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NCT00804986
A 12-Week,Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients With Type 2 Diabetes Mellitus
Phase 2 trial testing LY2428757 in Diabetes Mellitus, Type 2 in 247 participants. Completed in 1 January 2010.
1 January 2010
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 247 |
| Start date | 1 December 2008 |
| Primary completion | 1 January 2010 |
| Estimated completion | 1 January 2010 |
| Sites | 60 locations across United States, Austria, Germany, India, Mexico, Puerto Rico, Romania, South Africa |
Drugs / interventions tested
- LY2428757 — full drug profile →
- Placebo
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Eli Lilly and Company — full company profile →
Who can join
Adults 18 to 70, any sex, with Diabetes Mellitus, Type 2. 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.
-
Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint
Time frame: baseline, 12 weeks
LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.
Sponsor's own description
A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00804986
- 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 2
Currently open trials in the same condition.
- NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
- NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
- NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
- NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · 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 NCT00804986 (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 Eli Lilly and Company
- Last refreshed: 12 July 2011
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/NCT00804986.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing