Trial · NCT01358981
A Study of LY2881835 in Healthy People and People With Diabetes
NCT01358981, Phase 1, Completed, Eli Lilly and Company; results first posted 2019-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LY2881835 in Healthy People and People With Diabetes. Trials, record NCT01358981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01358981
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY2881835 in Healthy People and People With Diabetes
- NCT number
- NCT01358981
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- LY2881835, Placebo
- First posted
- 2011-05-24
- Last updated
- 2019-06-19
- Results first posted
- 2019-06-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Adverse Effects | Baseline to study completion up to 3 months | Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug. |
| Secondary | Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835 | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours \[AUC(0-24 hours)\] is provided. |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835 | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided. |
| Secondary | Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835 | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided. |
| Secondary | Glucose Area Under the Effective Concentration Curve (AUEC) | Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose | Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours. |
| Secondary | Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC) | Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose | Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours. |
| Secondary | C-Peptide Area Under the Effective Concentration Curve (AUEC) | Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose | C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinically Significant Adverse Effects | Baseline to study completion up to 3 months | All enrolled participants who received study drug. | participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835 | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received. | nanograms*hour/milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835 | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835 | Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose | All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received. | hours | MEDIAN |
| SECONDARY | Glucose Area Under the Effective Concentration Curve (AUEC) | Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose | All participants who received study drug and had evaluable glucose data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding glucose measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received. | milligrams*hour/deciliter (mg*hr/dL) | MEAN |
| SECONDARY | Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC) | Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose | All participants who received study drug and had evaluable GLP-1 data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding GLP-1 measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received. | picomoles*hour/liter (pmol*h/L) | MEAN |
| SECONDARY | C-Peptide Area Under the Effective Concentration Curve (AUEC) | Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose | All participants who received study drug and had evaluable C-Peptide data. Each participant in group Part B, Study Periods (SP) 1, 2, 3-8.4 mg LY2881835 was dosed and had corresponding C-Peptide measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received. | picomoles*hour/liter (pmol*h/L) | MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Adverse Effects | Part A - Placebo | 0 | participants | ||
| Number of Participants With Clinically Significant Adverse Effects | Part A - 0.5 mg LY2881835 | 0 | participants | ||
| Number of Participants With Clinically Significant Adverse Effects | Part A - 1.5 mg LY2881835 | 1 | participants | ||
| Number of Participants With Clinically Significant Adverse Effects | Part A - 4.5 mg LY2881835 | 0 | participants | ||
| Number of Participants With Clinically Significant Adverse Effects | Part A - 8.4 mg LY2881835 | 0 | participants | ||
| Number of Participants With Clinically Significant Adverse Effects | Part B - Placebo | 1 | participants | ||
| Number of Participants With Clinically Significant Adverse Effects | Part B - 8.4 mg LY2881835 | 2 | participants | ||
| Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835 | Part A - 0.5 mg LY2881835 | 54.8 | Geometric Coefficient of Variation 39 | nanograms*hour/milliliter (ng*hr/mL) | |
| Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835 | Part A - 1.5 mg LY2881835 | 125 | Geometric Coefficient of Variation 47 | nanograms*hour/milliliter (ng*hr/mL) | |
| Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835 | Part A - 4.5 mg LY2881835 | 340 | Geometric Coefficient of Variation 31 | nanograms*hour/milliliter (ng*hr/mL) |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow91
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Cohort 1: Part A (Healthy): Sequence 1 | 2 | |
| Period 1 | STARTED | Cohort 1: Part A (Healthy): Sequence 2 | 2 | |
| Period 1 | STARTED | Cohort 1: Part A (Healthy): Sequence 3 | 2 | |
| Period 1 | STARTED | Cohort 1: Part A (Healthy): Sequence 4 | 2 | |
| Period 1 | STARTED | Cohort 2: Part B (T2DM): Sequence 1 | 3 | |
| Period 1 | STARTED | Cohort 2: Part B (T2DM): Sequence 2 | 3 | |
| Period 1 | STARTED | Cohort 2: Part B (T2DM): Sequence 3 | 3 | |
| Period 1 | Received at Least 1dose of Study Drug | Cohort 1: Part A (Healthy): Sequence 1 | 2 | |
| Period 1 | Received at Least 1dose of Study Drug | Cohort 1: Part A (Healthy): Sequence 2 | 2 | |
| Period 1 | Received at Least 1dose of Study Drug | Cohort 1: Part A (Healthy): Sequence 3 | 2 |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 participant flowAdverse events119
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Part A - Placebo | 0 | 9 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part A - 0.5 mg LY2881835 | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part A - 1.5 mg LY2881835 | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part A - 4.5 mg LY2881835 | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part A - 8.4 mg LY2881835 | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part B - Placebo | 1 | 9 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Part B - 8.4 mg LY2881835 | 0 | 9 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Part A - Placebo | 0 | 9 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Part A - 0.5 mg LY2881835 | 0 | 6 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Part A - 1.5 mg LY2881835 | 0 | 6 | 0 |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A - Placebo | 0 | 9 |
| Total, all-cause mortality | Part A - 0.5 mg LY2881835 | 0 | 6 |
| Total, all-cause mortality | Part A - 1.5 mg LY2881835 | 0 | 6 |
| Total, all-cause mortality | Part A - 4.5 mg LY2881835 | 0 | 6 |
| Total, all-cause mortality | Part A - 8.4 mg LY2881835 | 0 | 6 |
| Total, all-cause mortality | Part B - Placebo | 0 | 9 |
| Total, all-cause mortality | Part B - 8.4 mg LY2881835 | 0 | 9 |
| Total, other adverse events | Part A - Placebo | 3 | 9 |
| Total, other adverse events | Part A - 0.5 mg LY2881835 | 3 | 6 |
| Total, other adverse events | Part A - 1.5 mg LY2881835 | 3 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01358981
GET https://conductscience.org/api/trials/v1/NCT01358981/results?page=2