The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study (SIMPLE)
Diabetes Mellitus, Type 2, Diabetes
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Insulin, Insulin, Long-Acting, Insulin, Short Acting, Detemir, Liraglutide, GLP-1, Glucagon Like Peptide, Metformin, Uncontrolled Diabetes, Elevated A1c, Incretins
Eligibility Criteria
Inclusion Criteria:
1. 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Control: Metformin, Insulin Detemir, Insulin Aspart
Metformin, insulin determir, Liraglutide
Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician
Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)