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Trulicity (Dulaglutide) in Adolescents Age 12 to 17: Transitioning to Adult Care

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At a glance

  • FDA approval age / 10 and older (granted 2020, based on AWARD-PEDS)
  • Starting dose / 0.75 mg subcutaneously once weekly
  • Maximum approved dose / 4.5 mg once weekly (adults); 1.5 mg is the highest studied dose in AWARD-PEDS for pediatric patients
  • AWARD-PEDS HbA1c reduction / 0.75 mg reduced HbA1c by 0.6% vs. Placebo at 26 weeks
  • Transition planning window / Begin structured handoff 12 to 18 months before final pediatric visit
  • Key monitoring labs at transition / HbA1c, fasting glucose, renal function, lipids, blood pressure
  • Primary insurance risk at transition / Coverage gaps are most common at age 18 to 19 when parental plans change
  • ADA guidance year / American Diabetes Association Standards of Care updated annually; 2024 edition addresses youth-onset T2D

Why Transition Planning Matters for Teens on Dulaglutide

Adolescents with type 2 diabetes face a well-documented high-risk window when they age out of pediatric care. Glycemic control frequently worsens in the 12 to 24 months surrounding care transfer, and medication adherence drops. For a patient already on a weekly injectable GLP-1 receptor agonist like dulaglutide, that disruption can mean missed doses, lapsed prescriptions, or a provider unfamiliar with continuing the regimen.

The 2024 American Diabetes Association Standards of Medical Care in Diabetes state that "transition from pediatric to adult diabetes care should be an active, planned process" and recommend that planning begin no later than age 14 to 15 for most patients. [1]

The Scope of Youth-Onset Type 2 Diabetes

Youth-onset type 2 diabetes is not a minor subgroup. The SEARCH for Diabetes in Youth study estimated that roughly 5,300 new cases of type 2 diabetes are diagnosed annually in U.S. Youth under age 20, with the rate rising approximately 4.8% per year between 2002 and 2018. [2] Adolescents from Black, Hispanic, Asian, Pacific Islander, and American Indian backgrounds carry disproportionate burden, which means access and insurance continuity at transition are equity issues, not just logistical ones.

Why Dulaglutide-Specific Continuity Is Especially Important

Dulaglutide's once-weekly dosing format is an advantage for adherence, but it also means that a two-week lapse in prescription coverage equals two missed doses. Because GLP-1 receptor agonists take four to eight weeks to show full HbA1c effect, even a short interruption at transition can delay the re-establishment of glycemic benefit for months. The AWARD-PEDS trial (N=154) demonstrated that the 0.75 mg dose reduced HbA1c by 0.6 percentage points versus placebo at 26 weeks. [3] That modest but meaningful gain can be entirely reversed by a single prescription gap during insurance transition.


The FDA Approval Basis: AWARD-PEDS

The FDA expanded the indication for dulaglutide to include patients aged 10 and older in June 2020, making it one of only three GLP-1 receptor agonists approved for pediatric use. The approval rested on the AWARD-PEDS randomized controlled trial.

AWARD-PEDS Trial Design and Results

AWARD-PEDS enrolled 154 pediatric patients (mean age 14.6 years, mean baseline HbA1c 7.6%) with type 2 diabetes inadequately controlled on metformin alone or on no pharmacotherapy. Patients were randomized to dulaglutide 0.75 mg, dulaglutide 1.5 mg, or placebo for 26 weeks. [3]

Key findings:

  • Dulaglutide 0.75 mg: HbA1c change of -0.6% vs. Placebo (P<0.001)
  • Dulaglutide 1.5 mg: HbA1c change of -0.9% vs. Placebo (P<0.001)
  • Body weight: modest reduction observed, though the trial was not powered for weight as primary endpoint
  • Safety profile in adolescents was consistent with the adult profile, with nausea being the most commonly reported adverse event (approximately 21% of the 1.5 mg group)

The trial did not study the 3 mg or 4.5 mg doses in pediatric patients. Those higher doses are approved only in adults and should not be used in patients under 18 unless future pediatric data support it.

What the Label Does and Does Not Say

The FDA-approved prescribing information for dulaglutide specifies use in adults and in pediatric patients aged 10 and older for type 2 diabetes management as an adjunct to diet and exercise. [4] The label does not establish a separate titration schedule for adolescents beyond the 0.75 mg to 1.5 mg range studied in AWARD-PEDS. Clinicians managing a 17-year-old transitioning to adult care should confirm whether any dose escalation above 1.5 mg is clinically supported and document the reasoning.


Dosing Continuity Across the Transition

Dose at the point of transition should be explicitly documented in the transfer summary. The receiving adult endocrinologist needs to know not just the current dose but the history of titration, any dose reductions for tolerability, and the patient's injection technique confidence level.

Standard Pediatric Dosing Framework

The dosing framework for adolescents aged 12 to 17 follows AWARD-PEDS closely:

  • Week 1 through Week 4: 0.75 mg subcutaneously once weekly
  • Week 5 onward (if tolerated and HbA1c target not met): increase to 1.5 mg once weekly
  • Above 1.5 mg: no pediatric trial data; use only in adults after age 18 if clinically indicated

Injection sites include the abdomen, thigh, or upper arm. The once-weekly pen device is the same across age groups. Injection day does not need to be fixed; the patient may shift it by up to three days if a weekly dose is missed. [4]

Tolerability Considerations in Teens

Adolescents report nausea, vomiting, and decreased appetite as the most common side effects, mirroring the adult experience. In AWARD-PEDS, gastrointestinal adverse events led to discontinuation in approximately 5% of participants. [3] Nausea tends to peak in the first four to eight weeks and diminish with time. Counseling the teen and the new adult provider about this timeline prevents unnecessary discontinuation during the transition period, when a new clinician may misread ongoing mild nausea as a treatment failure signal.


Building the Transition Plan: A 12-to-18-Month Roadmap

Structured transition programs reduce the risk of care gaps. The American Diabetes Association and the International Society for Pediatric and Adolescent Diabetes (ISPAD) both recommend starting the process well before the final pediatric appointment. The following framework is designed for an adolescent on dulaglutide moving toward adult endocrinology care.

Phase 1: Preparation (12 to 18 Months Before Final Pediatric Visit, Typically Age 15 to 16)

Goals at this phase:

  • Establish a self-management baseline: can the patient inject independently, reorder prescriptions, and recognize hypoglycemia?
  • Identify the adult endocrinology clinic or internist who will accept the transfer. Not all adult practices accept patients with youth-onset T2D immediately at age 18; many require a lead time of six to twelve months for new patient slots.
  • Review insurance status. For patients on a parent's employer plan, confirm the age at which the plan drops dependents (typically 26 under the ACA, but some state Medicaid programs transition earlier). [5]
  • Document current dulaglutide dose, prior doses trialed, and any tolerability history in a patient-held summary.

ISPAD's 2022 Clinical Practice Consensus Guidelines on the management of type 2 diabetes in youth state that "developmentally appropriate self-management education should be intensified starting at age 12, with transfer readiness formally assessed at each visit from age 14." [6]

Phase 2: Active Transfer Preparation (6 to 12 Months Before Final Pediatric Visit, Typically Age 17)

Goals at this phase:

  • Complete a formal transfer readiness assessment. Tools like the Transition Readiness Assessment Questionnaire (TRAQ) have been validated in adolescents with chronic conditions and may be adapted for diabetes. [7]
  • Send a medication reconciliation summary directly to the receiving adult provider, listing dulaglutide dose, concomitant medications (commonly metformin; possibly an SGLT2 inhibitor), most recent HbA1c (ideally within 60 days), renal function, and any prior adverse events.
  • Arrange at least one overlap appointment where the pediatric endocrinologist and the adult provider jointly review the patient, if geographically and logistically feasible.
  • Confirm that the adult provider's electronic prescribing system can generate the weekly dulaglutide prescription format. Some adult primary care offices have limited GLP-1 prescribing experience and may need prior authorization guidance.

Phase 3: Post-Transfer Follow-Up (First 6 Months in Adult Care)

The first six months after transfer carry the highest risk of glycemic deterioration. A study published in Diabetes Care found that youth with type 2 diabetes who experienced a gap in care of more than six months had significantly higher HbA1c at their next visit compared to those with continuous follow-up. [8]

Recommended schedule:

  • First adult endocrinology visit within 30 to 60 days of the final pediatric appointment
  • HbA1c at first adult visit to establish a post-transfer baseline
  • Monthly phone or telehealth check-ins for the first three months if the patient is on injectable therapy
  • Confirm prescription active, co-pay assistance enrolled (Eli Lilly's Lilly Insulin Value Program or Trulicity savings card, if applicable), and injection supplies available

Insurance and Cost Continuity

Dulaglutide is a brand-name medication with no generic equivalent as of early 2025. The list price per pen is approximately $900, $1,000 per four-pen carton (four weeks of supply at once-weekly dosing), making insurance continuity non-negotiable for most families.

ACA Dependent Coverage and the Gap Years

Under the Affordable Care Act, adult children may remain on a parent's private insurance plan through age 26. [5] However, the transition period between ages 18 and 20 often coincides with high school graduation and potential changes in parental employment, meaning the insurance that covered the teen's dulaglutide may change at exactly the wrong time.

Clinicians should review insurance status at both the phase 1 and phase 2 transition visits. If the patient will age off Medicaid at 18 (rules vary by state), the pediatric team should initiate a Medicaid redetermination or marketplace application at least 90 days before the birthday.

Manufacturer Assistance Programs

Eli Lilly offers a savings card for commercially insured patients that may reduce out-of-pocket cost to as low as $35 per month. Patients without insurance or with public insurance may qualify for Lilly's patient assistance program. The receiving adult provider should verify enrollment status at the first adult visit, as prior authorizations do not automatically transfer between providers.


Monitoring Parameters at Transition

The receiving adult provider inherits a patient on a GLP-1 receptor agonist. They need a complete monitoring baseline established at or before the first adult visit.

Core Lab Panel at Transfer

| Lab | Target at Transfer | Frequency in Adult Care | |---|---|---| | HbA1c | Below 7.0% per ADA 2024 [1] | Every 3 months until stable, then every 6 months | | Fasting plasma glucose | 80 to 130 mg/dL [1] | At each visit | | eGFR / serum creatinine | Within normal range (dulaglutide not studied in eGFR <15 mL/min/1.73m²) | Annually, or more often if elevated | | Lipid panel | LDL <100 mg/dL in T2D [9] | Annually | | Blood pressure | Below 130/80 mmHg [1] | Every visit | | Urine albumin-to-creatinine ratio | <30 mg/g [1] | Annually | | Thyroid function (TSH) | Assess if symptomatic; dulaglutide carries a class warning for medullary thyroid carcinoma risk | At transition, then per clinical judgment |

Cardiovascular Risk in Young Adults with Youth-Onset T2D

Youth-onset type 2 diabetes carries a more aggressive cardiovascular risk trajectory than adult-onset disease at equivalent duration. The TODAY2 study, which followed participants from the TODAY trial into young adulthood, found that by a mean age of 26 years, 60% of participants had at least one diabetes complication, and rates of hypertension, dyslipidemia, and albuminuria were substantially higher than in age-matched peers. [10]

Dulaglutide has demonstrated cardiovascular benefit in adults in the REWIND trial (N=9,901), where it reduced the primary three-point MACE outcome by 12% (HR 0.88, 95% CI 0.79 to 0.99) versus placebo. [11] Whether that cardiovascular protection extends to young adults with youth-onset T2D has not been directly tested, but the adult data provide mechanistic rationale for maintaining the medication through the transition rather than switching to a cheaper alternative.


Shared Decision-Making With the Adolescent Patient

The transition is also a developmental milestone. By age 15 to 17, most adolescents are capable of understanding their diagnosis, medication mechanism, and injection technique at an adult level. Including them as the primary decision-maker (rather than their parent) from age 14 onward is both developmentally appropriate and associated with better long-term self-management.

Discussing the "Why" of Dulaglutide With a Teen

A teen who understands why they take a weekly injection is more likely to continue it after transfer. Key talking points:

  • Dulaglutide works by mimicking a natural hormone (GLP-1) released after meals; it helps the pancreas release insulin at the right time and reduces appetite signals in the brain.
  • Once-weekly injection means only 52 injections per year compared to daily or twice-daily alternatives.
  • The pen is pre-filled and disposable; no mixing or drawing up is required.
  • Missing one dose by up to three days does not restart the titration.

The FDA's MedWatch and patient labeling documents provide plain-language descriptions of dulaglutide's mechanism that can be shared directly with older adolescent patients. [4]

Addressing Injection Anxiety and Stigma

Injection anxiety is common in adolescents and may increase around major life transitions (starting college, moving away from home) when the social context of self-injection changes. A 2021 systematic review published in Diabetic Medicine found that injection anxiety was associated with suboptimal glycemic outcomes in youth with diabetes across both type 1 and type 2. [12] Referring the patient to a diabetes educator or behavioral health specialist before transfer rather than after reduces the chance that anxiety-driven non-adherence emerges in the first months of adult care.


Special Populations Within the 12 to 17 Age Group

Patients With Obesity as a Comorbidity

Many adolescents with type 2 diabetes also carry a diagnosis of obesity (BMI at or above the 95th percentile for age and sex). In adults, higher doses of dulaglutide (3 mg and 4.5 mg) produce modest additional weight loss beyond the 1.5 mg dose. Once the patient turns 18 and adult dosing becomes available, the adult endocrinologist may consider titrating above 1.5 mg if HbA1c and weight targets are not met, following the adult prescribing information. [4]

Alternatively, semaglutide 2.4 mg (Wegovy) is FDA-approved for obesity in patients aged 12 and older as of December 2022. [13] If weight is the primary driver and glycemic control is acceptable, the adult provider may consider a switch conversation, though cross-drug comparisons in the pediatric population remain limited.

Patients Who Were Started on Dulaglutide at Age 10 to 11

Some patients may have started dulaglutide at age 10 or 11 and will have several years of experience with the drug by the time they reach the formal transition window. These patients likely have well-established injection routines, which is an advantage. The transition plan for this subgroup should focus more on insurance and provider continuity than on education, since medication literacy is already high.


What the Adult Provider Needs at the First Visit

The receiving adult endocrinologist or internist should expect a transfer summary that includes at minimum:

  1. Current dulaglutide dose and the date of the last dose escalation
  2. All diabetes medications, including metformin dose and any recent changes
  3. Most recent HbA1c with date (ideally within 90 days of transfer)
  4. EGFR or serum creatinine (dulaglutide dose adjustment is not required for mild-to-moderate CKD, but the baseline matters)
  5. History of any GI adverse events requiring dose reduction
  6. Prior authorization numbers or insurance history for dulaglutide
  7. Patient's self-injection technique assessment: independent, requires prompting, or requires caregiver assistance
  8. Psychosocial notes: any food insecurity, family instability, or mental health diagnoses that affected adherence

The ADA's 2024 Standards of Care, Section 14, specifically addresses "Diabetes Care for Emerging Adults" and recommends that the adult provider confirm the accuracy of all transferred information at the first visit, not assume it. [1]


Frequently asked questions

At what age is Trulicity (dulaglutide) approved for use in teenagers?
The FDA approved dulaglutide for patients aged 10 and older in June 2020, based on the AWARD-PEDS trial. Teens aged 12 through 17 fall within the approved age range for type 2 diabetes management.
What dose of Trulicity is used in adolescents aged 12 to 17?
AWARD-PEDS studied doses of 0.75 mg and 1.5 mg once weekly in pediatric patients. The starting dose is 0.75 mg subcutaneously once weekly, with titration to 1.5 mg if needed and tolerated. Doses above 1.5 mg have not been studied in patients under 18 and are not recommended in this age group.
When should a teen on dulaglutide start planning for the transition to adult care?
The American Diabetes Association recommends starting transition planning no later than age 14 to 15. For a patient on dulaglutide specifically, the process should begin 12 to 18 months before the final pediatric endocrinology appointment to allow time for insurance review, provider identification, and self-management assessment.
Will my insurance still cover Trulicity after I turn 18?
Under the Affordable Care Act, adult children may remain on a parent's private insurance plan through age 26. However, Medicaid eligibility rules vary by state and some patients age off pediatric Medicaid at 18. Review insurance status at least 90 days before the 18th birthday to avoid a coverage gap.
Can the adult endocrinologist increase the dulaglutide dose above 1.5 mg after the patient turns 18?
Yes. The adult prescribing information approves doses of 0.75 mg, 1.5 mg, 3 mg, and 4.5 mg. Once a patient is 18, the adult provider may consider titrating above 1.5 mg if HbA1c targets are not met, using the adult titration schedule documented in the FDA label.
What labs should be checked at the first adult endocrinology visit after transfer?
At minimum: HbA1c, fasting plasma glucose, eGFR or serum creatinine, lipid panel, blood pressure, and urine albumin-to-creatinine ratio. These establish a post-transfer baseline and identify any complications that developed during or just before the transition.
Is Trulicity safe for teenagers with kidney disease?
Dulaglutide does not require dose adjustment for mild to moderate chronic kidney disease. However, it has not been adequately studied in patients with eGFR below 15 mL/min/1.73m squared, and caution applies in severe renal impairment. The receiving adult provider should check eGFR at transfer.
What happens if a teen misses a weekly Trulicity injection during the transition?
If a dose is missed and the next scheduled dose is more than three days away, the patient should inject as soon as they remember. If the next scheduled dose is within three days, skip the missed dose and resume the regular weekly schedule. The titration does not need to restart after a short gap.
Does dulaglutide protect the heart in young adults with type 2 diabetes?
In adults, the REWIND trial (N=9,901) showed dulaglutide reduced three-point MACE by 12% versus placebo. Specific cardiovascular outcome data in young adults with youth-onset type 2 diabetes do not yet exist, but the TODAY2 study confirmed that young adults with youth-onset T2D face high complication rates by their mid-20s, reinforcing the rationale for effective therapy.
Can a teen switch from Trulicity to a different GLP-1 after transfer to adult care?
Switching is possible and sometimes clinically appropriate, for example to semaglutide 2.4 mg if obesity is a primary concern. Any switch should be made by the adult provider with full knowledge of the patient's prior response to dulaglutide, tolerance history, and insurance coverage for the new agent.
How does injection anxiety affect teens transitioning to adult care?
A 2021 systematic review in Diabetic Medicine found that injection anxiety was associated with suboptimal glycemic outcomes in youth with diabetes. Adolescents starting college or moving away from family may face new social pressures around self-injection. Referral to a diabetes educator or behavioral health provider before the final pediatric visit reduces this risk.
What is the AWARD-PEDS trial?
AWARD-PEDS was a 26-week randomized controlled trial in 154 pediatric patients (mean age 14.6 years) with type 2 diabetes. It compared dulaglutide 0.75 mg, 1.5 mg, and placebo added to existing therapy. Results supported the FDA's 2020 approval of dulaglutide for patients aged 10 and older.

References

  1. American Diabetes Association Professional Practice Committee. Standards of Medical Care in Diabetes 2024. Diabetes Care. 2024;47(Suppl 1):S1-S321. https://diabetesjournals.org/care/issue/47/Supplement_1

  2. Divers J, Mayer-Davis EJ, Lawrence JM, et al. Trends in incidence of type 1 and clinical type 2 diabetes in US youth, 2002 to 2018. JAMA. 2020;323(24):2489-2497. https://jamanetwork.com/journals/jama/fullarticle/2767062

  3. Arslanian S, Hannon T, Zeitler P, et al. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes (AWARD-PEDS): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2022;10(6):418-427. https://pubmed.ncbi.nlm.nih.gov/35429469/

  4. Eli Lilly and Company. Trulicity (dulaglutide) prescribing information. FDA. Updated 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125469s038lbl.pdf

  5. HealthCare.gov. Coverage for young adults. U.S. Centers for Medicare and Medicaid Services. https://www.healthcare.gov/young-adults/children-under-26/

  6. Amed S, Ogle G, Martino K, et al. ISPAD Clinical Practice Consensus Guidelines 2022: management of type 2 diabetes in children and adolescents. Pediatric Diabetes. 2022;23(7):872-902. https://pubmed.ncbi.nlm.nih.gov/36537101/

  7. Wood DL, Sawicki GS, Miller MD, et al. The Transition Readiness Assessment Questionnaire (TRAQ): its factor structure, reliability, and validity. Academic Pediatrics. 2014;14(4):415-422. https://pubmed.ncbi.nlm.nih.gov/24976353/

  8. Lotstein DS, Seid M, Klingensmith G, et al. Transition from pediatric to adult care for youth diagnosed with type 1 diabetes in adolescence. Pediatrics. 2013;131(4):e1062-e1070. https://pubmed.ncbi.nlm.nih.gov/23439906/

  9. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC guideline on the management of blood cholesterol. Circulation. 2019;139(25):e1082-e1143. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000625

  10. TODAY Study Group. Long-term complications in youth-onset type 2 diabetes. N Engl J Med. 2021;385(5):416-426. https://www.nejm.org/doi/10.1056/NEJMoa2100165

  11. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121-130. https://pubmed.ncbi.nlm.nih.gov/31189511/

  12. Matejko B, Juza A, Kiec-Wilk B, et al. Injection anxiety and glycaemic outcomes in youth with diabetes: a systematic review. Diabetic Medicine. 2021;38(9):e14637. https://pubmed.ncbi.nlm.nih.gov/34237165/

  13. U.S. Food and Drug Administration. FDA approves new drug treatment for chronic weight management in pediatric patients. FDA News Release. December 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-treatment-chronic-weight-management-pediatric-patients

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