Adding Liraglutide to High Dose Insulin: Breaking the Cycle

Part of paid clinical trials in Dallas, Texas.

Sponsor
Ildiko Lingvay
Study ID
NCT01505673
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
  • Saline — DRUG
    Placebo injection of 1.8mg saline once daily for 6-months

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Dec 2017
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
71 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutide
  • Placebo Comparator: Saline injection

Primary Outcome Measure

Glycemic Control Measured by HbA1c [ Time Frame: 6-months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT SouthwesternDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Obesity / overweightType 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
UT Southwestern· Dallas, TX

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