A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2608204 Given as Monotherapy or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus

Eli Lilly and Company1 site in 1 country240 target enrollmentSeptember 2011

ConditionsDiabetes Mellitus, Type 2

InterventionsLY2608204 Glimepiride

DrugsLY2608204 Glimepiride

Overview

Phase: Phase 2
Intervention: LY2608204
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Enrollment: 240
Locations: 1
Primary Endpoint: Change from baseline to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c)
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

September 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
•May be treated with:
•Diet and exercise alone or
•Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
•Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
•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

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.

Arms & Interventions

LY2608204

80 to 400 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. The starting dose level depends on the participant's HbA1c level measured at Screening. Administered orally, daily for 12 weeks

Intervention: LY2608204

Glimepiride

1 to 6 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. Administered orally, daily for 12 weeks

Intervention: Glimepiride

Outcomes

Primary Outcomes

Change from baseline to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c)

Time Frame: Baseline, 12 Weeks

Secondary Outcomes

Change from baseline to 12 week endpoint in fasting blood glucose(Baseline, 12 Weeks)
Change from baseline to 12 week endpoint in average Seven Point Self Monitored Blood Glucose(Baseline, 12 Weeks)
Change from baseline to 12 week endpoint for Oral Glucose Tolerance Test (OGTT)(Baseline, 12 Weeks)
Change from baseline to 12 week endpoint in Homa-B: Insulin(Baseline, 12 Weeks)
Change from baseline to 12 week endpoint in Homa-IR: Insulin(Baseline, 12 Weeks)
Change from baseline to 12 week endpoint in Homa-S: Insulin(Baseline, 12 weeks)
Change from baseline to 12 week endpoint in fasting lipids(Baseline, 12 Weeks)
Change from baseline to 12 week endpoint in free fatty acids(Baseline, 12 Weeks)
Change from baseline to 12 week endpoint in body weight(Baseline, 12 Weeks)
Incidence of Hypoglycemic Episodes(Baseline through 12 weeks)
Percentage of participants at each dose level up to 12 weeks(Baseline up to 12 weeks)
Pharmacokinetics: Maximum plasma concentration (Cmax) of LY2608204(pre-dose, up to 12 hours post-dose)
Number of participants with severe hypoglycemic episodes(Baseline through 12 weeks)
Rate of hypoglycemic episodes(Baseline through 12 weeks)
Pharmacokinetics: Area under the curve of concentration-time curve for one dosing interval at steady state (AUC0-tau, ss) of LY2608204(pre-dose, up to 12 hours post-dose)