A Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment

This study is currently recruiting participants.
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01894568
First received: July 3, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to compare 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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: LY2605541
Drug: Insulin Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open Label, Randomized, Parallel, 26 Week Treatment Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti Hyperglycemia Medications in Asian Insulin Naïve Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: No ]
  • Fasting Serum Glucose (FSG) [ Time Frame: Baseline to Weeks 4, 8, 12, 16 and 26 ] [ Designated as safety issue: No ]
  • Fasting Blood Glucose (FBG) [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 26 Weeks in Body Weight [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • 9-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: No ]
  • Proportion of Participants with HbA1c ≤6.5% [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: No ]
  • Insulin Dose per Kilogram (kg) of Body Weight [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: No ]
  • Time to Steady State for Basal Insulin (Stable Maximum Dose) [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: No ]
  • Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline to 26 Weeks in Anti-LY2605541 Antibodies [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline to 26 Weeks in EuroQoL-5 Dimension (EQ-5D) Scores [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire (ITSQ) Score [ Time Frame: Week 4 and 26 ] [ Designated as safety issue: No ]
  • Change from Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Intra-Participant Variability of the Fasting Blood Glucose (FBG) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 12 Weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Total and Nocturnal Hypoglycemic Events [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: July 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2605541
LY2605541 administered subcutaneously (SC) once daily for 26 weeks.
Drug: LY2605541
Administered SC using a prefilled pen.
Active Comparator: Insulin Glargine
Insulin Glargine administered SC once daily for 26 weeks.
Drug: Insulin Glargine
Administered SC using a prefilled pen

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening as determined by the central laboratory
  • Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01894568

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
Japan
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. Recruiting
Aichi, Japan, 455-8530
Contact: Eli Lilly         
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. Recruiting
Chiba, Japan, 277-0825
Contact: Eli Lilly         
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. Recruiting
Fukuoka, Japan, 820-8505
Contact: Eli Lilly         
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. Recruiting
Hokkaido, Japan, 060-0062
Contact: Eli Lilly         
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. Recruiting
Hyogo, Japan, 662-0971
Contact: Eli Lilly         
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. Recruiting
Ibaraki, Japan, 310-0845
Contact: Eli Lilly         
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. Recruiting
Kagawa, Japan, 765-0071
Contact: Eli Lilly         
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. Recruiting
Kanagawa, Japan, 247-0056
Contact: Eli Lilly         
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. Recruiting
Kumamoto, Japan, 862-0976
Contact: Eli Lilly         
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. Recruiting
Kyoto, Japan, 6150035
Contact: Eli Lilly         
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. Recruiting
Miyagi, Japan, 980-0021
Contact: Eli Lilly         
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. Recruiting
Miyazaki, Japan, 880-0034
Contact: Eli Lilly         
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. Active, not recruiting
Nagano, Japan, 399-0006
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. Recruiting
Ooita, Japan, 8700039
Contact: Eli Lilly         
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. Recruiting
Osaka, Japan, 569-1096
Contact: Eli Lilly         
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. Recruiting
Tochigi, Japan, 323-0022
Contact: Eli Lilly         
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. Recruiting
Tokyo, Japan, 143-8541
Contact: Eli Lilly         
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. Recruiting
Yamaguchi, Japan, 754-0002
Contact: Eli Lilly         
Korea, Republic of
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. Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Eli Lilly         
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. Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Eli Lilly         
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. Recruiting
Pusan, Korea, Republic of, 602-739
Contact: Eli Lilly         
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. Recruiting
Seoul, Korea, Republic of, 158-710
Contact: Eli Lilly         
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. Recruiting
Ulsan-Si, Korea, Republic of, 682-714
Contact: Eli Lilly         
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. Recruiting
Wonju-Si, Korea, Republic of, 220-701
Contact: Eli Lilly         
Taiwan
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. Recruiting
Jhonghe City, Taiwan, 235
Contact: Eli Lilly         
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. Recruiting
Sindian City, Taiwan, 23148
Contact: Eli Lilly         
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. Recruiting
Taichung, Taiwan, 404
Contact: Eli Lilly         
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. Recruiting
Taichung County, Taiwan, 433
Contact: Eli Lilly         
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. Recruiting
Tainan, Taiwan, 70403
Contact: Eli Lilly         
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. Recruiting
Taipei, Taiwan, 220
Contact: Eli Lilly         
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. Recruiting
Yong Kung City, Taiwan, 71004
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01894568     History of Changes
Other Study ID Numbers: 13422, I2R-JE-BIAQ
Study First Received: July 3, 2013
Last Updated: March 14, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Taiwan : Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014