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A Study to Evaluate the Effect of LY2189265 on the Speed at Which Food and Drink Leaves the Stomach in Patients With Type 2 Diabetes Mellitus

NCT01215968 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2014-10-07

Study results available
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Summary

The primary purpose of this Study is to help answer the following research question(s).

* How does LY2189265 affect gastric emptying (the speed at which food and drink leaves the stomach) in patients with Type 2 diabetes?
* How does LY2189265 affect how the body handles metformin (a drug used to treat Type 2 diabetes)?
* Is LY2189265 safe and are any side effects associated with it?

The study will be participant-blind in Week 1, and participant- and investigator-blind from Week 2 through Week 5.

Each participant will receive placebo on Week 1 and once-weekly doses of LY2189265 or Placebo on Weeks 2 to 5. Participants taking metformin for the treatment of Type 2 Diabetes Mellitus (T2DM) will continue taking metformin as part of the study.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BIOLOGICAL

LY2189265

1.5 mg administered subcutaneously

DRUG

Placebo

Administered subcutaneously

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

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 NCT01215968 on ClinicalTrials.gov