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WithdrawnNCT00732147Updated Jul 22, 2021

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

An interventional study of Pramlintide acetate and Placebo in Type 2 Diabetes, sponsored by University of Maryland, Baltimore. Withdrawn. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-22.

Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Sponsor could not fund.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Type 2 Diabetes

Keywords

  • triglycerides
  • endogenous
  • glucose
  • production
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    2

    Type 2 diabetes patients will receive placebo with 3 meals in experimental period.

    Drug: Placebo

  • Experimental
    1

    Type 2 Diabetes patient will receive Pramlintide with 3 meals in experimental period.

    Drug: Pramlintide acetate

Interventions

  • DrugPramlintide acetate

    120 micrograms given subcutaneously before each meal X 3.

    Also known as: Symlin

  • DrugPlacebo

    120 micrograms given subcutaneously before each meal x 3.

06

What researchers measure

Primary outcomes

  1. Endogenous glucose production

    Time frame: 18 hours

Secondary outcomes

  1. Endogenous VLDL-Triglyceride production

    Time frame: 18 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00732147
Lead sponsor
University of Maryland, Baltimore
Collaborators
Amylin Pharmaceuticals, LLC.
Responsible party
Stephen N. Davis, MBBS (Chair, Department of Medicine; Director, General Clinical Research Center; Director, Clinical and Translational Sciences Institute, University of Maryland, Baltimore) — Principal investigator
First posted
Aug 11, 2008
Start date
Apr 2009
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Jul 22, 2021

Study contacts

Stephen N. Davis, MD
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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