Dataset Information

A Post Hoc Analysis of HbA1c, Hypoglycemia, and Weight Change Outcomes with Alogliptin vs Glipizide in Older Patients with Type 2 Diabetes.

ABSTRACT: INTRODUCTION:Adverse events and complications limit the long-term use of current antidiabetic treatment options for patients with type 2 diabetes mellitus (T2DM), particularly for older adults who are often receiving therapy for other comorbid conditions. The aim of this study was to evaluate the benefits of the dipeptidyl peptidase-4 inhibitor, alogliptin, versus glipizide, a sulfonylurea, in achieving glycemic control without the risk of hypoglycemia, weight gain, or both in older patients with T2DM. METHODS:This was an exploratory, post hoc analysis of a global, multicenter, randomized, double-blind, active-controlled study comparing alogliptin and glipizide. Patients (n = 441) aged 65-90 years with glycosylated hemoglobin (HbA1c) 6.5-9.0% who failed on diet and exercise alone or who had inadequately controlled T2DM despite oral antidiabetic monotherapy were recruited from 110 sites across 15 countries. Alogliptin 25 mg (n = 222) or glipizide 5 mg up-titrated to 10 mg (n = 219) was administered once daily for 52 weeks. Composite endpoints of HbA1c ?7.0% coupled with the absence of hypoglycemia and weight gain, or an HbA1c reduction of ?0.5% in the absence of hypoglycemia and weight gain, were then measured. RESULTS:In the primary analysis, least squares mean HbA1c changes from baseline to Week 52 were similar in both the alogliptin and glipizide groups. The proportion of patients achieving HbA1c ?7.0% without hypoglycemia or weight gain was significantly higher for alogliptin versus glipizide (24% vs 13%, p < 0.03). Patients with a baseline HbA1c of <8.0% receiving alogliptin were also more likely to achieve HbA1c ?7.0% without hypoglycemia or weight gain than those receiving glipizide (29% vs 13%, p < 0.03). CONCLUSION:Alogliptin demonstrated similar efficacy to glipizide in lowering HbA1c in older patients with T2DM, but with significantly more patients achieving an HbA1c ?7.0% without hypoglycemia or an increase in body weight. These results particularly apply to patients with baseline HbA1c below 8.0%. FUNDING:The study was sponsored by Takeda Global Research & Development Center, Inc., Deerfield, IL, and Takeda Global Research and Development Centre Ltd., London, United Kingdom.

SUBMITTER: Bron M

PROVIDER: S-EPMC4269655 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Post Hoc Analysis of HbA1c, Hypoglycemia, and Weight Change Outcomes with Alogliptin vs Glipizide in Older Patients with Type 2 Diabetes.

Bron Morgan M Wilson Craig C Fleck Penny P

Diabetes therapy : research, treatment and education of diabetes and related disorders 20141126 2

<h4>Introduction</h4>Adverse events and complications limit the long-term use of current antidiabetic treatment options for patients with type 2 diabetes mellitus (T2DM), particularly for older adults who are often receiving therapy for other comorbid conditions. The aim of this study was to evaluate the benefits of the dipeptidyl peptidase-4 inhibitor, alogliptin, versus glipizide, a sulfonylurea, in achieving glycemic control without the risk of hypoglycemia, weight gain, or both in older pati ...[more]

PMID: 25424968

Similar Datasets

Project description:ObjectivesTo determine associations between postmenopausal change in body weight and incidence of fracture and associations between voluntary and involuntary weight loss and risk of fracture.DesignPost hoc analysis of data from the Women's Health Initiative Observational Study and Clinical Trials.Setting40 clinical centers in the United States.Participants120,566 postmenopausal women, aged 50-79 at baseline (1993-98), followed through 2013 (mean fracture follow-up duration 11 years from baseline).ExposuresAnnualized percentage change in measured body weight from baseline to year 3, classified as stable (<5% change), weight loss (≥ 5%), or weight gain (≥ 5%). Self assessment of whether weight loss was intentional or unintentional. Cox proportional hazards regression models were adjusted for age, race/ethnicity, baseline body mass index (BMI), smoking, alcohol intake, level of physical activity, energy expenditure, calcium and vitamin D intake, physical function score, oophorectomy, hysterectomy, previous fracture, comorbidity score, and drug use.Main outcomesIncident self reported fractures of the upper limbs, lower limbs, and central body; hip fractures confirmed by medical records.ResultsMean participant age was 63.3. Mean annualized percent weight change was 0.30% (95% confidence interval 0.28 to 0.32). Overall, 79,279 (65.6%) had stable weight; 18,266 (15.2%) lost weight; and 23,021 (19.0%) gained weight. Compared with stable weight, weight loss was associated with a 65% higher incidence rates of fracture in hip (adjusted hazard ratio 1.65, 95% confidence interval 1.49 to 1.82), upper limb (1.09, 1.03 to 1.16), and central body (1.30, 1.20 to 1.39); weight gain was associated with higher incidence rates of fracture in upper limb (1.10, 1.05 to 1.18) and lower limb (1.18, 1.12 to 1.25). Compared with stable weight, unintentional weight loss was associated with a 33% higher incidence rates of hip fracture (1.33, 1.19 to 1.47) and increased incidence rates of vertebral fracture (1.16, 1.06 to 1.26); intentional weight loss was associated with increased incidence rates of lower limb fracture (1.11, 1.05 to 1.17) and decreased incidence of hip fracture (0.85, 0.76 to 0.95).ConclusionsWeight gain, weight loss, and intentional weight loss are associated with increased incidence of fracture, but associations differ by fracture location. Clinicians should be aware of fracture patterns after weight gain and weight loss.

Project description:INTRODUCTION:To evaluate the efficacy and safety of dulaglutide 0.75 and 1.5 mg in patients with type 2 diabetes mellitus (T2DM) by baseline glycated hemoglobin (HbA1c)?<?8.5% or???8.5% after 26 weeks of treatment. METHODS:Assessment of the Weekly AdministRation of dulaglutide in Diabetes (AWARD) China 1 (CHN1) study (NCT01644500, n?=?556) included patients on dulaglutide vs. glimepiride who were treatment naïve or on monotherapy but discontinued therapy. AWARD-CHN2 (NCT01648582, n?=?591) patients were on dulaglutide vs. insulin glargine and continued on metformin and/or sulfonylurea. Mean daily dose of glimepiride and insulin glargine was 2.51 mg and 21.0 IU, respectively. Post hoc analyses were conducted based on mixed-model repeated measures using a modified intent-to-treat analysis set with only the Chinese population. Change from baseline in HbA1c and body weight was analyzed by individual study. RESULTS:In the two studies, 70.1% of patients in AWARD-CHN1 and 59.7% in AWARD-CHN2 had baseline HbA1c?<?8.5% (mean HbA1c 7.4% and 7.6%, respectively) and 29.9% in AWARD-CHN1 and 40.3% in AWARD-CHN2 had baseline HbA1c???8.5% (mean HbA1c 9.2% and 9.4%, respectively). In AWARD-CHN1, the HbA1c reductions at 26 weeks with baseline HbA1c?<?8.5% and???8.5%, respectively, were dulaglutide 1.5 mg: -?1.1% and -?2.2%; dulaglutide 0.75 mg: -?0.9% and -?2.0%; glimepiride: -?0.7% and -?1.4%. In AWARD-CHN2, the HbA1c reductions at 26 weeks with baseline HbA1c?<?8.5% and???8.5%, respectively, were dulaglutide 1.5 mg: -?1.2% and -?2.3%; dulaglutide 0.75 mg: -?1.0% and -?1.7%; and insulin glargine: -?0.6% and -?1.7%. Irrespective of baseline HbA1c, body weight decreased with both dulaglutide doses and increased with either glimepiride or insulin glargine at 26 weeks. Dulaglutide demonstrated low incidence of hypoglycemia in both doses in the two trials. Hypoglycemia incidence was generally lower in patients with baseline HbA1c???8.5%. CONCLUSIONS:Dulaglutide demonstrated significantly greater HbA1c reduction with weight loss and lower risk of hypoglycemia compared with active comparators in Chinese patients with T2DM irrespective of baseline HbA1c, with much greater HbA1c reductions in patients with a higher baseline HbA1c. TRIAL REGISTRATION:ClinicalTrials.gov identifier, NCT01644500 and NCT01648582.

Dataset Information

A Post Hoc Analysis of HbA1c, Hypoglycemia, and Weight Change Outcomes with Alogliptin vs Glipizide in Older Patients with Type 2 Diabetes.

Publications

A Post Hoc Analysis of HbA1c, Hypoglycemia, and Weight Change Outcomes with Alogliptin vs Glipizide in Older Patients with Type 2 Diabetes.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets