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Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes

NCT01215955 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1117

Last updated 2014-04-23

Study results available
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Summary

Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin lispro

Administered subcutaneously, up to three times daily for 24 weeks

DRUG

Glargine

Administered subcutaneously, dosage determined by investigator once daily for 24 weeks

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
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Canada
  • Croatia
  • Denmark
  • France
  • Lithuania
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Africa

Study Locations

More Related Trials

Entities

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 NCT01215955 on ClinicalTrials.gov