Brief Summary

Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

138

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach

2 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

January 1, 2010

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed

7.3 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed

Last Updated

April 17, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

January 12, 2010

Results QC Date

March 17, 2018

Last Update Submit

March 17, 2018

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
It is the Avg. of the 8-point SMBG profiles, BG of morning fasting, midday \& evening pre-meal, 2-hour postprandial after each of the 3 main meals, bedtime, 0300 hours. Least squares (LS) mean of daily Avg. BG is from mixed-model repeated measures (MMRM), which includes fixed effects of treatment (LY2605541, Glargine); Treatment Sequence; treatment period; dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline Hemoglobin \[HbA1c\] group); visit; visit and treatment interaction; a random effect for participant.
Week 8 of each treatment period

Secondary Outcomes (11)

Change From Baseline in Daily Average Blood Glucose (Avg. BG) at Week 8 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
Baseline, Week 8 of each treatment period
Change From Baseline in Hemoglobin (HbA1c) at Week 8 Endpoint of Period I
Baseline, Week 8 (Period I)
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint of Period I
Week 8 (Period I)
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 8 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment (Period I)
Week 8 (Period I)
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 8 Endpoint
Week 8 of each treatment period
+6 more secondary outcomes

Study Arms (2)

LY2605541 First, Then Insulin Glargine

EXPERIMENTAL

Participants received LY2605541 for 8 weeks, followed by insulin glargine for 8 weeks.

Drug: LY2605541Drug: Insulin glargine

Insulin Glargine First, Then LY2605541

ACTIVE COMPARATOR

Participants received insulin glargine for 8 weeks, followed by LY2605541 for 8 weeks.

Drug: LY2605541Drug: Insulin glargine

Interventions

LY2605541DRUG

Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.

Insulin Glargine First, Then LY2605541LY2605541 First, Then Insulin Glargine

Insulin glargineDRUG

Administered subcutaneously every morning with dose titration based on blood glucose measures for 8 weeks in each of 2 study periods.

Insulin Glargine First, Then LY2605541LY2605541 First, Then Insulin Glargine

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes mellitus (T1DM) for at least 1 year and using insulin glargine for at least 6 months with a maximum daily dose of 1 unit per kilogram (U/kg).
Hemoglobin A1c (HbA1c) of no greater than 10.5% before randomization
Body mass index (BMI) 19 to 45 kilogram per square meter (kg/m²)
Capable and willing to prepare and inject insulin with a syringe, monitor own blood glucose, complete the study diary, be receptive to diabetes education, comply with study requirements, and receive telephone calls during treatment
Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up

You may not qualify if:

Twice daily use of insulin glargine within 30 days prior to the study
Use of any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 3 months prior to the study
Use of an insulin pump
More than 1 episode of severe hypoglycemia within 3 months prior to the study, or currently diagnosed as having hypoglycemia unawareness
or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
Known hypersensitivity or allergy to any of the study insulins or their excipients
Blood transfusion or severe blood loss within 3 months prior to 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
Pregnant or intend to become pregnant during the study
Women who are breastfeeding
Use of prescription or over-the-counter medications to promote weight loss within 3 months prior to the study
Current participation in a weight loss program or plans to do so during the study
Use of chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
Cardiac disease with a marked impact on physical functioning
Clinically significant electrocardiogram (ECG) abnormalities at screening
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (13)

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.

Chula Vista, California, 91911, United States

Location

Atlanta, Georgia, 30309, United States

Location

Idaho Falls, Idaho, 83404, United States

Location

Topeka, Kansas, 66606, United States

Location

Metairie, Louisiana, 70006, United States

Location

Baltimore, Maryland, 21204, United States

Location

Minneapolis, Minnesota, 55416, United States

Location

Austin, Texas, 78731, United States

Location

Dallas, Texas, 75230, United States

Location

Renton, Washington, 98057, United States

Location

Holon, 22100, Israel

Location

Petah Tikva, 49451, Israel

Location

Tel Litwinsky, 52661, Israel

Location

Related Publications (4)

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.
PMID: 15855602BACKGROUND
Qu Y, White RD, Ruberg SJ. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials. Ther Innov Regul Sci. 2023 May;57(3):521-528. doi: 10.1007/s43441-022-00491-0. Epub 2022 Dec 21.
PMID: 36542287DERIVED
Rosenstock J, Blevins TC, Bergenstal RM, Morrow LA, Qu Y, Jacober SJ. Reduction in short-acting insulin requirement accompanies improved glycemic control with basal insulin peglispro compared with insulin glargine in patients with type 1 diabetes. J Diabetes. 2016 Jan;8(1):166-9. doi: 10.1111/1753-0407.12332. Epub 2015 Nov 17. No abstract available.
PMID: 26278063DERIVED
Rosenstock J, Bergenstal RM, Blevins TC, Morrow LA, Prince MJ, Qu Y, Sinha VP, Howey DC, Jacober SJ. Better glycemic control and weight loss with the novel long-acting basal insulin LY2605541 compared with insulin glargine in type 1 diabetes: a randomized, crossover study. Diabetes Care. 2013 Mar;36(3):522-8. doi: 10.2337/dc12-0067. Epub 2012 Nov 27.
PMID: 23193209DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

LY2605541Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 14, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-03

Locations

IL(3)US(10)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

LY2605541 First, Then Insulin Glargine

Insulin Glargine First, Then LY2605541

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations