Clinical trial NCT01296412: Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-02-15
Enrollment: 653
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (A1C)
timeFrame: Baseline and Week 26
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline and Week 26
measure: Percentage of Participants Reaching A1C Goal of <7.0%
timeFrame: Week 26
measure: Percentage of Participants Reaching A1C Goal of <6.5%
timeFrame: Week 26
Other outcomes:
Locations:
Study officials:
References:
citation: Charbonnel B, Steinberg H, Eymard E, Xu L, Thakkar P, Prabhu V, Davies MJ, Engel SS. Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial. Diabetologia. 2013 Jul;56(7):1503-11. doi: 10.1007/s00125-013-2905-1. Epub 2013 Apr 19.