Double-blind, randomized clinical trial assessing the efficacy and safety of early initiation of sitagliptin during metformin uptitration in the treatment of patients with type 2 diabetes: The CompoSIT-M study

Autor: Raymond L. H. Lam, Keith D. Kaufman, Hideo Makimura, Catherine Ntabadde, Samuel S. Engel, Zachary Zimmer, Guillermo Amorin, Carol Iredale, Edward A. O'Neill, Juan P. Frias, Michael F. Crutchlow
Rok vydání: 2018
Předmět:
Blood Glucose
Male
Time Factors
endocrine system diseases
Endocrinology
Diabetes and Metabolism
Type 2 diabetes
030204 cardiovascular system & hematology
law.invention
0302 clinical medicine
Endocrinology
Randomized controlled trial
law
Medicine
education.field_of_study
Middle Aged
Metformin
Treatment Outcome
Tolerability
Sitagliptin
Drug Therapy
Combination
Female
Original Article
type 2 diabetes
medicine.drug
Adult
medicine.medical_specialty
Population
Urology
030209 endocrinology & metabolism
Placebo
Drug Administration Schedule
sitagliptin
03 medical and health sciences
Double-Blind Method
Internal Medicine
Humans
education
Adverse effect
Aged
Glycated Hemoglobin
Dose-Response Relationship
Drug
business.industry
Sitagliptin Phosphate
nutritional and metabolic diseases
Original Articles
medicine.disease
randomised trial
Diabetes Mellitus
Type 2
business
Zdroj: Diabetes, Obesity & Metabolism
ISSN: 1463-1326
Popis: AIMS To characterize the glycaemic efficacy and safety of initiation of the dipeptidyl peptidase-4 inhibitor sitagliptin during metformin dose escalation in people with type 2 diabetes (T2D) not at glycated haemoglobin (HbA1c) goal on a sub-maximal dose of metformin. MATERIALS AND METHODS Study participants with HbA1c ≥58 mmol/mol and ≤97 mmol/mol (≥7.5% and ≤11.0%) while on 1000 mg/d metformin were randomized to sitagliptin 100 mg once daily or placebo. All were to uptitrate metformin to 2000 mg/d. A longitudinal data analysis model was used to test the primary hypothesis that sitagliptin is superior to placebo when initiated during uptitration of metformin in reducing HbA1c at week 20. [ClinicalTrials.gov Identifier: NCT02791490, EudraCT: 2015-004224-59] RESULTS: A total of 458 participants (mean HbA1c 71.1 mmol/mol [8.7%], T2D duration 6.3 years) were treated. After 20 weeks, the least squares (LS) mean changes from baseline in HbA1c were -12.1 mmol/mol (-14.0, -10.1) (-1.10% [-1.28, -0.93]) and -7.6 mmol/mol (-9.6, -5.6) (-0.69% [-0.88, -0.51]) with sitagliptin and placebo, respectively; the between-group difference in LS mean changes from baseline HbA1c was -4.5 mmol/mol (-6.5, -2.5) (-0.41% [-0.59, -0.23]); P
Databáze: OpenAIRE
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