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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/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.
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