Phase 3 · Liraglutide

NCT01296412 trial results

A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Change From Baseline in Hemoglobin A1c (A1C) (percent), Baseline and Week 26. Sitagliptin +/- Glimepiride: -1.32; Liraglutide: -1.42.

Participants
653
Status
completed
Completed
2012-02-29
Sponsor
Merck Sharp & Dohme LLC

As posted on ClinicalTrials.gov (NCT01296412), updated at source Jun 9, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01296412 measured first

Change From Baseline in Hemoglobin A1c (A1C)percent · Baseline and Week 26 · least squares mean
Sitagliptin +/- Glimepiriden=269Liraglutiden=253
-1.32(1.06)-1.42(1.04)
Side effects by arm

Side effects in NCT01296412

Percent of participants affected. The most common events the registry lists.

EventSitagliptin +/- GlimepirideLiraglutide
Any serious event5.2%3.7%
Nausea3.1%19.4%
Hypoglycaemia12.6%4.6%
Diarrhoea2.1%10.8%
Vomiting1.8%6.5%
Decreased appetite1.2%6.5%
Secondary outcomes

What else it measured

Change From Baseline in Fasting Plasma Glucose (FPG)mg/dL · Baseline and Week 26 · least squares mean
Sitagliptin +/- Glimepiriden=269Liraglutiden=252
-33.7(46.2)-39.6(40.3)
Percentage of Participants Reaching A1C Goal of <7.0%percentage of participants · Week 26 · number
Sitagliptin +/- Glimepiriden=269Liraglutiden=253
62.872.3
Percentage of Participants Reaching A1C Goal of <6.5%percentage of participants · Week 26 · number
Sitagliptin +/- Glimepiriden=269Liraglutiden=253
33.838.3
The trial

How NCT01296412 was run

This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment.

  • Sitagliptin +/- glimepiride: Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.
  • Liraglutide: Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin \>=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
Who could join the trial

Inclusion criteria * Type 2 diabetes mellitus. * On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%. * Capable of using a liraglutide pen device. Exclusion criteria * History of Type 1 Diabetes mellitus. * Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening. * Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder. * Impaired liver function. * Impaired kidney function. * History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study. * History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment. * Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study. * Participation in another study with an investigational drug or device within 12 weeks prior to screening. * History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site. * Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks. * Surgery within the prior 4 weeks or major surgery planned during the study. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). * User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.

Published papers

Papers from NCT01296412

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.