Phase 1
Completed N=47
A Study of LY2405319 in Participants With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01869959 ↗Enrolled (actual)
47
Serious AEs
6.5%
Results posted
Mar 2017
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; 1; 0 number of participants
Summary
The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, the study lasted about 2 months for each participant. Participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.
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; 1; 0 | — |
| SECONDARY Change From Baseline to Day 28 in Fasting Glucose |
-3.5; -6.7; -10.5; 3.2 | — |
| SECONDARY 7 Point Self-monitored Blood Glucose (SMBG) |
178.01; 171.13; 183.97; 172.46; 171.03; 167.95 | — |
| SECONDARY Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC) |
12.89; -8.46; -3.22; -28.13 | — |
| SECONDARY Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC) |
-10.07; -10.37; -15.66; -17.98 | — |
| SECONDARY Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC) |
-0.61; 0.07; -1.39; -1.59 | — |
| SECONDARY Change From Baseline to Day 28 in Fasting Lipid Profile |
3.9; -32.5; -31.4; -1.3; -0.1; -26.8 | — |
| SECONDARY Change From Baseline to Day 28 in Body Weight |
-0.7; -1.8; -1.5; -0.2 | — |
| SECONDARY Change From Baseline to Day 28 in Adiponectin |
1850.7; 2907.1; 5648.6; 458.3 | — |
| SECONDARY Change From Baseline to Day 28 in C-Reactive Protein |
-0.6; 0.3; 0.0; 0.4 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319 |
409; 1520; 3410 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319 |
39.9; 105; 247 | — |
| SECONDARY The Number of Participants With Anti-LY2405319 Antibodies |
6; 8; 13; 2 | — |
| SECONDARY Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger |
-1.10; -0.35; -0.27; -2.99; 0.34; 0.04 | — |
| SECONDARY Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score |
-0.06; -0.43; -0.77; 0.74 | — |
| SECONDARY Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score |
1.26; -0.50; 1.82; 2.57 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of T2DM.
- Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen.
- Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral antidiabetic medication (OAM) with an HbA1c value of 6.5% to 9.5%, inclusive.
- Participants on another OAM in addition to metformin therapy may be randomized if removed from treatment of the other OAM ≥14 days prior to study drug administration and fasting blood glucose is ≥145 mg per deciliter (mg/dL) and ≤270 mg/dL.
- Are females not of child-bearing potential due to surgical sterilization or are postmenopausal.
- Have a body mass index (BMI) ≥25 and ≤40.
- Have clinical laboratory test results within normal reference range for the population.
Exclusion Criteria
- Use insulin, thiazolidinediones (TZDs), dipeptidyl peptidase (DPP) IV inhibitors, or exenatide during the 3 months prior to screening.
- Have had more than 1 episode of severe hypoglycemia requiring assistance of another person to administer a resuscitative action within 6 months prior to entry into the study or are currently diagnosed with having hypoglycemia unawareness.
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- Have any abnormality of the electrocardiogram (ECG) that will, in the opinion of the investigator, impair the ability to measure the QT (a corrected QC [QTc] [Bazett's correction] interval >450 milliseconds [msec] for men and >470 msec for women or a PR interval >220 msec are specifically excluded) or have conduction abnormalities that may confound the QTc analysis.
- Have a personal or family history of long QT syndrome, family history of sudden death, personal history of unexplained syncope within the last year; or use prescription or over-the-counter medications known to prolong the QT or QTc interval.
- Have diastolic blood pressure (DBP) ≥95 millimeters of mercury (mm Hg) and/or systolic blood pressure (SBP) ≥160 mm Hg.
- Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to second screening appointment.
- Have current or recent (within the past 3 months) use of gemfibrozil or fenofibrate, niacin, ezetimibe, or bile acid binding resins (for example, cholestyramines). Stable statin therapy of ≥3 months will be allowed.
- Are currently taking central nervous system (CNS) stimulant.
Data sourced from ClinicalTrials.gov (NCT01869959). 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.