A Study Comparing Insulin Peglispro With Insulin Glargine as Basal Insulin Treatment

NCT01894568 | Completed Phase 3 Results

• 2 other identifiers: 13422I2R-JE-BIAQ
• Study Type: interventional
• Target: 388
• Locations: 3 countries
• Sites: 31

Brief Summary

The purpose of this study is to compare insulin peglispro (LY2605541) to insulin glargine in Asian insulin naïve participants who have been treated with oral anti hyperglycemia medications. Participants will receive 26 weeks of treatment.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)

  Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein \[LDL-C\], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.

  Baseline, Week 26

Secondary Outcomes (17)

• 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events

  Baseline to Week 26

• Fasting Serum Glucose (FSG)

  Weeks 0 and 26

• Fasting Blood Glucose (FBG)

  Weeks 0 and 26

• Change From Baseline to Week 26 in Body Weight

  Baseline, Week 26

• 9-Point Self-Monitored Blood Glucose (SMBG)

  Week 0 and Week 26

Study Arms (2)

Insulin Peglispro

EXPERIMENTAL

Insulin Peglispro administered subcutaneously (SC) once daily for 26 weeks in combination with Oral Antihyperglycemic Medications (OAMs).

Drug: Insulin Peglispro; Drug: Oral Antihyperglycemic Medications (OAMs)

Insulin Glargine

ACTIVE COMPARATOR

Insulin Glargine administered SC once daily for 26 weeks in combination with OAMs.

Drug: Insulin Glargine; Drug: Oral Antihyperglycemic Medications (OAMs)

Interventions

Insulin Peglispro DRUG

Administered SC using a prefilled pen.

Also known as: LY2605541

Insulin Peglispro

Insulin Glargine DRUG

Administered SC using a prefilled pen

Insulin Glargine

Oral Antihyperglycemic Medications (OAMs) DRUG

Administered orally

Also known as: Sulfonylureas, Meglitinides, Dipeptidyl Peptidase-4 (DPP-IV) Inhibitors, Biguanides, α-Glucosidase Inhibitors, Pioglitazone

Insulin Glargine; Insulin Peglispro

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have Type 2 Diabetes Mellitus (T2DM) for at least 1 year not treated with insulin
• Have been receiving at least two oral antihyperglycemic medications (OAMs) for at least 3 months prior to screening
• Have Hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central laboratory at screening
• Body mass index (BMI) ≤35.0 kilogram per square meter (kg/m\^2)
• Inject insulin with a pre-filled insulin pen and perform Self-Monitored Blood Glucose (SMBG)
• Record keeping as required by this protocol
• Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening, do not plan to become pregnant during the study, have practiced reliable birth control during the study and 2 weeks following the last dose of investigational product

You may not qualify if:

• Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short term treatment of acute conditions
• Have been treated with rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist within 3 months prior to screening
• Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
• Local OAM restrictions: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
• Are taking, or have taken within 3 months before screening, prescription or over-the-counter medications to promote weight loss
• Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
• Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the past 6 months
• Have cardiac disease with functional status that is New York Heart Association Class III or IV
• Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2.0 milligram per deciliter (mg/dL) (177 micromole per liter \[μmol/L\]). Participants taking metformin should not exceed the creatinine level specified in the local label
• Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease \[NAFLD\]), acute or any chronic hepatitis, non alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements
• Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
• Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
• Have known hypersensitivity or allergy to any of LY2605541 and insulin glargine or their excipients
• Have pre proliferative and proliferative retinopathy, maculopathy requiring treatment or not clinically stable in the last 6 months, or participants with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months
• Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (31)

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.

Aichi, 455-8530, Japan

Location

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Chiba, 277-0825, Japan

Location

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Fukuoka, 807-0857, Japan

Location

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Hokkaido, 060-0062, Japan

Location

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Hyōgo, 662-0971, Japan

Location

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Ibaraki, 311-0113, Japan

Location

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Kagawa, 765-0071, Japan

Location

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Kanagawa, 247-0056, Japan

Location

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Kumamoto, 862-0976, Japan

Location

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Kyoto, 6150035, Japan

Location

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Miyagi, 980-0021, Japan

Location

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Miyazaki, 880-0034, Japan

Location

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Nagano, 399-0006, Japan

Location

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Osaka, 569-1096, Japan

Location

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Ōita, 8700039, Japan

Location

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Tochigi, 323-0022, Japan

Location

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Tokyo, 143-8541, Japan

Location

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Yamaguchi, 751-0815, Japan

Location

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Daegu, 700-712, South Korea

Location

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Incheon, 405-760, South Korea

Location

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Pusan, 602-739, South Korea

Location

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Seoul, 158-710, South Korea

Location

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Ulsan, 682-714, South Korea

Location

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Wŏnju, 220-701, South Korea

Location

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Sindian City, 23148, Taiwan

Location

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Taichung, 404, Taiwan

Location

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Taichung County, 433, Taiwan

Location

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Tainan, 70403, Taiwan

Location

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Taipei, 220, Taiwan

Location

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Yongkang District, 71004, Taiwan

Location

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Zhonghe, 235, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

basal insulin peglispro; LY2605541; Insulin Glargine; Sulfonylurea Compounds; meglitinide; Dipeptidyl Peptidase 4; Biguanides; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Dipeptidyl-Peptidases and Tripeptidyl-Peptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers; Guanidines; Amidines; Thiazolidinediones; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 15, 2019
• Results First Posted: March 15, 2019

Record last verified: 2019-03

Locations

JP (18); KR (6); TW (7)