Phase 4
Completed N=120
The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
Source: ClinicalTrials.gov NCT01966978 ↗Enrolled (actual)
120
Serious AEs
17.3%
Results posted
Oct 2019
Primary outcomePrimary: Mean Change From Randomization in A1c at Week 26 — 3.4; 4.1 Percentage of glycosylated hemoglobin
◆ Published Evidence
Established
53citations · ~8 / year
Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study.
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%).
Linked Publications
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Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Randomization in A1c at Week 26 |
3.4; 4.1 | — |
| SECONDARY Composite End-point |
16; 34 | — |
| SECONDARY Percentage of Participants Reaching Target A1c of <7% at Week 26 |
20; 44 | — |
| SECONDARY Percentage of Participants Reaching Pre-specified "Treatment Failure" Outcome |
16.1; 7.4 | — |
| SECONDARY Mean Change From Randomization in Body Weight |
3.1; -0.6 | — |
| SECONDARY Hypoglycemic Episodes |
66.1; 35.2 | — |
| SECONDARY Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means |
-0.3; -0.9; -0.5; -1.1; -0.3; -0.6 | — |
| SECONDARY Change in Short Form-36 (SF-36) Questionnaire Score |
-0.1; 0.007; 0.04; 0.09 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT01966978) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.