8 research outputs found
A randomized, controlled trial of 3.0 mg of liraglutide in weight management
BACKGROUND Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagonlike peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS At baseline, the mean (卤SD) age of the patients was 45.1卤12.0 years, the mean weight was 106.2卤21.4 kg, and the mean BMI was 38.3卤6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4卤7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8卤6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.)
Characterization of Lactobacillus salivarius alanine racemase: short-chain carboxylate-activation and the role of A131
Ontology-based prediction of cochlear implantation outcome using cross-modal plasticity analysis
Open shear fractures at depth in anticlines: insights from the Kuqa foreland thrust belt, Tarim Basin
Plio-Quaternary thin-skinned tectonics along the crustal front flexure of the southern Central Andes: a record of the regional stress regime or of local tectonic-driven gravitational processes?
A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
BACKGROUND: Obesity is a chronic disease with serious health consequences, but
weight loss is difficult to maintain through lifestyle intervention alone.
Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential
benefit for weight management at a once-daily dose of 3.0 mg, injected
subcutaneously.
METHODS: We conducted a 56-week, double-blind trial involving 3731 patients who
did not have type 2 diabetes and who had a body-mass index (BMI; the weight in
kilograms divided by the square of the height in meters) of at least 30 or a BMI
of at least 27 if they had treated or untreated dyslipidemia or hypertension. We
randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous
injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244
patients); both groups received counseling on lifestyle modification. The
coprimary end points were the change in body weight and the proportions of
patients losing at least 5% and more than 10% of their initial body weight.
RESULTS: At baseline, the mean (卤SD) age of the patients was 45.1卤12.0 years, the
mean weight was 106.2卤21.4 kg, and the mean BMI was 38.3卤6.4; a total of 78.5% of
the patients were women and 61.2% had prediabetes. At week 56, patients in the
liraglutide group had lost a mean of 8.4卤7.3 kg of body weight, and those in the
placebo group had lost a mean of 2.8卤6.5 kg (a difference of -5.6 kg; 95%
confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward
imputation). A total of 63.2% of the patients in the liraglutide group as
compared with 27.1% in the placebo group lost at least 5% of their body weight
(P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body
weight (P<0.001). The most frequently reported adverse events with liraglutide
were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the
patients in the liraglutide group and in 5.0% of the patients in the placebo
group.
CONCLUSIONS: In this study, 3.0 mg of liraglutide, as an adjunct to diet and
exercise, was associated with reduced body weight and improved metabolic control.
(Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839
ClinicalTrials.gov number, NCT01272219.)
Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes.
BACKGROUND:
A fixed-ratio combination of the basal insulin analogue insulin degludec and the glucagon-like peptide-1 (GLP-1) analogue liraglutide has been developed as a once-daily injection for the treatment of type 2 diabetes. We aimed to compare combined insulin degludec-liraglutide (IDegLira) with its components given alone in insulin-naive patients.
METHODS:
In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1路8 mg per day). IDegLira and insulin degludec were titrated to achieve a self-measured prebreakfast plasma glucose concentration of 4-5 mmol/L. The primary endpoint was change in HbA1c after 26 weeks of treatment, and the main objective was to assess the non-inferiority of IDegLira to insulin degludec (with an upper 95% CI margin of 0路3%), and the superiority of IDegLira to liraglutide (with a lower 95% CI margin of 0%). This study is registered with ClinicalTrials.gov, number NCT01336023.
FINDINGS:
1663 adults (mean age 55 years [SD 10], HbA1c 8路3% [0路9], and BMI 31路2 kg/m(2) [4路8]) were randomly assigned, 834 to IDegLira, 414 to insulin degludec, and 415 to liraglutide. After 26 weeks, mean HbA1c had decreased by 1路9% (SD 1路1) to 6路4% (1路0) with IDegLira, by 1路4% (1路0) to 6路9% (1路1) with insulin degludec, and by 1路3% (1路1) to 7路0% (1路2) with liraglutide. IDegLira was non-inferior to insulin degludec (estimated treatment difference -0路47%, 95% CI -0路58 to -0路36, p<0路0001) and superior to liraglutide (-0路64%, -0路75 to -0路53, p<0路0001). IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8路8 vs 19路7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3路6%). We noted no clinically relevant differences between treatments with respect to standard safety assessments, and the safety profile of IDegLira reflected those of its component parts. The number of confirmed hypoglycaemic events per patient year was 1路8 for IDegLira, 0路2 for liraglutide, and 2路6 for insulin degludec. Serious adverse events occurred in 19 (2%) of 825 patients in the IDegLira group, eight (2%) of 412 in the insulin degludec group, and 14 (3%) of 412 in the liraglutide group.
INTERPRETATION:
IDegLira combines the clinical advantages of basal insulin and GLP-1 receptor agonist treatment, resulting in improved glycaemic control compared with its components given alone