Overview

A Study in Patients With Type 2 Diabetes

Status:
Withdrawn
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The study is designed to see if once daily oral dosing of LY2608204 will help control diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will also help to determine the safety of the medication and the most useful doses of the medication.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Glimepiride
Globalagliatin
Criteria
Inclusion Criteria:

- Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial

- May be treated with:

1. Diet and exercise alone or

2. Diet and exercise in combination with a stable dose of metformin for at least 3
months before Screening or

3. Diet and exercise in combination with a stable dose of sulfonylurea or
meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or

4. Diet and exercise in combination with stable doses of metformin and sulfonylurea
or metformin and meglitinides for at least 3 months before Screening and have had
diabetes for at least 6 years

- Must have an Hemoglobin A1c value between 7% and 10%

- Must have a body mass index (BMI) between 20 and 40 kg/m2

- Must have stable weight during the 3 months prior to Screening (weight change not to
exceed 5 kg (11 lb))

- If female, you must not be able to get pregnant

- Must be well motivated, capable, and willing to complete study required glucose
monitoring and instruction

Exclusion Criteria:

- Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or
meglitinide during the 3 months prior to Screening

- Have a gastrointestinal disease that significantly impacts gastric emptying or
motility or have undergone gastric bypass or gastric banding surgery

- Have had more than one episode of severe hypoglycemia within 6 months prior to entry
into the study, or are currently diagnosed as having hypoglycemia unawareness or have
had 2 or more emergency room visits or hospitalizations due to poor glucose control in
the past 6 months

- Are currently taking or have taken within the last 2 months, prescription or over-the
counter medications which affect body weight

- Have cardiac disease with functional status that is New York Heart Association [NYHA]
Class II, III, or IV or a history of myocardial infarction, unstable angina, or
decompensated congestive heart failure in the past 6 months.

- Have poorly controlled hypertension, history of malignant hypertension, evidence of
renal artery stenosis and/or evidence of labile blood pressure including symptomatic
postural hypotension. Doses of antihypertensive medications must be stable for 30 days
before randomization

- Have a QTcB (Bazett's-corrected QT interval) interval greater than 450 msec for men or
greater than 470 for women at Screening or any personal history of ventricular
tachycardia or unexplained syncope

- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis,
or significantly elevated liver blood tests

- Are currently receiving renal dialysis, have a serum creatinine greater than 2.0 mg/dL
(177 μmol/L) or a calculated creatinine clearance of less than 60 ml/min or in
patients being treated with metformin, have other known contradictions to metformin
use including, but not limited to, a serum creatinine above (or creatinine clearance
below) what is approved in the metformin product label

- Have fasting state hypertriglyceridemia (defined as greater than 5.65 mmol/L, 500
mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must
be stable for 30 days prior to randomization.

- Are receiving chronic (for more than 2 weeks) systemic glucocorticoid therapy
(excluding topical or inhaled preparations) or have received such therapy within 4
weeks immediately prior to Randomization

- Have an active or untreated malignancy or have been in remission from a clinically
significant malignancy (other than basal or squamous cell skin cancer, in situ
carcinomas of the cervix, or in situ prostate cancer) for less than 5 years

- Have a history of seizure disorder

- Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)

- Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with
a narrow therapeutic index