A Study for Patients With Type 2 Diabetes

NCT ID: NCT01027871

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-01-31

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.

Detailed Description

Patients in this study will continue to use their stable prestudy dose of metformin and/or a sulfonylurea. Prestudy therapy also includes once daily insulin glargine or neutral protamine Hagedorn (NPH) insulin. The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will return to the basal insulin recommended by the investigator.

Conditions

Diabetes Mellitus, Type 2

Study Design

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

Study Groups

LY2605541 Dosing Algorithm 1

Participants took both LY2605541 and their pre-study insulin for first several days

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

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

LY2605541 Dosing Algorithm 2

Participants took only LY2605541 with first dose doubled

Group Type: EXPERIMENTAL

LY2605541

Intervention Type: DRUG

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

Insulin glargine

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks

Interventions

LY2605541

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

Intervention Type: DRUG

insulin glargine

subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• 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

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

• Minimum Eligible Age: 18 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.

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.

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.

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.

Coffs Harbour, New South Wales, Australia

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, South Australia, Australia

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Ringwood East, Victoria, Australia

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Fremantle, Western Australia, Australia

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Budapest, , Hungary

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Gyula, , Hungary

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Veszprém, , Hungary

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Bialystok, , Poland

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Lublin, , Poland

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Hato Rey, San Juan, Puerto Rico

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.

Manatí, , Puerto Rico

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.

San Juan, , Puerto Rico

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Cluj-Napoca, , Romania

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.

Iași, , Romania

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Târgu Mureş, , Romania

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Arkhangelsk, , Russia

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Moscow, , Russia

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.

Rostov-on-Don, , Russia

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.

Saint Petersburg, , Russia

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.

Alicante, , Spain

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Dos Hermanas, , Spain

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.

Málaga, , Spain

Countries

United States; Australia; Hungary; Poland; Puerto Rico; Romania; Russia; Spain

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)

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.

Reference Type: DERIVED

PMID: 24198302 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22787177 (View on PubMed)

Other Identifiers

I2R-MC-BIAC

Identifier Type: OTHER

Identifier Source: secondary_id

12149

Identifier Type: -

Identifier Source: org_study_id