Phase 1
Completed N=36
A Study of LY2922083 in Healthy Participants and Participants With Diabetes
Source: ClinicalTrials.gov NCT01748552 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Number of Participants With 1 or More Serious Adverse Event(s) (SAEs) — 0; 0; 0; 0 Participants
Summary
The aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
The study consists of two parts. Part A will study healthy participants in up to 3 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 1 or More Serious Adverse Event(s) (SAEs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083 |
25.9; 79.5; 220; 612; 1560; 3270 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of LY2922083 |
2.36; 8.64; 20.3; 66.0; 152; 327 | — |
| SECONDARY Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)] |
7.08; 6.32; -0.02; 12.34; 8.88; 8.40 | — |
| SECONDARY Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)] |
6638.85; 6518.87; 8107.68; 5742.81; 8283.17; 6715.88 | — |
Eligibility Criteria
Inclusion Criteria
For all participants :
- Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
- Have a screening body mass index (BMI) of at least 18.0 kilograms per square meter (kg/m^2)
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
For participants with T2DM:
- Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
- Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening
Exclusion Criteria
For all participants :
- Are currently participating in another clinical study or completed one in the last 30 days
- Are allergic to LY2922083 or other related drugs
- Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
- Have electrocardiogram (ECG) readings that are not suitable for the study
- Have a history of hepatitis or jaundice
- Are infected with hepatitis B
- Are infected with hepatitis C
- Are infected with human immunodeficiency virus (HIV)
- Have donated more than 450 milliliters (mL) of blood in the last 3 months or have donated any blood in the last month
- Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
For participants with T2DM :
- Have had heart disease or stroke within 6 months before entering the study
- Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
- Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
- Have used insulin to control diabetes in the last 1 year
- Show symptoms of high blood sugar (for example, frequent urination, always feeling thirsty, or unexpected weight loss)
Data sourced from ClinicalTrials.gov (NCT01748552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.