Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01027871




Registration number
NCT01027871
Ethics application status
Date submitted
8/12/2009
Date registered
9/12/2009
Date last updated
8/06/2018

Titles & IDs
Public title
A Study for Patients With Type 2 Diabetes
Scientific title
A Phase 2 Study of LY2605541 Compared With Insulin Glargine in the Treatment of Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
I2R-MC-BIAC
Secondary ID [2] 0 0
12149
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 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 - LY2605541
Treatment: Drugs - insulin glargine

Experimental: LY2605541 Dosing Algorithm 1 - Participants took both LY2605541 and their pre-study insulin for first several days

Experimental: LY2605541 Dosing Algorithm 2 - Participants took only LY2605541 with first dose doubled

Active comparator: Insulin glargine -


Treatment: Drugs: LY2605541
subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks

Treatment: Drugs: insulin glargine
subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Percentage of Participants With HbA1c <7.0% and =6.5% at Week 12 Endpoint
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Percentage of Participants With HbA1c <7.0% and HbA1c =6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Daily Basal Insulin Dose at Week 2 and Week 12
Timepoint [6] 0 0
Week 2 and Week 12
Secondary outcome [7] 0 0
Percentage of Participants With Hypoglycemia From Baseline Through Week 12
Timepoint [7] 0 0
Baseline through Week 12
Secondary outcome [8] 0 0
Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12
Timepoint [8] 0 0
Baseline through Week 12
Secondary outcome [9] 0 0
Percentage of Participants With Antibody Status Change From Baseline to Week 12 and Week 16
Timepoint [9] 0 0
Week 12 and Week 16
Secondary outcome [10] 0 0
Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12
Timepoint [10] 0 0
Baseline and Week12
Secondary outcome [11] 0 0
Pharmacokinetics - Drug (LY2605541) Concentration at Steady State (Css) at Week 12 Endpoint
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
Change From Baseline in HbA1c at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [13] 0 0
Baseline, Week 12
Secondary outcome [14] 0 0
Percentage of Participants With HbA1c <7.0% and =6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [14] 0 0
Week 12
Secondary outcome [15] 0 0
Percentage of Participants Who Did Not Experience a Hypoglycemic Episode During Treatment With HbA1c <7.0% and HbA1c =6.5% at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [16] 0 0
Week 12
Secondary outcome [17] 0 0
Daily Basal Insulin Dose at Week 2 and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [17] 0 0
Week 2 and Week 12
Secondary outcome [18] 0 0
Percentage of Participants With Hypoglycemia From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [18] 0 0
Baseline through Week 12
Secondary outcome [19] 0 0
Rate of Hypoglycemia Per 30 Days From Baseline Through Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [19] 0 0
Baseline through Week 12
Secondary outcome [20] 0 0
Glycemic Variability in Fasting Blood Glucose at Baseline and Week 12 - Subgroup Analysis of LY2605541 Dosing Algorithms
Timepoint [20] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
* Type 2 diabetes mellitus (T2DM) for at least 1 year
* At least 18 years of age
* Using metformin and/or sulfonylurea(s) with once daily glargine or NPH for at least 3 months prior to the study. Prestudy dose requirements: insulin dose maximum 1.0 unit/kilogram/day (U/kg/day). Oral antihyperglycemic medications (OAMs): Metformin dose at least 1500 milligram/day (mg/day) and/or sulfonylurea dose at least half the maximum daily dose specified in the local package insert. OAM doses stable for 6 weeks prior to the study.
* Hemoglobin A1c (HbA1c) less than or equal to 10.5% before randomization
* Body Mass Index (BMI) 19 to 45 kilogram/square meter (kg/m²)
* Capable and willing to prepare and inject insulin with a syringe while continuing to use the prestudy OAMs, monitor own blood glucose; complete the study diary; be receptive to diabetes education; comply with study visits and receive telephone calls between visits
* Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up visit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Long-term use of short- or rapid-acting or premixed insulin within the 6 months before the study. Short-term insulin therapy or occasional use are permitted
* Use of any glucose-lowering medications not allowed by the inclusion criteria in the 3 months before entry into the study
* Use of prescription or over-the-counter medications to promote weight loss within 3 months before entry into the study
* Current participation in a weight loss program, or plans to do so during the study
* Treatment with any antibody-based therapy within 6 months prior to the study
* Use of chronic (>14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
* More than 1 episode of severe hypoglycemia within 6 months prior to the study, or currently diagnosed with hypoglycemia unawareness
* 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
* Liver disease
* History of renal transplantation, current renal dialysis, or creatinine >2.0 milligram/deciliter (mg/dL) (177 micromole/Liter [µmol]/L)
* Cardiac disease with a marked impact on physical functioning
* Clinically significant electrocardiogram (ECG) abnormalities at screening
* Malignancy other than basal cell or squamous cell skin cancer
* Fasting triglycerides >500 mg/dL
* Known diabetic autonomic neuropathy
* Known hypersensitivity or allergy to study insulin or its excipients
* Blood transfusion or severe blood loss within 3 months prior to entry into the study or known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology
* Irregular sleep/wake cycle
* Women who are breastfeeding

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 2
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
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
289
Recruitment in Australia
Recruitment state(s)
NSW,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. - Coffs Harbour
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. - Keswick
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. - Ringwood East
Recruitment hospital [4] 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. - Fremantle
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
5035 - Keswick
Recruitment postcode(s) [3] 0 0
3135 - Ringwood East
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Idaho
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Hungary
State/province [5] 0 0
Gyula
Country [6] 0 0
Hungary
State/province [6] 0 0
Veszprem
Country [7] 0 0
Poland
State/province [7] 0 0
Bialystok
Country [8] 0 0
Poland
State/province [8] 0 0
Lublin
Country [9] 0 0
Puerto Rico
State/province [9] 0 0
Hato Rey
Country [10] 0 0
Puerto Rico
State/province [10] 0 0
Manati
Country [11] 0 0
Puerto Rico
State/province [11] 0 0
San Juan
Country [12] 0 0
Romania
State/province [12] 0 0
Cluj-Napoca
Country [13] 0 0
Romania
State/province [13] 0 0
Iasi
Country [14] 0 0
Romania
State/province [14] 0 0
Targu Mures
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Arkhangelsk
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Moscow
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Rostov-On-Don
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Saint Petersburg
Country [19] 0 0
Spain
State/province [19] 0 0
Alicante
Country [20] 0 0
Spain
State/province [20] 0 0
Dos Hermanas
Country [21] 0 0
Spain
State/province [21] 0 0
Malaga

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

Ethics approval
Ethics application status

Summary
Brief summary
Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.
Trial website
https://clinicaltrials.gov/study/NCT01027871
Trial related presentations / publications
Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
Bergenstal RM, Rosenstock J, Bastyr EJ 3rd, Prince MJ, Qu Y, Jacober SJ. Lower glucose variability and hypoglycemia measured by continuous glucose monitoring with novel long-acting insulin LY2605541 versus insulin glargine. Diabetes Care. 2014;37(3):659-65. doi: 10.2337/dc12-2621. Epub 2013 Nov 6.
Bergenstal RM, Rosenstock J, Arakaki RF, Prince MJ, Qu Y, Sinha VP, Howey DC, Jacober SJ. A randomized, controlled study of once-daily LY2605541, a novel long-acting basal insulin, versus insulin glargine in basal insulin-treated patients with type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2140-7. doi: 10.2337/dc12-0060. Epub 2012 Oct 9.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01027871