The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2, Diabetes

In brief

The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c \> 10%).

Key facts

Study ID

NCT01966978

Run by

University of Texas Southwestern Medical Center

People needed

157

Starts

2014-11-01

Expected to finish

2017-12-01

Last updated by the study team

2019-10-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 2 diabetes with confirmed HbA1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.

You may not qualify if…

• Age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
• Type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
• Clinical state requiring inpatient admission/treatment;
• Contraindication or strong cautions to any of the study medications:
• Creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
• History of lactic acidosis (per metformin label)
• Advanced hepatic or cardiac disease (per metformin label)
• Age >80 years (per metformin label)
• Chronic alcohol use (>14 drinks/week)
• History of pancreatitis (per liraglutide label)
• Personal or family history of medullary thyroid cancer or MEN syndrome (per liraglutide label)
• Pregnancy and lactation (per liraglutide label)
• Any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
• Any scheduled elective procedures/surgeries;
• Active infections, including osteomyelitis;
• Not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to Randomization (visit 1)and the week prior to visit 6
• Non English speaking.

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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