A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus Patients

Lilly

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: LY2393910

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01253278

13183

I4B-FW-GPCB (Other Identifier)

Details and patient eligibility

About

The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary purpose of a patient's participation in this study is to help answer the following research question(s), and not to provide treatment for diabetes:

The safety of LY2393910 and any side effects that might be associated with it following 2 weeks of doses
How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks
How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other naturally occurring substances in your body
How daily dosing of LY2393910 affects the cells that produce insulin
Any differences in the above between LY2393910 taken as daily doses in the morning or in the evening

Enrollment

38 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of type 2 diabetes mellitus
Must be on a stable treatment regimen (maintained on diet/exercise therapy with or without metformin) for at least 4 weeks prior to study entry
Have a glycated haemoglobin (HbA1c) value greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen
Weigh 45.0 kg or more
Have a Body Mass Index (BMI) greater than or equal to 18.5 and less than or equal to 40.0 kg/m2
Are willing and able to conduct self-blood glucose monitoring tests

Exclusion criteria

Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving use of an investigational drug or device other than the study drug used in this study, or are concurrently enrolled in any other type of medical research judged not to be compatible with this study
Use of insulin for diabetic control for more than 6 consecutive days within 1 year prior to study entry
Use of thiazolidinediones within 3 months, or other oral anti-diabetics (OADs), apart from metformin, within 1 month prior to study entry. Metformin is acceptable for this study
Previous myocardial infarction, stroke or transient ischaemic event ('TIA'), or clinically significant coronary events or symptoms within 6 months prior to study entry
Subjects who have any evidence of heart insufficiency, hypokalaemia, family history of long-QT-syndrome or are receiving other drugs which extend the QT interval
Clinically significant peripheral vascular disease
Clinical evidence of active diabetic proliferative retinopathy
Known significant autonomic neuropathy
Any patient having experienced a keto-acidotic episode requiring hospitalisation in the last 6 months
Symptomatic hyperglycemia exhibited by significant osmotic symptoms (polyuria or polydipsia), unanticipated weight loss or dehydration
Evidence of hepatitis B and/or positive hepatitis B surface antigen, at screening
Subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
Subjects who are heavy smokers (> 10 cigarettes, or equivalent, per day) or are unable or unwilling to refrain from nicotine during CRU admissions

Exclusion Criteria for EU Site only --

Regular use of known drugs of abuse and/or positive findings on urinary drug screening
Evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies
Evidence of hepatitis C and/or positive hepatitis C antibodies