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A Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01894568
First received: July 3, 2013
Last updated: July 21, 2014
Last verified: July 2014

July 3, 2013
July 21, 2014
July 2013
January 2015   (final data collection date for primary outcome measure)
Change from Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01894568 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study Comparing LY2605541 With Insulin Glargine as Basal Insulin Treatment
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: LY2605541
    Administered SC using a prefilled pen.
  • Drug: Insulin Glargine
    Administered SC using a prefilled pen
  • Experimental: LY2605541
    LY2605541 administered subcutaneously (SC) once daily for 26 weeks.
    Intervention: Drug: LY2605541
  • Active Comparator: Insulin Glargine
    Insulin Glargine administered SC once daily for 26 weeks.
    Intervention: Drug: Insulin Glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
380
April 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Taiwan
 
NCT01894568
13422, I2R-JE-BIAQ
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP