Status:
COMPLETED
A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.
Eligibility Criteria
Inclusion
- Present with type 2 diabetes mellitus
- Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry
- Have Haemoglobin A1c (HbA1c) \>7.0% and \<12.0%
Exclusion
- Within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications
- Are pregnant or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
- Are women who are breastfeeding.
- Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night).
- Do not regularly consume three meals per day.
- Have a body mass index \>35 kilogram per square meter (kg/m\^2).
- Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study.
- Have cardiac disease with a functional status that is Class III or IV
- Have a history of renal or liver disease
- Have used less than or equal to 20 Units per day (U/day) of insulin during the past 90 days for more than 14 days (accumulated).
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT01175811
Start Date
February 1 2011
End Date
November 1 2012
Last Update
December 18 2013
Active Locations (14)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beijing, China, 100730
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guangzhou, China, 510515
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kunming, China, 650032
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nanjing, China, 210109