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Phase 3 Completed N=1,538 Randomized Double-blind Treatment

A Study in Patients With Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT01435616 ↗
Enrolled (actual)
1,538
Serious AEs
11.6%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) — -1.55; -1.25 percentage of HbA1c

Summary

The purpose of this study is: * To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. * To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment. * To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
-1.55; -1.25
SECONDARY
Rate of Total and Nocturnal Hypoglycemia Events
1.16; 1.21; 0.30; 0.40
SECONDARY
Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %
36.1; 23.9; 57.6; 42.8
SECONDARY
Fasting Serum Glucose (By Laboratory Measurement)
114.93; 120.13
SECONDARY
Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)
112.57; 112.00
SECONDARY
6 Point Self-monitored Blood Glucose (SMBG)
112.81; 112.26; 127.65; 134.52; 133.94; 142.58
SECONDARY
Change From Baseline to 52 Weeks in Body Weight
2.06; 2.57
SECONDARY
Hemoglobin A1c
6.91; 7.21
SECONDARY
Insulin Dose Per Body Weight
0.45; 0.42
SECONDARY
Number of Insulin Dose Adjustments to Steady-State
5.83; 5.25
SECONDARY
European Quality of Life-5 Dimension (EQ-5D)
0.88; 0.88
SECONDARY
Insulin Treatment Satisfaction Questionnaire
84.73; 85.04
SECONDARY
Adult Low Blood Sugar Survey
15.09; 14.59
SECONDARY
Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)
10.60; -7.33; 1.44; 1.76; -1.91; -1.82
SECONDARY
Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin
0.2; 0.0; 0.1; 0.0
SECONDARY
Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)
43.0; 37.8
SECONDARY
Intra-participant Variability of the Fasting Blood Glucose (FBG)
15.56; 17.08
SECONDARY
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
77.0; 79.8; 48.9; 59.8
SECONDARY
Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia
17.5; 8.6; 26.2; 15.3
SECONDARY
Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
6.5; 4.0; 1.9; 0.6; 3.6; 1.5

Eligibility Criteria

Inclusion Criteria

  • Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
  • Have been receiving at least 2 OAMs for at least 3 months before entering the study
  • Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
  • Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
  • Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug

Exclusion Criteria

  • Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
  • Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
  • Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
  • Have had any episodes of severe hypoglycemia within 6 months prior to screening
  • Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)
  • Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)
  • Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
  • 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 malignancy or have been in remission from clinically significant malignancy for less than 5 years
  • Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter [mmol/L]) at screening
  • Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
  • Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01435616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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