NCT03262116 is a Phase 2, PHASE3 clinical trial of Humalog in Type 1 Diabetes Mellitus, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT03262116?

NCT03262116 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT03262116?

Interventions in NCT03262116: Humalog, Novolog, BC222 insulin lispro, Bionic Pancreas.

What condition does NCT03262116 study?

NCT03262116 studies Type 1 Diabetes Mellitus.

Is NCT03262116 still recruiting?

NCT03262116 is currently terminated. Last updated 9 December 2022.

Are results published for NCT03262116?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-12-09 · How we verify

NCT03262116

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas

Terminated Phase 2, PHASE3 Results posted Last updated 9 December 2022

What this trial tests

Phase 2, PHASE3 trial testing Humalog in Type 1 Diabetes Mellitus in 20 participants. Terminated before completion.

Timeline

19 March 2019

Primary endpoint
23 July 2019

23 July 2019

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	19 March 2019
Primary completion	23 July 2019
Estimated completion	23 July 2019
Sites	1 location across United States

Drugs / interventions tested

Humalog (INSULIN LISPRO) — full drug profile →
Novolog (INSULIN ASPART) — full drug profile →
BC222 insulin lispro — full drug profile →
Bionic Pancreas

Conditions studied

Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Continuous Glucose Monitor (CGM) Glucose Primary · 7 days

The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	157.0	± 9.2
Insulin-only Bionic Pancreas With Insulin Lispro	151.4	± 13.1
Insulin-only Bionic Pancreas With Insulin Aspart	151.2	± 13.8

Percentage of Time Spent With CGM Glucose < 54 mg/dl Primary · 7 days

The amount of time the subject spent in the hypoglycemic range \< 54 mg/dl as measured by the continuous glucose monitor during each arm

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	0.30	± 0.53
Insulin-only Bionic Pancreas With Insulin Lispro	0.55	± 0.26
Insulin-only Bionic Pancreas With Insulin Aspart	1.01	± 0.70

Percentage of Time Spent Within Each of the Following Ranges: Secondary · 7 days

The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm

% time CGM glcuose < 50 mg/dl

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	0.20	± 0.42
Insulin-only Bionic Pancreas With Insulin Lispro	0.24	± 0.21
Insulin-only Bionic Pancreas With Insulin Aspart	0.63	± 0.50

% time CGM glcuose < 60 mg/dl

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	0.80	± 0.88
Insulin-only Bionic Pancreas With Insulin Lispro	1.31	± 0.55
Insulin-only Bionic Pancreas With Insulin Aspart	1.85	± 1.05

% time CGM glcuose < 70 mg/dl

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	2.65	± 1.71
Insulin-only Bionic Pancreas With Insulin Lispro	3.59	± 1.71
Insulin-only Bionic Pancreas With Insulin Aspart	4.31	± 1.66

% time CGM glcuose 70-120 mg/dl

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	27.49	± 5.04
Insulin-only Bionic Pancreas With Insulin Lispro	27.20	± 5.53
Insulin-only Bionic Pancreas With Insulin Aspart	30.44	± 5.57

% time CGM glcuose 70-180 mg/dl

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	67.77	± 8.57
Insulin-only Bionic Pancreas With Insulin Lispro	72.16	± 10.34
Insulin-only Bionic Pancreas With Insulin Aspart	70.06	± 10.25

% time CGM glcuose >180 mg/dl

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	29.58	± 7.79
Insulin-only Bionic Pancreas With Insulin Lispro	24.26	± 9.29
Insulin-only Bionic Pancreas With Insulin Aspart	25.63	± 9.02

% time CGM glcuose > 250 mg/dl

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	7.67	± 3.55
Insulin-only Bionic Pancreas With Insulin Lispro	5.21	± 5.24
Insulin-only Bionic Pancreas With Insulin Aspart	7.11	± 6.41

Within Day Coefficient of Variation Secondary · 7 days

A measure of dispersion of glucose values around the mean

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	37.4	± 4.1
Insulin-only Bionic Pancreas With Insulin Lispro	35.5	± 7.8
Insulin-only Bionic Pancreas With Insulin Aspart	38.6	± 7.8

Mean Post Prandial Excursion Secondary · 7 days

Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges.

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	95.06	± 37.49
Insulin-only Bionic Pancreas With Insulin Lispro	103.13	± 47.37
Insulin-only Bionic Pancreas With Insulin Aspart	104.07	± 36.60

Number of Symptomatic Hypoglycemic Events Per Day Secondary · 7 days

The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	0.73	± 0.43
Insulin-only Bionic Pancreas With Insulin Lispro	0.60	± 0.43
Insulin-only Bionic Pancreas With Insulin Aspart	1.02	± 0.67

Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day Secondary · 7 days

The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	12.42	± 11.59
Insulin-only Bionic Pancreas With Insulin Lispro	9.27	± 6.94
Insulin-only Bionic Pancreas With Insulin Aspart	14.00	± 11.95

Total Daily Dose of Insulin Secondary · 7 days

The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm.

Group	Value	95% CI
Insulin-only Bionic Pancreas With BC222 Lispro	0.71	± 0.16
Insulin-only Bionic Pancreas With Insulin Lispro	0.60	± 0.21
Insulin-only Bionic Pancreas With Insulin Aspart	0.61	± 0.25

Sponsor's own description

Subjects will participate in three weeks of the bionic pancreas in the insulin-only configuration. Each week, subjects will use a different rapid acting insulin analog -- Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Humalog

Trials testing the same drug.

NCT06532461 — A Trial of Three- and Seven-days Insulin Infusions Set · NA · recruiting
NCT05571878 — Is Brain Insulin Resistance a Feature of the Biology of Depression in Adolescents · NA · completed
NCT04254380 — Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro · Phase 3 · withdrawn

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03262116 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 9 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03262116.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing