Clinical trial NCT01175824: Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
Official title: Comparison of Twice-Daily Insulin Lispro Low Mixture Versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine and Metformin and/or Pioglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Insulin LISPRO
Insulin
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Present with type 2 diabetes mellitus
* Have been taking metformin and/or pioglitazone
* Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
* Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5
* Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter \[mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)\], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
* Not pregnant or breastfeeding

Exclusion Criteria:

* Have Type 1 Diabetes
* Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
* Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).
* Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
* 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 had a blood transfusion or have a blood disorder

Primary outcomes:
measure: Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)
timeFrame: Baseline, 24 weeks
measure: Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint
timeFrame: Baseline, 12 weeks
measure: Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks
timeFrame: 24 weeks
measure: Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
timeFrame: 12 weeks, 24 weeks
measure: Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
timeFrame: 12 weeks, 24 weeks
measure: Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
timeFrame: 12 weeks, 24 weeks
measure: Change in Weight From Baseline to 12 Weeks and 24 Weeks
timeFrame: Baseline, 12 weeks, 24 weeks
measure: The Number of Participants With a Hypoglycemic Episodes (Incidence)
timeFrame: Baseline through 24 weeks
measure: Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks
timeFrame: 24 weeks
measure: Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks
timeFrame: 24 weeks
measure: The Rate of Hypoglycemic Episodes
timeFrame: Baseline through 24 weeks
measure: The Number of Participants With Severe Hypoglycemic Episodes
timeFrame: Baseline through 24 weeks
Other outcomes:
Locations:
city: Mar Del Plata
country: Argentina
facility: 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.
city: Ramos Mejia
country: Argentina
facility: 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.
city: Porto Alegre
country: Brazil
facility: 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.
city: São Paulo
country: Brazil
facility: 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.
city: Changzhou
country: China
facility: 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.
city: Harbin
country: China
facility: 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.
city: Alexandria
country: Egypt
facility: 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.
city: Cairo
country: Egypt
facility: 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.
city: Jaipur
country: India
facility: 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.
city: Vishakhapatnam
country: India
facility: 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.
city: Daegu
country: Korea, Republic of
facility: 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.
city: Goyang-Si
country: Korea, Republic of
facility: 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.
city: Kyunggi-Do
country: Korea, Republic of
facility: 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.
city: Seoul
country: Korea, Republic of
facility: 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.
city: Málaga
country: Spain
facility: 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.
city: San Boi De Llobregat
country: Spain
facility: 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.
city: Antalya
country: Turkey
facility: 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.
city: Istanbul
country: Turkey
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: Rojas A, Sposetti G, Gross JL, Barbieri DE, Duan R, Linetzky B, De Lana JM, Stempa O, Rodriguez A. Insulin lispro low mixture twice daily vs basal insulin glargine once daily and prandial insulin lispro once daily as insulin intensification strategies in patients with type 2 diabetes: Latin American subpopulation analysis of a randomized trial. Diabetol Metab Syndr. 2016 Sep 17;8:69. doi: 10.1186/s13098-016-0163-3. eCollection 2016.
citation: Gross JL, Rojas A, Shah S, Tinahones FJ, Cleall S, Rodriguez A. Efficacy and safety of a premixed versus a basal-plus insulin regimen as intensification for type 2 diabetes by timing of the main meal. Curr Med Res Opin. 2016 Jun;32(6):1109-16. doi: 10.1185/03007995.2016.1161609. Epub 2016 Apr 7.
citation: Tinahones FJ, Gross JL, Onaca A, Cleall S, Rodriguez A. Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial. Diabetes Obes Metab. 2014 Oct;16(10):963-70. doi: 10.1111/dom.12303. Epub 2014 May 6.