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NCT01505673 · ClinicalTrials.gov registry record · Phase 4

Adding Liraglutide to High Dose Insulin: Breaking the Cycle

A Phase 4 study of Obesity and Type 2 Diabetes Mellitus, sponsored by Ildiko Lingvay.

Completed
Registry status
Phase 4
Development phase
71
Enrollment target
1
Study location

NCT01505673 is a Phase 4 study of Obesity and Type 2 Diabetes Mellitus that has completed, run by Ildiko Lingvay. The registered enrollment target is 71 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01505673, a Phase 4 study of Obesity and Type 2 Diabetes Mellitus, has completed, sponsored by Ildiko Lingvay.

COMPLETED
Registry status
Phase 4
Development phase
71 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a high-dose insulin regimen (\>1.8 units/kg/day) in patients with uncontrolled (HbA1c \>7.5%) type 2 diabetes mellitus will improve blood sugar control. It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and assesses blood pressure, lipid profile, and liver function. Finally it will look at patient quality of life and safety.

Conditions Studied

Obesity Type 2 Diabetes Mellitus

Interventions

  • DRUG Saline
  • DRUG Liraglutide

Study Locations (1)

Texas

  • UT Southwestern - Dallas

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2012-01
Est. Completion 2016-06
Phase Phase 4

Sponsor

Ildiko Lingvay

1 total trials

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What the Registry Record Tells You About NCT01505673

The ClinicalTrials.gov registry entry for NCT01505673 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (91% lower). The listed sponsor is Ildiko Lingvay, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.

NCT01505673 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT01505673 about?

NCT01505673 is a clinical study titled "Adding Liraglutide to High Dose Insulin: Breaking the Cycle". The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a high-dose insulin regimen (\>1.8 units/kg/day) in patients with uncontrolled (HbA1c \>7.5%) type 2 diabetes mellitus will improve blood sugar control. It also evaluates the effect of liraglutide on liver an...

What is the current status of trial NCT01505673?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2012-01. Estimated completion is 2016-06.

What conditions does trial NCT01505673 study?

This clinical trial studies the following conditions: Obesity, Type 2 Diabetes Mellitus.

What interventions are being tested in trial NCT01505673?

The interventions under investigation include: Saline (DRUG), Liraglutide (DRUG).

Who is sponsoring clinical trial NCT01505673?

This trial is sponsored by Ildiko Lingvay, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01505673 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.