NCT00732147

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 11, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2 years

First QC Date

August 6, 2008

Last Update Submit

July 18, 2021

Conditions

Type 2 Diabetes

Keywords

triglyceridesendogenousglucoseproduction

Outcome Measures

Primary Outcomes (1)

  • Endogenous glucose production

    18 hours

Secondary Outcomes (1)

  • Endogenous VLDL-Triglyceride production

    18 hours

Study Arms (2)

2

PLACEBO COMPARATOR

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

Drug: Placebo

1

EXPERIMENTAL

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

Drug: Pramlintide acetate

Interventions

Pramlintide acetateDRUG

120 micrograms given subcutaneously before each meal X 3.

Also known as: Symlin
1
PlaceboDRUG

120 micrograms given subcutaneously before each meal x 3.

2

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

pramlintide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Stephen N. Davis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Medicine; Director, General Clinical Research Center; Director, Clinical and Translational Sciences Institute

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 11, 2008

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 22, 2021

Record last verified: 2021-07