A Study for Patients With Type 1 Diabetes

NCT ID: NCT01049412

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-01-31

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

Detailed Description

Prestudy treatment for patients who enter this study will be once daily insulin glargine along with mealtime insulins. Patients will continue to use their mealtime insulins throughout the study. The study will consist of 16 weeks of treatment and 4 weeks of follow-up. The 16 weeks of treatment will consist of two 8-week periods (Periods 1 and 2) during which patients will receive insulin glargine for 8 weeks and LY2605541 for 8 weeks in a random sequence. During the 4-week follow-up period, patients will return to insulin glargine or another basal insulin recommended by the investigator.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LY2605541 First, Then Insulin Glargine

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

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

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

Insulin glargine

Intervention Type: DRUG

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 LY2605541

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

Group Type: ACTIVE_COMPARATOR

LY2605541

Intervention Type: DRUG

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

Insulin glargine

Intervention Type: DRUG

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

Interventions

LY2605541

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

Intervention Type: DRUG

Insulin glargine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 2 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
• Fasting triglycerides greater than 500 milligram per deciliter (mg/dL)
• Liver disease
• History of renal transplantation, current renal dialysis, or creatinine greater than 2.0 mg/dL (177 micromole per liter [μmol/L])
• Malignancy other than basal cell or squamous cell skin cancer, currently or within the last 5 years
• Treatment with any antibody-based therapy within 6 months prior to the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

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, United States

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.

Atlanta, Georgia, United States

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.

Idaho Falls, Idaho, United States

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.

Topeka, Kansas, United States

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.

Metairie, Louisiana, United States

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.

Baltimore, Maryland, United States

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.

Minneapolis, Minnesota, United States

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.

Austin, Texas, United States

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.

Dallas, Texas, United States

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.

Renton, Washington, United States

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.

Holon, , Israel

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.

Petah Tikva, , Israel

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.

Tel Litwinsky, , Israel

Countries

United States; Israel

References

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.

Reference Type: BACKGROUND

PMID: 15855602 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36542287 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26278063 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23193209 (View on PubMed)

Other Identifiers

I2R-MC-BIAD

Identifier Type: OTHER

Identifier Source: secondary_id

12151

Identifier Type: -

Identifier Source: org_study_id