A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus

NCT01029795 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2011-12-02

Study results available
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Summary

The purpose of this study is to help answer the following research question(s):

* To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks.
* To evaluate the safety of LY2599506 in participants with diabetes.
* To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
* To determine how much LY2599506 should be given to participants.
* To determine if LY2599506 has an effect on a participant's weight.

The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow up period.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

LY2599506

Administered orally (po), twice daily (BID) prior to morning and evening meals for 12 weeks

DRUG

Glyburide

Administered po, BID daily prior to morning and evening meals for 12 weeks

DRUG

Placebo

Matching placebo capsules administered po, BID prior to morning and evening meals for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern Time (UTC/GMT - 5hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Australia
  • Austria
  • Czechia
  • Germany
  • Israel
  • Russia
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01029795 on ClinicalTrials.gov