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Condition (MeSH)

Hyperinsulinism

ClinicalTrials.gov lists 4,815 trials for Hyperinsulinism or a narrower condition beneath it. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has the most among industry and government lead sponsors, with 44.

MeSH D006946 Nutritional and Metabolic Diseases C18
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Phase 1 Phase 1 218 Phase 1/2 Phase 1/2 71 Phase 2 Phase 2 335 Phase 2/3 Phase 2/3 73 Phase 3 Phase 3 210 Phase 4 Phase 4 401 Not applicable Not applicable 2,549 Observational Observational 952 Phase 1 Phase 1 218 Phase 1/2 Phase 1/2 71 Phase 2 Phase 2 335 Phase 2/3 Phase 2/3 73 Phase 3 Phase 3 210 Phase 4 Phase 4 401 Not applicable Not applicable 2,549 Observational Observational 952

Trials per phase (log scale)

2 more sections with rows

112 of the 4,815 trials are tagged with Hyperinsulinism itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Hyperinsulinism trials start? (35)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 7 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational
  • Other (Unknown)

Top of scale: 239

1991: 2 trials (Observational 1, Phase 2 1) 1993: 3 trials (Observational 3) 1994: 4 trials (Observational 3, Phase 3 1) 1995: 7 trials (Observational 2, Not applicable 3, Phase 3 1, Phase 2 1) 1996: 4 trials (Observational 3, Not applicable 1) 1997: 6 trials (Observational 2, Not applicable 2, Phase 2/3 1, Phase 1 1) 1998: 8 trials (Observational 1, Not applicable 3, Phase 4 1, Phase 3 2, Phase 2 1) 1999: 9 trials (Observational 3, Not applicable 1, Phase 3 2, Phase 2 2, Phase 1 1) 2000: 20 trials (Observational 5, Not applicable 6, Phase 4 2, Phase 3 2, Phase 2 4, Phase 1/2 1) 2001: 19 trials (Observational 6, Not applicable 6, Phase 4 1, Phase 2 6) 2002: 41 trials (Observational 11, Not applicable 17, Phase 4 5, Phase 3 4, Phase 2 2, Phase 1/2 1, Phase 1 1) 2003: 62 trials (Observational 14, Not applicable 17, Phase 4 13, Phase 3 3, Phase 2/3 1, Phase 2 9, Phase 1/2 2, Phase 1 3) 2004: 101 trials (Observational 15, Not applicable 36, Phase 4 22, Phase 3 5, Phase 2/3 3, Phase 2 13, Phase 1/2 2, Phase 1 5) 2005: 138 trials (Observational 32, Not applicable 44, Phase 4 24, Phase 3 11, Phase 2/3 2, Phase 2 13, Phase 1/2 6, Phase 1 6) 2006: 187 trials (Observational 28, Not applicable 79, Phase 4 28, Phase 3 13, Phase 2/3 4, Phase 2 19, Phase 1/2 4, Phase 1 12) 2007: 182 trials (Observational 41, Not applicable 68, Phase 4 26, Phase 3 9, Phase 2/3 4, Phase 2 22, Phase 1/2 5, Phase 1 7) 2008: 209 trials (Observational 39, Not applicable 85, Phase 4 26, Phase 3 13, Phase 2/3 8, Phase 2 27, Phase 1/2 4, Phase 1 7) 2009: 239 trials (Observational 50, Not applicable 113, Phase 4 20, Phase 3 13, Phase 2/3 5, Phase 2 17, Phase 1/2 6, Phase 1 15) 2010: 188 trials (Observational 41, Not applicable 94, Phase 4 18, Phase 3 10, Phase 2/3 1, Phase 2 9, Phase 1/2 5, Phase 1 10) 2011: 220 trials (Observational 36, Not applicable 105, Phase 4 28, Phase 3 17, Phase 2/3 2, Phase 2 16, Phase 1/2 4, Phase 1 12) 2012: 208 trials (Observational 51, Not applicable 96, Phase 4 21, Phase 3 7, Phase 2/3 7, Phase 2 14, Phase 1 12) 2013: 217 trials (Observational 41, Not applicable 112, Phase 4 20, Phase 3 14, Phase 2/3 1, Phase 2 15, Phase 1/2 3, Phase 1 11) 2014: 230 trials (Observational 46, Not applicable 119, Phase 4 15, Phase 3 11, Phase 2/3 6, Phase 2 17, Phase 1/2 4, Phase 1 12) 2015: 201 trials (Observational 30, Not applicable 114, Phase 4 18, Phase 3 3, Phase 2/3 1, Phase 2 22, Phase 1/2 4, Phase 1 9) 2016: 205 trials (Observational 36, Not applicable 126, Phase 4 15, Phase 3 6, Phase 2/3 5, Phase 2 8, Phase 1 9) 2017: 199 trials (Other 1, Observational 36, Not applicable 121, Phase 4 8, Phase 3 6, Phase 2/3 2, Phase 2 11, Phase 1/2 4, Phase 1 10) 2018: 222 trials (Observational 36, Not applicable 146, Phase 4 18, Phase 3 3, Phase 2/3 3, Phase 2 12, Phase 1/2 2, Phase 1 2) 2019: 220 trials (Observational 35, Not applicable 131, Phase 4 12, Phase 3 12, Phase 2/3 7, Phase 2 13, Phase 1/2 1, Phase 1 9) 2020: 164 trials (Observational 36, Not applicable 98, Phase 4 6, Phase 3 3, Phase 2/3 2, Phase 2 10, Phase 1 9) 2021: 202 trials (Observational 43, Not applicable 131, Phase 4 8, Phase 3 5, Phase 2 8, Phase 1/2 1, Phase 1 6) 2022: 207 trials (Observational 35, Not applicable 137, Phase 4 7, Phase 3 6, Phase 2/3 1, Phase 2 8, Phase 1/2 3, Phase 1 10) 2023: 212 trials (Observational 43, Not applicable 134, Phase 4 10, Phase 3 5, Phase 2/3 1, Phase 2 9, Phase 1/2 4, Phase 1 6) 2024: 226 trials (Observational 47, Not applicable 152, Phase 4 6, Phase 3 4, Phase 2/3 1, Phase 2 5, Phase 1/2 1, Phase 1 10) 2025: 220 trials (Observational 50, Not applicable 128, Phase 4 13, Phase 3 10, Phase 2/3 1, Phase 2 6, Phase 1/2 2, Phase 1 10)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 190
2025 220
2024 226
2023 212
2022 207
2021 202
2020 164
2019 220
2018 222
2017 199

Showing 10 of 35 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 220 trials starting in 2026 and about 220 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 290 trials still running at the 2026-10-09 snapshot; registered median of 21 months across 3,276 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Hyperinsulinism trials in? (10)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 218
Phase 1/2 71
Phase 2 335
Phase 2/3 73
Phase 3 210
Phase 4 401
Not applicable 2,549
Observational 952
Expanded access 5
Unknown 1

How many Hyperinsulinism trials are recruiting? (11)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 141
Recruiting 384
Enrolling by invitation 32
Active, not recruiting 138
Available 3

Showing 5 of 11 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Hyperinsulinism trials? (1)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 44

Which drugs are being tested for Hyperinsulinism? (5)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
HUMAN INSULIN (BIOSYNTHETIC) 24
Insulin LISPRO 20
Calcium/Vitamin D 18
LIRAGLUTIDE 17
Fish Oil 16

Interventions as named in the registry (10)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
1% Metformin 169
Glargine Insulin 120
Exercise 78
Pioglitazone - TZD 55
Rosiglitazone XR 32

Showing 5 of 10 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Hyperinsulinism trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Hospitalization 1,902 4
Invasive Cancer of Any Type 1,403 1
Major Cardiovascular Event 640 1
Gastrointestinal Bleeding 601 1
Myocardial Infarction 530 2

Showing 5 of 10 adverse events.

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Which publications cover Hyperinsulinism? (437)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Reappraising the relationship between hyperinsulinemia and insulin resistance in PCOS. The Journal of endocrinology 2025 Yes
A one-week reduced-carbohydrate diet to mitigate iatrogenic peripheral hyperinsulinemia does not improve insulin sensitivity or endothelial function in a randomized, crossover trial in patients with type 1 diabetes. Cardiovascular diabetology 2025 Yes
Exenatide for diagnosing endogenous hyperinsulinemic hypoglycemia: a randomized placebo-controlled, double-blind, cross-over proof-of-principle study. European journal of endocrinology 2025 Yes
The metabolic potential of inflammatory and insulinaemic dietary patterns and risk of type 2 diabetes. Diabetologia 2024 Yes
Insulin Signaling Through the Insulin Receptor Increases Linear Growth Through Effects on Bone and the GH-IGF-1 Axis. The Journal of clinical endocrinology and metabolism 2023 Yes

Showing 5 of 437 publications.

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Sub-conditions in MeSH (2)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence and rare-disease identity.

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