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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00548808




Registration number
NCT00548808
Ethics application status
Date submitted
22/10/2007
Date registered
24/10/2007
Date last updated
15/09/2010

Titles & IDs
Public title
A Study for Type 2 Diabetic Patients
Scientific title
Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication
Secondary ID [1] 0 0
F3Z-CR-IOPH
Secondary ID [2] 0 0
11541
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Insulin lispro low mixture
Treatment: Drugs - Insulin glargine
Treatment: Drugs - Insulin lispro

Experimental: Insulin lispro low mixture - Insulin lispro low mixture (1, 2 or 3 daily injections)

Active Comparator: Insulin glargine - Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)


Treatment: Drugs: Insulin lispro low mixture
Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.

Treatment: Drugs: Insulin glargine
Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks

Treatment: Drugs: Insulin lispro
Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
Timepoint [1] 0 0
Baseline, 48 weeks
Secondary outcome [1] 0 0
Change in Hemoglobin A1c (HbA1c) Over Time
Timepoint [1] 0 0
Baseline, 16 Weeks, 32 Weeks, 48 Weeks
Secondary outcome [2] 0 0
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Timepoint [2] 0 0
16 weeks, 32 weeks, 48 weeks
Secondary outcome [3] 0 0
7-point Self-monitored Blood Glucose Profiles
Timepoint [3] 0 0
Baseline, 16 weeks, 32 weeks, 48 weeks
Secondary outcome [4] 0 0
Change From Baseline in Postprandial Blood Glucose Over Time - The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.
Timepoint [4] 0 0
Baseline, 16 weeks, 32 weeks, 48 weeks
Secondary outcome [5] 0 0
Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
Timepoint [5] 0 0
16 weeks, 32 weeks, 48 weeks
Secondary outcome [6] 0 0
Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
Timepoint [6] 0 0
16 weeks, 32 weeks, 48 weeks
Secondary outcome [7] 0 0
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
Timepoint [7] 0 0
baseline, 48 weeks
Secondary outcome [8] 0 0
Safety: Number of Participants With Serious and Non-Serious Adverse Events - Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.
Timepoint [8] 0 0
baseline through 48 weeks

Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus

- Receiving oral antihyperglycemic medications (including metformin) without insulin
injection in the last 90 days

- Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%

- Willing to receive insulin injection while continuing to take the prestudy oral
antihyperglycemic medications

- Able to perform self monitoring of blood glucose
Minimum age
30 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Are taking any other glucose-lowering agents other than metformin, sulfonylurea or
Thiazolidinedione (Pioglitazone)

- Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in
the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks

- Have a body mass index greater than 35 kg/m2

- History or presence of kidney disease

- Have cardiac disease (Class III or IV)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
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. - Daw Park
Recruitment hospital [2] 0 0
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. - East Ringwood
Recruitment hospital [3] 0 0
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. - Nedlands
Recruitment postcode(s) [1] 0 0
5041 - Daw Park
Recruitment postcode(s) [2] 0 0
3135 - East Ringwood
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Belem
Country [2] 0 0
Brazil
State/province [2] 0 0
Campinas
Country [3] 0 0
Brazil
State/province [3] 0 0
Curitiba
Country [4] 0 0
Brazil
State/province [4] 0 0
Fortaleza
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Prince Edward Island
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Guang Zhou
Country [12] 0 0
China
State/province [12] 0 0
Shanghai
Country [13] 0 0
India
State/province [13] 0 0
Aligarh
Country [14] 0 0
India
State/province [14] 0 0
Bangalore
Country [15] 0 0
India
State/province [15] 0 0
Coimbatore
Country [16] 0 0
India
State/province [16] 0 0
Mumbai
Country [17] 0 0
India
State/province [17] 0 0
Trivandrum
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Kyunggi-Do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Mexico
State/province [20] 0 0
Mexico City
Country [21] 0 0
Mexico
State/province [21] 0 0
Monterrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily
injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections)
on lowering the blood sugar level
Trial website
https://clinicaltrials.gov/show/NCT00548808
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications