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NCT01640834
Pilot Study of the Effects of LY2409021 in Patients With Type 1 Diabetes Mellitus
Phase 1 trial testing LY2409021 in Diabetes Mellitus, Type 1 in 20 participants. Completed in 1 September 2012.
1 September 2012
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 July 2012 |
| Primary completion | 1 September 2012 |
| Estimated completion | 1 September 2012 |
| Sites | 1 location across Germany |
Drugs / interventions tested
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Sponsor
Eli Lilly and Company — full company profile →
Who can join
Adults 18 to 65, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose
Time frame: Baseline (Day 1), Day 2
The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.
Sponsor's own description
This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Abstracts of the 49th EASD (European Association for the Study of Diabetes) Annual Meeting. September 23-27, 2013. Barcelona, Spain.
· 2013 · cited 3× · PMID 23949610 · DOI 10.1007/s00125-013-3012-z
Verify or expand the search:
- PubMed search for NCT01640834
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetes Mellitus, Type 1
Currently open trials in the same condition.
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- NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
- NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
- NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
- NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
- NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
- NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
- NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
- NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
- NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01640834 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
- Last refreshed: 24 March 2018
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/NCT01640834.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing