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A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

NCT01648582 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 774

Last updated 2019-09-18

Study results available
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Summary

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.

Conditions

Interventions

DRUG

Dulaglutide

Administered SC

DRUG

Insulin glargine

Administered SC per dosing titration schedule

DRUG

Metformin

Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

DRUG

Sulfonylureas

Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

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
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • China
  • Mexico
  • Russia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01648582 on ClinicalTrials.gov