Phase 1
Completed N=66
A Study of Multiple Doses of LY2922470 in Participants With Diabetes
Source: ClinicalTrials.gov NCT01867216 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
Summary
The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 |
4220; 11,600; 25,100; 81,400; 21,000; 50,700 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 |
723; 1540; 2750; 8200; 1510; 3150 | — |
| SECONDARY Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 |
1.50; 2.50; 2.75; 4.00; 2.00; 2.50 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 |
-0.38; -0.54; -0.43; -0.24; -0.16; -0.34 | — |
| SECONDARY Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 |
21.7; -93; 70.4; -499; -205; -531 | — |
| SECONDARY Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 |
665; 147; 793; -159; -740; 1230 | — |
Eligibility Criteria
Inclusion Criteria
- Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
- Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
- Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
- Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
Exclusion Criteria
- Are currently participating in another clinical study or completed one in the last 30 days
- 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
- Are infected with hepatitis B or hepatitis C
- Are infected with human immunodeficiency virus (HIV)
- Have donated blood equal to or more than 500 mL within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
Data sourced from ClinicalTrials.gov (NCT01867216). 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.