A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT01175811
Last Updated: 2013-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
402 participants
INTERVENTIONAL
2011-02-28
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Premixed Insulin
Twice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension \[LM50\]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension \[LM25\])
Insulin Lispro Premix
Participant dependent dose, administered subcutaneously for 24 weeks
Basal-Bolus
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Insulin Glargine
Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro
Participant dependent dose, administered subcutaneously for 24 weeks
Interventions
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Insulin Lispro Premix
Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Glargine
Participant dependent dose, administered subcutaneously for 24 weeks
Insulin Lispro
Participant dependent dose, administered subcutaneously for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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
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
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
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.
Shanghai, , China
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.
Xi'an, , China
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.
Daegu, , South Korea
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.
Goyang-si, , South Korea
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.
Seoul, , South Korea
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.
Yeongdeungpo-gu, , South Korea
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.
Changhua, , Taiwan
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.
Kuei Shan Hsiang, , Taiwan
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.
Sindian City, , Taiwan
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.
Yong Kung City, , Taiwan
Countries
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References
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Jia W, Xiao X, Ji Q, Ahn KJ, Chuang LM, Bao Y, Pang C, Chen L, Gao F, Tu Y, Li P, Yang J. Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in east Asian patients with type 2 diabetes insufficiently controlled with twice-daily premixed insulin: an open-label, randomised, controlled trial. Lancet Diabetes Endocrinol. 2015 Apr;3(4):254-62. doi: 10.1016/S2213-8587(15)00041-8. Epub 2015 Mar 6.
Other Identifiers
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F3Z-CR-IOQD
Identifier Type: OTHER
Identifier Source: secondary_id
13492
Identifier Type: -
Identifier Source: org_study_id