect intermediary metabolism as well as nutrient absorption. The relative contributions from altered absorption and metabolism to the observed post prandial reductions in plasma glucose and TG concentrations remain uncertain, however. Combinations of radioactive and stable isotope labeling techniques are able to quantify the relevant fluxes of glucose and lipids in vivo in humans and are therefore able to provide quantitative answers to these questions.

Aims:

  1. To determine the effects of Pramlintide on reducing endogenous production of very-low-density-lipoprotein (VLDL)-triglycerides(TG) following a high fat breakfast, lunch and dinner in patients with type 2 diabetes mellitus (T2DM). A triple isotope approach will be used to determine rate of appearance of (VLDL)-triglycerides following breakfast, lunch and dinner.
  2. To compare the relative roles of slowed glucose absorption and reduced endogenous glucose production (glucagonstatic mechanism) in the glucose-lowering effects of Pramlintide in the post prandial state in patients with T2DM.
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 DM study participants will be C-Peptide positive (levels > 0.3 nmol/L)
  • Receiving insulin, metformin and/or sulfonylurea/glitinide.
  • Maintained on stable anti-hypertensive medication.
  • BMI < 52 kg/m2.
  • T2DM for at least 3 months with HBA1C under 10%.

Exclusion Criteria:

  • Receiving TZDs, exenatide, sitagliptin or pramlintide therapy.
  • Receiving medications known to impair gastric emptying, intestinal motility, glucagon release or corticosteroids.
  • Triglyceride levels > 400 mg/dl.
  • BMI > 52 kg/m2.
  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: NCT00732147

Sponsors and Collaborators
University of Maryland
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Stephen N. Davis, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT00732147     History of Changes
Other Study ID Numbers: Pramlintide-080157
Study First Received: August 6, 2008
Last Updated: June 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
triglycerides
endogenous
glucose
production

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 July 28, 2014