phentermine and Diabetes Mellitus, Type 2 studies

Phentermine: A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity.

Diabetes Mellitus, Type 2: A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

Research Excerpts

Excerpt	Relevance	Reference
"OBJECTIVE To evaluate over 108 weeks the effect of phentermine and topiramate extended release (PHEN/TPM ER) treatment on progression to type 2 diabetes and/or cardiometabolic disease in subjects with prediabetes and/or metabolic syndrome (MetS) at baseline."	9.19	Prevention of type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended release. ( Bohannon, NJ; Day, WW; Garvey, WT; Henry, R; Ryan, DH; Schwiers, M; Toplak, H; Troupin, B, 2014)
" We present the unique case of a Choctaw lady with morbid obesity who has shown a profound response to pharmacotherapy with phentermine."	7.75	A case of profound weight loss secondary to use of phentermine. ( Koch, CA; McDonald, A; Melcescu, E; Uwaifo, GI, 2009)
"OBJECTIVE To evaluate over 108 weeks the effect of phentermine and topiramate extended release (PHEN/TPM ER) treatment on progression to type 2 diabetes and/or cardiometabolic disease in subjects with prediabetes and/or metabolic syndrome (MetS) at baseline."	5.19	Prevention of type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended release. ( Bohannon, NJ; Day, WW; Garvey, WT; Henry, R; Ryan, DH; Schwiers, M; Toplak, H; Troupin, B, 2014)
"In the population of patients with obesity and CVD, the medications orlistat, lorcaserin and liraglutide are considered the most appropriate options for their treatment, in terms of safety."	5.01	Treating obesity in patients with cardiovascular disease: the pharmacotherapeutic options. ( Andrew, CA; Aronne, LJ; Saunders, KH; Shukla, AP, 2019)
"In this paper, data on efficacy, tolerability and safety of FDA-approved pharmacotherapies for obesity (orlistat, phentermine/topiramate extended-release, lorcaserin, bupropion sustained release/naltrexone sustained release and liraglutide) are reviewed, focusing on individuals with type 2 diabetes."	4.98	Pharmacotherapy for obesity in individuals with type 2 diabetes. ( Aronne, LJ; Chukir, T; Saunders, KH; Shukla, AP, 2018)
"The overall use of antiobesity medications remained low over the past 15 years and phentermine was the preferred antiobesity agent."	4.02	Prescribing trends and clinical characteristics of patients starting antiobesity drugs in the United States. ( Kim, DW; Patorno, E; Schneeweiss, S; Suissa, K, 2021)
"Anti-obesity drugs with central mechanisms, such as phentermine and lorcaserin, are available in USA, but not in Europe."	3.96	Obesity Therapy: How and Why? ( Cresci, B; Paccosi, S; Pala, L; Parenti, A; Rotella, CM, 2020)
"We pooled data from 3,040 overweight and obese participants in three randomized controlled trials-CONQUER, EQUIP, and SEQUEL-assessing efficacy and safety of phentermine/topiramate extended release (ER) for weight loss."	3.85	Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. ( Garvey, WT; Guo, F, 2017)
" We present the unique case of a Choctaw lady with morbid obesity who has shown a profound response to pharmacotherapy with phentermine."	3.75	A case of profound weight loss secondary to use of phentermine. ( Koch, CA; McDonald, A; Melcescu, E; Uwaifo, GI, 2009)
"Overall, large weight loss has a major beneficial impact on overweight- and obesity-related complications."	2.82	Benefits of weight loss of 10% or more in patients with overweight or obesity: A review. ( Morton, J; Tahrani, AA, 2022)
"Treatment algorithms for type 2 diabetes recommend weight loss for disease management."	2.79	Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. ( Bohannon, NJ; Dvorak, RV; Garvey, WT; Kushner, RF; Rueger, M; Ryan, DH; Troupin, B, 2014)
"Obesity is highly prevalent worldwide, including among people with chronic kidney disease (CKD)."	2.72	Intensive management of obesity in people with severe chronic kidney disease: A review. ( Harb, H; Nolan, BJ; Song, R; Sumithran, P, 2021)
"Most individuals with type 2 diabetes are overweight, and weight loss for them is an important therapeutic objective."	2.69	Pharmacologic induction of weight loss to treat type 2 diabetes. ( Bantle, JP; Kwong, CA; Raatz, SK; Redmon, JB; Swanson, JE; Thomas, W, 1999)
"While treating obesity, those conditions are also managed."	2.49	Obesity drug therapy. ( Baretić, M, 2013)
"Nearly 90% of individuals with type 2 diabetes mellitus (T2DM) are either overweight or obese, placing them at high risk of microvascular and macrovascular complications."	1.72	Prevalence of Antiobesity Treatment and Weight-Inducing Antihyperglycemic Agents Among Patients With Type 2 Diabetes in the United States. ( Kaur, N; Levin, A; Mainoo, NK; Perez, A, 2022)
"Type 2 diabetes mellitus is one of the significant comorbidities of obesity."	1.37	Obesity and type 2 diabetes mellitus in South Dakota: focused insight into prevalence, physiology and treatment. ( Eid, WE, 2011)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	3 (13.04)	18.2507
2000's	2 (8.70)	29.6817
2010's	11 (47.83)	24.3611
2020's	7 (30.43)	2.80

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.[NCT00796367]	Phase 3	676 participants (Actual)	Interventional	2008-12-31	Completed
A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population With BMI ≥ 35[NCT00554216]	Phase 3	1,267 participants (Actual)	Interventional	2007-11-30	Completed
A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions[NCT00553787]	Phase 3	2,487 participants (Actual)	Interventional	2007-11-30	Completed
A Randomized, Double Blind Multicenter Study to Evaluate the Long-term Safety and Efficacy of VI-0521 Relative to Placebo in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults[NCT00600067]	Phase 2	130 participants (Actual)	Interventional	2008-01-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	percent weight loss (Least Squares Mean)
Placebo	-1.8
VI-0521 Mid	-9.32
VI-0521 Top	-10.5

Intervention	percent participants (Number)
Placebo	30
VI-0521 Mid	75.2
VI-0521 Top	79.3

Intervention	percent weight loss (Least Squares Mean)
Placebo	1.55
VI-0521 Low	5.10
VI-0521 Top	10.92

phentermine and Diabetes Mellitus, Type 2

Research Excerpts

Research

Studies (23)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Percent Weight Change at End of Treatment, Week 108.

Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.

Percent Weight Loss From Baseline to Week 56

Percentage of Subjects With at Least 5% Weight Loss at Week 56

Percent Weight Loss From Baseline to Week 56

Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF

HbA1c Change From Baseline Week 0 to Week 56

Percent Weight Loss From Baseline to Week 56

Reviews

Trials

Other Studies

Authors	Studies
Levin, A	1
Kaur, N	1
Mainoo, NK	1
Perez, A	1
Tahrani, AA	1
Morton, J	1
Dhillon, S	1
Suissa, K	1
Schneeweiss, S	1
Kim, DW	1
Patorno, E	1
Song, R	1
Nolan, BJ	1
Harb, H	1
Sumithran, P	1
Guo, F	1
Garvey, WT	3
Chukir, T	1
Shukla, AP	2
Saunders, KH	2
Aronne, LJ	2
Andrew, CA	1
Paccosi, S	1
Cresci, B	1
Pala, L	1
Rotella, CM	1
Parenti, A	1
Ryan, DH	2
Henry, R	1
Bohannon, NJ	2
Toplak, H	1
Schwiers, M	1
Troupin, B	2
Day, WW	1
Baretić, M	1
Miras, AD	1
le Roux, CW	1
Kalarchian, M	1
Turk, M	1
Elliott, J	1
Gourash, W	1
Kushner, RF	1
Rueger, M	1
Dvorak, RV	1
Alfaris, N	1
Minnick, AM	1
Hopkins, CM	1
Berkowitz, RI	1
Wadden, TA	1
Uwaifo, GI	1
Melcescu, E	1
McDonald, A	1
Koch, CA	1
Eid, WE	1
Apovian, CM	1
Gokce, N	1
DeMeo, MT	1
Mobarhan, S	1
Mikolaitis, S	1
Kazi, N	1
Redmon, B	1
Raatz, S	1
Bantle, JP	3
Redmon, JB	2
Raatz, SK	2
Kwong, CA	2
Swanson, JE	2
Thomas, W	1
Rothman, RB	1

Article	Year
Benefits of weight loss of 10% or more in patients with overweight or obesity: A review. Obesity (Silver Spring, Md.), 2022, Volume: 30, Issue:4 Topics: Anti-Obesity Agents; Diabetes Mellitus, Type 2; Humans; Obesity; Overweight; Phentermine; Quality of	2022
Phentermine/Topiramate: Pediatric First Approval. Paediatric drugs, 2022, Volume: 24, Issue:6 Topics: Adolescent; Adult; Anti-Obesity Agents; Child; Delayed-Action Preparations; Diabetes Mellitus, Type	2022
Intensive management of obesity in people with severe chronic kidney disease: A review. Diabetes, obesity & metabolism, 2021, Volume: 23, Issue:8 Topics: Bariatric Surgery; Diabetes Mellitus, Type 2; Humans; Obesity; Phentermine; Renal Insufficiency, Chr	2021
Pharmacotherapy for obesity in individuals with type 2 diabetes. Expert opinion on pharmacotherapy, 2018, Volume: 19, Issue:3 Topics: Anti-Obesity Agents; Benzazepines; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug Compoun	2018
Treating obesity in patients with cardiovascular disease: the pharmacotherapeutic options. Expert opinion on pharmacotherapy, 2019, Volume: 20, Issue:5 Topics: Anti-Obesity Agents; Benzazepines; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Humans; Lirag	2019
Obesity drug therapy. Minerva endocrinologica, 2013, Volume: 38, Issue:3 Topics: Anti-Obesity Agents; Appetite; Combined Modality Therapy; Comorbidity; Cost-Benefit Analysis; Cyclob	2013
Can medical therapy mimic the clinical efficacy or physiological effects of bariatric surgery? International journal of obesity (2005), 2014, Volume: 38, Issue:3 Topics: Anti-Obesity Agents; Bariatric Surgery; Benzazepines; Benzhydryl Compounds; Blood Glucose; Diabetes	2014
Lifestyle management for enhancing outcomes after bariatric surgery. Current diabetes reports, 2014, Volume: 14, Issue:10 Topics: Appetite Depressants; Bariatric Surgery; Behavior Therapy; Comorbidity; Diabetes Mellitus, Type 2; D	2014
Combination phentermine and topiramate extended release in the management of obesity. Expert opinion on pharmacotherapy, 2015, Volume: 16, Issue:8 Topics: Anti-Obesity Agents; Cardiovascular Diseases; Clinical Trials, Phase II as Topic; Clinical Trials, P	2015

Article	Year
Prevalence of Antiobesity Treatment and Weight-Inducing Antihyperglycemic Agents Among Patients With Type 2 Diabetes in the United States. Clinical therapeutics, 2022, Volume: 44, Issue:3 Topics: Adult; Anti-Obesity Agents; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Liraglutide; Nut	2022
In brief: Semaglutide (Wegovy) for weight loss in children. The Medical letter on drugs and therapeutics, 2023, 02-20, Volume: 65, Issue:1670 Topics: Anti-Obesity Agents; Child; Diabetes Mellitus, Type 2; Glucagon-Like Peptides; Humans; Obesity; Phen	2023
Prescribing trends and clinical characteristics of patients starting antiobesity drugs in the United States. Diabetes, obesity & metabolism, 2021, Volume: 23, Issue:7 Topics: Adult; Anti-Obesity Agents; Cohort Studies; Diabetes Mellitus, Type 2; Female; Humans; Middle Aged;	2021
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Cardiometabolic Disease Staging Predicts Effectiveness of Weight-Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release. Diabetes care, 2017, Volume: 40, Issue:7 Topics: Adult; Anti-Obesity Agents; Blood Glucose; Clinical Trials, Phase III as Topic; Delayed-Action Prepa	2017
Obesity Therapy: How and Why? Current medicinal chemistry, 2020, Volume: 27, Issue:2 Topics: Adolescent; Anti-Obesity Agents; Diabetes Mellitus, Type 2; Europe; Humans; Obesity; Phentermine	2020
A case of profound weight loss secondary to use of phentermine. Journal of the Mississippi State Medical Association, 2009, Volume: 50, Issue:12 Topics: Adult; Appetite Depressants; Body Mass Index; Diabetes Mellitus, Type 2; Dose-Response Relationship,	2009
Obesity and type 2 diabetes mellitus in South Dakota: focused insight into prevalence, physiology and treatment. South Dakota medicine : the journal of the South Dakota State Medical Association, 2011, Volume: Spec No Topics: Adipocytes; Adrenergic Agents; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Metformin; Ob	2011
Obesity and cardiovascular disease. Circulation, 2012, Mar-06, Volume: 125, Issue:9 Topics: Adult; Anti-Obesity Agents; Atrial Fibrillation; Bariatric Surgery; Cardiovascular Diseases; Diabete	2012
Three cases of comprehensive dietary therapy and pharmacotherapy of patients with complex obesity-related diseases. Nutrition reviews, 1997, Volume: 55, Issue:8 Topics: Adult; Aged; Appetite Depressants; Diabetes Mellitus, Type 2; Diet, Reducing; Fatty Liver; Female; F	1997
Valvular heart disease associated with fenfluramine-phentermine. The New England journal of medicine, 1997, Dec-11, Volume: 337, Issue:24 Topics: Appetite Depressants; Diabetes Mellitus, Type 2; Drug Combinations; Female; Fenfluramine; Heart Valv	1997