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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 26

Percentage 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

Page last updated: August 23, 2015

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