The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2; Diabetes
Intervention: Metformin (Drug); Detemir (Drug); Liraglutide (Drug); Insulin Aspart (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): Ildiko Lingvay, Principal Investigator, Affiliation: UT Southwestern Medical Center
Overall contact: Marconi Abreu, MD, Phone: 214-648-8479, Email: marconi.abreu@phhs.org
Summary
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%).
Clinical Details
Official title: The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, Parallel-group, Intention to Treat Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Composite end-point
Secondary outcome: Mean change from randomization in A1c at week 26Percentage of patients reaching target A1c of <7% at week 26 Percentage of patients reaching pre-specified "treatment failure" outcome Mean change from randomization in body weight Percentage of patients who lost 5% or more of body weight from randomization Hypoglycemic episodes Percentage of patients experiencing any hypoglycemic episode Diabetes Quality of Life (DQOL)questionnaire score Short Form-36 (SF-36) questionnaire score Number of daily injections Health care cost, total Health care cost, diabetes-related Number of titration events by healthcare professional Number of titration events by patient Healthcare provider time during scheduled office (minutes/visit) Healthcare provider time, unscheduled (total minutes) Compliance with pharmacologic therapy Change in LDL cholesterol from baseline to week 26 Change in triglycerides from baseline 7-point glucose profiles over 2 consecutive days
Detailed description:
The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment
regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled
(HbA1c>10%) type 2 diabetes. The investigators will compare the two regimens with respect to
efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on
patient quality of life, treatment burden, physician time, as well as healthcare related
cost. The investigators hypothesize that at 26 weeks from randomization the two treatment
regimens will have similar percentage of patients reaching A1c levels <7. 0%, while more
patients on the GLP-1 plus basal insulin strategy will achieve the composite end point of
A1c levels <7. 0% without severe hypoglycemia or significant weight gain.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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:
1. 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;
2. Type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
3. Clinical state requiring inpatient admission/treatment;
4. Contraindication or strong cautions to any of the study medications:
1. Creatinine above 1. 4 mg/dl for women and 1. 5 mg/dl for men (per metformin label)
2. History of lactic acidosis (per metformin label)
3. Advanced hepatic or cardiac disease (per metformin label)
4. Age >80 years (per metformin label)
5. Chronic alcohol use (>14 drinks/week)
6. History of pancreatitis (per liraglutide label)
7. Personal or family history of medullary thyroid cancer or MEN syndrome (per
liraglutide label)
8. Pregnancy and lactation (per liraglutide label)
5. Any serious or unstable medical condition as it would interfere with treatment
assignment as well as outcome measurement;
6. Any scheduled elective procedures/surgeries;
7. Active infections, including osteomyelitis;
8. 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
9. Non English speaking.
Locations and Contacts
Marconi Abreu, MD, Phone: 214-648-8479, Email: marconi.abreu@phhs.org
UT Southwestern Medical Center, Dallas, Texas 02720, United States; Recruiting Marconi Abreu, MD, Phone: 214-648-8479, Email: marconi.abreu@phhs.org Laura Golici, BA, Phone: 214-648-2515, Email: laura.golici@utsouthwestern.edu Ildiko Lingvay, MD, Principal Investigator Marconi Abreu, MD, Sub-Investigator
Additional Information
Starting date: November 2014
Last updated: May 26, 2015
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