Effects of taspoglutide on glycemic control and body weight in obese patients with type 2 diabetes (T-emerge 7 study)

Obesity ◽  
2013 ◽  
Vol 21 (2) ◽  
pp. 238-247 ◽  
Author(s):  
Priscilla Hollander ◽  
Ben Lasko ◽  
Anthony H. Barnett ◽  
Monica Bengus ◽  
Linda Kanitra ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Glycemic Control ◽  
Obese Patients

scholarly journals Efficacy and Safety of Ertugliflozin in Patients With Type 2 Diabetes Mellitus and Established Cardiovascular Disease Treated With Metformin and Sulfonylurea

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A331-A331
Author(s):  
Matthew J Budoff ◽  
Timothy M E Davis ◽  
Alexandra G Palmer ◽  
Robert Frederich ◽  
David E Lawrence ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Type 2 Diabetes Mellitus ◽  
Body Weight ◽  
Glycemic Control ◽  
Sglt2 Inhibitor ◽  
Efficacy And Safety

Abstract Introduction: Ertugliflozin (ERTU), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is approved as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM). Aim: As a pre-specified sub-study of the Phase 3 VERTIS CV trial (NCT01986881), the efficacy and safety of ERTU were assessed in patients with T2DM and established atherosclerotic cardiovascular disease (ASCVD) inadequately controlled with metformin and sulfonylurea (SU). Methods: Patients with T2DM, established ASCVD, and HbA1c 7.0–10.5% on stable metformin (≥1500 mg/day) and SU doses as defined per protocol were randomized to once-daily ERTU (5 mg or 15 mg) or placebo. The primary sub-study objectives were to assess the effect of ERTU on HbA1c compared with placebo and to evaluate safety and tolerability during 18-week follow-up. Key secondary endpoints included proportion of patients achieving HbA1c <7%, fasting plasma glucose (FPG), body weight, and systolic blood pressure. Changes from baseline at Week 18 for continuous efficacy endpoints were assessed using a constrained longitudinal data analysis model. Results: Of the 8246 patients enrolled in the VERTIS CV trial, 330 patients were eligible for this sub-study (ERTU 5 mg, n=100; ERTU 15 mg, n=113; placebo, n=117). Patients had a mean (SD) age of 63.2 (8.4) years, T2DM duration 11.4 (7.4) years, estimated glomerular filtration rate 83.5 (17.8) mL/min/1.73 m2, and HbA1c 8.3% (1.0) (67.4 [10.6] mmol/mol). At Week 18, ERTU 5 mg and 15 mg were each associated with a significantly greater least squares mean (95% CI) HbA1c reduction from baseline versus placebo; the placebo-adjusted differences for ERTU 5 mg and 15 mg were –0.7% (–0.9, –0.4) and –0.8% (–1.0, –0.5), respectively (P<0.001). A higher proportion of patients in each ERTU group achieved HbA1c <7% relative to placebo (P<0.001). ERTU significantly reduced FPG and body weight (P<0.001, for each dose versus placebo), but not systolic blood pressure. Adverse events were reported in 48.0%, 54.9%, and 47.0% of patients in the ERTU 5 mg, 15 mg, and placebo groups, respectively. Genital mycotic infections were experienced by significantly higher proportions of male patients who received ERTU 5 mg and 15 mg (4.2% and 4.8%, respectively) versus placebo (0.0%; P≤0.05) and by a numerically, but not significantly, higher proportion of female patients who received ERTU 15 mg (10.3%) compared with placebo (3.8%) (P=0.36). The incidences of symptomatic hypoglycemia were 11.0% (5 mg), 12.4% (15 mg), and 7.7% (placebo), and of severe hypoglycemia 2.0% (5 mg), 1.8% (15 mg), and 0.9% (placebo). Conclusion: Among patients with T2DM and ASCVD, ERTU (5 mg and 15 mg) added to metformin and SU for 18 weeks improved glycemic control (HbA1c and FPG) and reduced body weight, and was generally well tolerated with a safety profile consistent with the SGLT2 inhibitor class.

Abstract 11616: Effect of a Lifestyle Weight Loss Intervention on Visceral Fat and Glycemic Control Among Individuals With and Without Type 2 Diabetes

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Soohyun Nam ◽  
Soohyun Nam ◽  
Devon A Dobrosielski ◽  
Kerry J Stewart
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Body Weight ◽  
Glycemic Control ◽  
Aerobic Fitness ◽  
Visceral Fat ◽  
Subcutaneous Fat ◽  
Moderate Intensity ◽  
Weight Loss Diet

Background: Though a high amount of visceral fat is associated with insulin resistance, which can lead to type 2 diabetes (T2D) and cardiovascular diseases (CVDs), less is known about whether lifestyle modification (weight loss diet and exercise) induced changes in visceral fat are associated with improvements in glycemia. Methods: We randomized 77 individuals aged 35-65 years with T2D or pre-diabetes to 6-months of weight loss diet (D); or D combined with supervised moderate-intensity exercise training (D+E). Study measures were total abdominal, visceral and subcutaneous fat volumes by magnetic resonance imaging, aerobic fitness expressed as VO 2 peak during treadmill testing, body mass index (BMI), and HbA1c levels from blood samples. Results: Of 77 subjects (mean age, 54.8±7.8 years; mean BMI, 34.5 ± 4.7 kg/m 2 , women, 77.9%; Whites-65%, Blacks-34%, Asians-1%), n=37 had T2D and n=40 had pre-diabetes. At 6 months, both D and D+E groups improved from baseline (p<0.05 for all) but did not differ in their changes for body weight (D: -6.04 ± 4.54 kg; D+E: -6.68 ± 4.48 kg, p= 0.61 for the group differences in change), abdominal total fat (D: -101.93 ± 68.67 cm 2 ; D+E:-104.16 ± 72.37 cm 2 , p= 0.92), visceral fat (D:-25.53 ± 39.44 cm 2 ; D+E:,-23.24 ± 35.62 cm 2 , p=0.85), HbA1c (D:0.04 ± 0.46%; D+E:0.03 ± 0.63%, p=0.96), and VO 2 peak (D: 2.26 ± 3.92 ml/kg/min ; D+E:3.71 ± 2.65 ml/kg/min, p=0.11). In a multivariate analysis, adjusting for baseline visceral fat, T2D status, body weight loss and increases in aerobic fitness, a reduction in HbA1c (β=-0.49, p =0.007) was associated with a reduction in visceral fat (R 2 =0.34, p=0.02). Conclusion: The key finding was that diet or diet plus exercise-mediated reductions in visceral fat was associated with reduced HbA1c among individuals with T2D or pre-diabetes. These data contribute to growing body of evidence of the benefits of reducing abdominal obesity, in this case, resulting in better glycemic control in T2D and pre-diabetes.

scholarly journals PDB8 Weight Loss of ≥3% of Body Weight After Initiating New Anti-Diabetic Therapy is Associated With Glycemic Control at 6 Months in Patients With Type 2 Diabetes

2012 ◽  
Vol 15 (7) ◽  
pp. A494
Author(s):  
C. Mcadam-marx ◽  
B.K. Bellows ◽  
G.D. Wygant ◽  
J. Mukherjee ◽  
S. Unni ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Weight Loss ◽  
Body Weight ◽  
Glycemic Control

LOTUS2: The observational study of the effectiveness and safety of insulin glargine (lantus) in the routine clinical practice for the patients with type 2 diabetes mellitus failing to achieve the targeted glycemic control using insulin detemir

2013 ◽  
Vol 59 (5) ◽  
pp. 25-31
Author(s):  
I V Glinkina
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Body Weight ◽  
Glycemic Control ◽  
Insulin Glargine ◽  
Insulin Detemir ◽  
Routine Clinical Practice ◽  
Hba1c Levels

The present study included patients presenting with type 2 diabetes mellitus (DM2) of less than 10 years in duration having the HbA1c levels between 7.0% and 10.0%. They were treated with insulin detemir (once or twice daily) in combination with oral hypoglycemic agents (OHGA) and transferred thereafter to therapy with insulin glargine (Lantus, SoloSTAR) administered once daily. The patients were advised to adjust the dose of insulin glargine in order to achieve the desired fasting blood glucose level (FBGL) below 5.6 mmol/l. The HbA1c levels and FBGL, insulin doses, body weight, frequency of hypoglycemic episodes and adverse reactions were measured within 3 and 6 months after inclusion in the study; simultaneously, the patients and doctors' satisfaction with the treatment was estimated. A total of 915 patients were available for the examination (mean age 57.9±9.2 years, mean duration of DM2 5.9±2.3 years, average BMI 31.0±5.1 kg/m2). The number of the patients presenting with the HbA1c levels below 7% within 6 months after the onset of therapy amounted to 46.5% of the total. During the same period, percentage of the patients experiencing nocturnal and daytime glycemic episodes decreased. No cases of severe hypoglycemia were documented. Moreover, the body weight of the patients somewhat decreased (by 0.9±2.9 kg; p<0.001) by the 6 month. The majority of the patients and their doctors reported the effects of described therapy as "good" or "very good". It is concluded that the substitution of the treatment with insulin detemir in combination with OHGA by therapy with insulin glargine in the patients with DM2 and suboptimal glycemic control under conditions of the routine clinical practice may improve the quality of glycemic control without a substantial body weight gain and with the low frequency of hypoglycemic episodes.

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