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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732147
Recruitment Status : Withdrawn (Sponsor could not fund.)
First Posted : August 11, 2008
Last Update Posted : June 5, 2012
Amylin Pharmaceuticals, LLC.
Information provided by:
University of Maryland, Baltimore

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Pramlintide acetate Drug: Placebo Not Applicable

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.


  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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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

Primary Outcome Measures :
  1. Endogenous glucose production [ Time Frame: 18 hours ]

Secondary Outcome Measures :
  1. Endogenous VLDL-Triglyceride production [ Time Frame: 18 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00732147

Sponsors and Collaborators
University of Maryland, College Park
Amylin Pharmaceuticals, LLC.
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Principal Investigator: Stephen N. Davis, MD Vanderbilt University
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Responsible Party: Stephen N. Davis, University of Maryland, Baltimore Identifier: NCT00732147    
Other Study ID Numbers: Pramlintide-080157
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012
Keywords provided by University of Maryland, Baltimore:
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs