Adding Liraglutide to High Dose Insulin: Breaking the Cycle

Study ID
STU 092011-050

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • UT Southwestern University Hospital—St. Paul
  • Parkland Health & Hospital System

Contact
Anna VanderHeiden
214-648-9439
anna.vanderheiden@phhs.org

Principal Investigator
Ildiko Lingvay

Summary

Study type:
* Single Center (uT Southwestern Medical Center at Dallas, TX)
* Randomized
* Double Blind
* Placebo-Controlled
* Two treatment arms (treatment and control)
* Length of intervention: 6 months
* efficacy and safety trial

after the initial screening all eligible patients will undergo a placebo-only run-in phase for 1-2 weeks, followed by randomization to either the study drug or placebo. Both groups will undergo weekly titration from the initial dose of 0.6 mg/day to the target dose of 1.8 mg/day. evaluations will occur at randomization, 1-, 2-, 4-, and 6-months post-randomization.

endpoints:
Primary endpoint:
1. Change in Hba1c from baseline
Secondary endpoints:
1. Pancreatic triglyceride content
2. Hepatic triglyceride content
3. Fasting and postprandial glucagon levels
4. Beta-cell function
5. Weight
6. Percent reaching aDa Hba1c goal of [Less Than]7%
7. Total daily insulin dose
8. number of injections per day
9. Systolic and diastolic blood pressure
10. Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
11. aLT and aST
12. Quality of Life
13. Treatment satisfaction
14. Compliance with treatment
15. Percent with any treatment related side effects except hypoglycemia
16. Rate of hypoglycemic events (overall and nocturnal)

Participant Eligibility

Inclusion Criteria
1. Type 2 diabetes mellitus
2. Insulin dose of >1.5units/kg/day (represents total daily insulin dose, regardless of formulation, regimen, number of daily shots)
3. HbA1c >= 7.5% and <= 11%
4. Age >= 18
5. Stable comorbidities (no medication changes or exacerbations in >3 months prior to enrolment) 6. Stable dose of all oral hypoglycemics for >= 3 months prior to enrollment
7. Ability to provide informed consent before any trial-related activities