Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial

David E. Kelley, George A. Bray, F. Xavier Pi-Sunyer, Samuel Klein, James Hill, John Miles, Priscilla Hollander

Research output: Contribution to journalArticle

213 Citations (Scopus)

Abstract

OBJECTIVE - Weight loss improves glycemic control, lipid profiles, and blood pressure in patients with type 2 diabetes. However, successful long-term weight loss is difficult for these patients, particularly those treated with insulin. The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on weight loss, glycemic control, and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients. RESEARCH DESIGN AND METHODS - This study was a 1-year multicenter, randomized, double-blind, placebo-controlled trial of orlistat (120 mg three times a day) or placebo combined with a reduced-calorie diet in overweight or obese adults (BMI 28-40 kg/m2) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA1c 7.5-12.0%). Outcome measurements included changes in body weight, glycemic control, blood pressure, and serum lipids. RESULTS - After 1 year, the orlistat group lost significantly more weight (-3.89 ± 0.3% of baseline body weight, means ± SE) than the placebo group (-1.27 ± 0.3%, P < 0.001). Orlistat treatment, compared with placebo, produced greater decreases in HbA1c (-0.62 ± 0.08 vs. -0.27 ± 0.08%, P = 0.002), fasting serum glucose (-1.63 ± 0.3 vs. -1.08 ± 0.3 mmol/l, P = 0.02), and the required doses of insulin and other diabetic medications. Orlistat also produced greater improvements than placebo in serum total cholesterol (P = 0.0002) and LDL cholesterol concentrations (P = 0.001) and LDL/HDL ratio (P = 0.01). CONCLUSIONS - Orlistat therapy produces clinically significant weight loss, with improvements in glycemic control and cardiovascular disease risk factors, in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy.

Original languageEnglish (US)
Pages (from-to)1033-1041
Number of pages9
JournalDiabetes Care
Volume25
Issue number6
DOIs
StatePublished - Jun 2002
Externally publishedYes

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Type 2 Diabetes Mellitus
Randomized Controlled Trials
Insulin
Placebos
Weight Loss
Therapeutics
Serum
Blood Pressure
Lipids
Body Weight Changes
Lipase
LDL Cholesterol
orlistat
Fasting
Research Design
Cardiovascular Diseases
Cholesterol
Body Weight
Diet
Weights and Measures

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes : A 1-year randomized controlled trial. / Kelley, David E.; Bray, George A.; Pi-Sunyer, F. Xavier; Klein, Samuel; Hill, James; Miles, John; Hollander, Priscilla.

In: Diabetes Care, Vol. 25, No. 6, 06.2002, p. 1033-1041.

Research output: Contribution to journalArticle

Kelley, David E. ; Bray, George A. ; Pi-Sunyer, F. Xavier ; Klein, Samuel ; Hill, James ; Miles, John ; Hollander, Priscilla. / Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes : A 1-year randomized controlled trial. In: Diabetes Care. 2002 ; Vol. 25, No. 6. pp. 1033-1041.
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abstract = "OBJECTIVE - Weight loss improves glycemic control, lipid profiles, and blood pressure in patients with type 2 diabetes. However, successful long-term weight loss is difficult for these patients, particularly those treated with insulin. The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on weight loss, glycemic control, and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients. RESEARCH DESIGN AND METHODS - This study was a 1-year multicenter, randomized, double-blind, placebo-controlled trial of orlistat (120 mg three times a day) or placebo combined with a reduced-calorie diet in overweight or obese adults (BMI 28-40 kg/m2) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA1c 7.5-12.0{\%}). Outcome measurements included changes in body weight, glycemic control, blood pressure, and serum lipids. RESULTS - After 1 year, the orlistat group lost significantly more weight (-3.89 ± 0.3{\%} of baseline body weight, means ± SE) than the placebo group (-1.27 ± 0.3{\%}, P < 0.001). Orlistat treatment, compared with placebo, produced greater decreases in HbA1c (-0.62 ± 0.08 vs. -0.27 ± 0.08{\%}, P = 0.002), fasting serum glucose (-1.63 ± 0.3 vs. -1.08 ± 0.3 mmol/l, P = 0.02), and the required doses of insulin and other diabetic medications. Orlistat also produced greater improvements than placebo in serum total cholesterol (P = 0.0002) and LDL cholesterol concentrations (P = 0.001) and LDL/HDL ratio (P = 0.01). CONCLUSIONS - Orlistat therapy produces clinically significant weight loss, with improvements in glycemic control and cardiovascular disease risk factors, in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy.",
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T1 - Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes

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AU - Kelley, David E.

AU - Bray, George A.

AU - Pi-Sunyer, F. Xavier

AU - Klein, Samuel

AU - Hill, James

AU - Miles, John

AU - Hollander, Priscilla

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AB - OBJECTIVE - Weight loss improves glycemic control, lipid profiles, and blood pressure in patients with type 2 diabetes. However, successful long-term weight loss is difficult for these patients, particularly those treated with insulin. The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on weight loss, glycemic control, and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients. RESEARCH DESIGN AND METHODS - This study was a 1-year multicenter, randomized, double-blind, placebo-controlled trial of orlistat (120 mg three times a day) or placebo combined with a reduced-calorie diet in overweight or obese adults (BMI 28-40 kg/m2) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA1c 7.5-12.0%). Outcome measurements included changes in body weight, glycemic control, blood pressure, and serum lipids. RESULTS - After 1 year, the orlistat group lost significantly more weight (-3.89 ± 0.3% of baseline body weight, means ± SE) than the placebo group (-1.27 ± 0.3%, P < 0.001). Orlistat treatment, compared with placebo, produced greater decreases in HbA1c (-0.62 ± 0.08 vs. -0.27 ± 0.08%, P = 0.002), fasting serum glucose (-1.63 ± 0.3 vs. -1.08 ± 0.3 mmol/l, P = 0.02), and the required doses of insulin and other diabetic medications. Orlistat also produced greater improvements than placebo in serum total cholesterol (P = 0.0002) and LDL cholesterol concentrations (P = 0.001) and LDL/HDL ratio (P = 0.01). CONCLUSIONS - Orlistat therapy produces clinically significant weight loss, with improvements in glycemic control and cardiovascular disease risk factors, in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy.

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