Mode
Text Size
Log in / Sign up
Phase 3 Completed N=641 Randomized Treatment

A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes

Source: ClinicalTrials.gov NCT01790438 ↗
Enrolled (actual)
641
Serious AEs
5.8%
Results posted
May 2018
Primary outcomePrimary: Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) — -1.73; -1.36 percentage of HbA1c
◆ Published Evidence
Emerging
5citations · ~2 / year
Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.
Therapeutic innovation & regulatory science · 2023 · Likely link

Summary

The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participants that reach blood sugar targets without low night time blood sugar episodes * The total number of low blood sugar episodes reported

Linked Publications

  • Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.
    Therapeutic innovation & regulatory science · 2023 · 5 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)
-1.73; -1.36
SECONDARY
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
1.46; 1.73; 0.31; 0.61
SECONDARY
Percentage of Participants With HbA1c ≤6.5% and <7.0%
43.4; 24.1; 66.3; 44.7
SECONDARY
Fasting Serum Glucose (FSG) (by Laboratory)
112.61; 118.60
SECONDARY
Fasting Blood Glucose (FBG) (by Self Monitoring)
111.37; 109.75
SECONDARY
6-Point Self-Monitored Blood Glucose (SMBG)
111.22; 109.56; 123.78; 133.77; 130.90; 146.99
SECONDARY
Change From Baseline to 26 Weeks in Body Weight
2.02; 2.34
SECONDARY
HbA1c
6.76; 7.12
SECONDARY
Insulin Dose Per Kilogram (kg) of Body Weight
0.40; 0.35
SECONDARY
Time to Steady-State (Stable Maximum Dose)
7.14; 5.86
SECONDARY
Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index
0.02; 0.01
SECONDARY
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
85.04; 83.84
SECONDARY
Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores
0.53; 2.05
SECONDARY
Change From Baseline to 26 Weeks in Lipid Profile
2.08; 2.86; -0.12; 2.94; -0.24; 0.41
SECONDARY
Percentage of Participants With Insulin Antibodies
19.7; 45.8
SECONDARY
Intra-Participant Variability in FBG by Standard Deviation
14.44; 19.07
SECONDARY
Intra-Participant Variability in FBG by the Coefficient of Variation
12.87; 17.05
SECONDARY
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
76.7; 83.5; 41.6; 67.5
SECONDARY
Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia
39.1; 12.6
SECONDARY
Percentage of Participants With Injection Site Reactions
0.9; 1.4
SECONDARY
Rate of Severe Hypoglycemic Events
1.00; 0.00
SECONDARY
Percentage of Participants With Severe Hypoglycemic Events
0.5; 0.0
SECONDARY
Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores
2.52; 1.41

Eligibility Criteria

Inclusion Criteria

  • Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
  • Have been receiving 2 or more OAMs for at least 3 months prior to the study
  • Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening
  • Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
  • Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug

Exclusion Criteria

  • Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
  • Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening
  • For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
  • Are taking, or have taken within the 90 days 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 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 greater than or equal to 2 milligrams per deciliter (mg/dL) [177 millimoles per liter (mmol/L)]
  • Have obvious clinical signs or symptoms of liver disease [excluding nonalcoholic fatty liver disease (NAFLD)], acute or chronic hepatitis, nonalcoholic 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
  • 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
  • Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01790438) and the linked publication. 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.

Back to search