Using Phentermine and Topiramate to Treat Obesity in Teens with Type 2 Diabetes
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity
This study is testing if a combination of two medications can help teens with type 2 diabetes and obesity lose weight and better manage their diabetes.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04881799 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the effects of the combination medication phentermine/topiramate on body mass index (BMI), insulin sensitivity, and glycemic control in adolescents aged 12 to 20 with type 2 diabetes and obesity. The study includes a 6-month placebo-controlled phase followed by a 6-month open-label extension, comparing the medication's effects against a placebo plus standard treatment. The goal is to determine if this treatment can effectively reduce obesity and improve diabetes management in this population.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 20 with obesity and type 2 diabetes, specifically those with a BMI at or above the 95th percentile for their age and sex.
Not a fit: Patients who are pregnant, lactating, or have recently changed their weight-altering medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing obesity and type 2 diabetes in adolescents.
How similar studies have performed: While the use of phentermine/topiramate has been approved for adults, this specific application in adolescents with type 2 diabetes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 12 to \</= 20 years at study entry * Obesity (BMI \>/= the 95th percentile for age and sex) * HgbA1c \>/= 6.5% at type 2 diabetes diagnosis * Negative diabetes auto-antibodies * English-speaking and Spanish speaking * For participants of child-bearing potential: when sexually active, agreement to use two forms of highly effective contraception (oral contraceptive pill, IUD, implant, and/or condoms) during study participation Exclusion Criteria: * Pregnancy or lactation * Newly-initiated or change in dose of weight altering medication within past 6 months, including SGLT-2 inhibitors and DPP-IV inhibitors, liraglutide 1.8 mg and exenatide ER. * Current or recent (\< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination PHN/TPM, semaglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion) * Current use of sulfonylureas * Previous metabolic/bariatric surgery * Current use of a stimulant medication * History of glaucoma * Current or recent (\< 14 days) use of monoamine oxidase inhibitor or carbonic anhydrase inhibitors * Known hypersensitivity to sympathomimetic amines * Any history of treatment with growth hormone * any history of bulimia nervosa * Major psychiatric disorder as determined by the local medical monitor * Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression or PHQ-9 score of \>/= 15 * Any history of active suicide attempt, a "yes" answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) on the "Suicidal Ideation" portion of the C-SSR, or a "yes" to answer to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C-SSRS * History of suicidal ideation or self-harm within the previous 30 days or a "yes" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "Suicidal Behavior" portion of the C-SSRS and the ideation or behavior occurred within the past month. * Current pregnancy or plans to become pregnant during study participation * Current tobacco use * ALT or AST \>/= 3 times the upper limit of normal * Moderate (Child-Pugh score 7-9) or severe (Child-Pugh score 10-15) * Bicarbonate \<18 mmol/L * Moderate (creatinine clearance \[CrCl\] greater than or equal to 30 and less than 50 mL/min) or severe (CrCl less than 30 mL/min) renal impairment * Any history of seizures • BP for ages 13 and older of \> 130/80 on 3 separate measurements and for age 12 \> 95th percentile on 3 separate measurements * HR ≥120 bpm on 3 separate measurements * History of structural heart defect or clinically significant arrhythmia * Diagnosed monogenic obesity * Any history of cholelithiasis * Any history of nephrolithiasis * Clinically diagnosed hyperthyroidism * Untreated thyroid disorder or TSH below the lower laboratory limit of normal * Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion may put the participant at risk
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Megan Bensignor, MD — University of Minnesota
- Study coordinator: Megan Bensignor, MD
- Email: moberle@umn.edu
- Phone: 612626-2809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.